Intubating laryngeal airway vs. direct laryngoscope: a crossover randomized controlled neonatal manikin trial

Intubating laryngeal airway vs. direct laryngoscope: a crossover randomized controlled neonatal manikin trial | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article Intubating laryngeal airway vs. direct laryngoscope: a crossover randomized controlled neonatal manikin trial Chiara Monfredini, Francesco Cavallin, Paul Ouedraogo, Leila Ezzahraoui, and 3 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-6047892/v1 This work is licensed under a CC BY 4.0 License Status: Published Journal Publication published 20 Jun, 2025 Read the published version in Italian Journal of Pediatrics → Version 1 posted 4 You are reading this latest preprint version Abstract Background: We aimed to compare endotracheal intubation through a laryngeal mask vs. using a direct laryngoscope in a manikin simulating a term infant. Methods: A randomized, controlled, crossover (AB/BA) trial of intubation through a laryngeal mask vs. a direct laryngoscope in a manikin simulating a term infant. Thirty-four tertiary neonatal intensive care unit consultants and pediatric residents who had previous experience with intubating laryngeal airway and direct laryngoscopy participated. The primary outcome measure was the success of the procedure at the first attempt. The secondary outcome measures included the total time of endotracheal tube positioning and participant’s opinion on insertion difficulty and overall difficulty. Results: Success at first attempt was 34/34 with the laryngeal mask (100%) and 26/34 with thedirect laryngoscope (76%) (difference in percentage 24%, 95% confidence interval 5% to 41%; p=0.008). Median time of endotracheal tube positioning was 24 seconds (IQR 19-30) with both devices (p=0.86). Insertion difficulty (p=0.96) and overall difficulty (p=0.99) were not statistically different between the devices. Conclusions: In a term infant manikin model, positioning the endotracheal tube through the laryngeal mask increased the success at the first attempt compared to direct laryngoscopy, without extending the duration of the procedure or affecting the perceived difficulty. Registration: clinicaltrial.gov NCT06263790. Registered 16 February 2024, https://clinicaltrials.gov/study/NCT06263790 direct laryngoscopy endotracheal intubation laryngeal mask manikin term infant Figures Figure 1 Figure 2 Figure 3 KEY NOTES Direct laryngoscopy and tracheal intubation are invasive procedures which may be associated with bradycardia, hypoxia, airway trauma, and intraventricular hemorrhage. Using the laryngeal mask as a guide to introduce a tracheal tube allows to avoid the direct laryngoscopy, may increase the intubation success rate reducing laryngoscopy-related adverse events. In a manikin simulating a term neonate, using a laryngeal mask led to a higher intubation success at the first attempt compared to direct laryngoscopy without extending the duration of the procedure or affecting the perceived difficulty. INTRODUCTION Intubating at birth is required in about 1% of neonates ( 1 ). However, health care providers have been progressively less exposed to neonatal intubation because of the implementation of less invasive procedures, such as continuous positive airway pressure and nasal intermittent positive pressure ventilation ( 2 , 3 ). Pediatric residents and neonatology fellows may have a broad range of success rates (20–70%) in performing neonatal intubation ( 4 ). The laryngoscopy is an invasive procedure which may be associated with direct trauma to the tissues and may lead to adverse reactions ( 5 – 7 ). Adverse events have been frequently reported during neonatal intubation, including bradycardia, hypoxia, esophageal intubation, airway trauma, and intraventricular hemorrhage ( 6 , 8 , 9 ). Using the laryngeal mask as a guide to introduce a tracheal tube allows to avoid the direct laryngoscopy, may increase the intubation success rate reducing laryngoscopy-related adverse events, especially with less experienced personnel ( 10 , 11 ). The 2022 recommendations from International Liaison Committee on Resuscitation (ILCOR) and the 2023 update of the American Heart Association Guidelines suggested that a laryngeal mask may be used as primary interface for administering positive pressure ventilation immediately after birth in newborn infants delivered at ≥ 34 0/7 weeks’ gestation ( 12 , 13 ). Recently, neonatal sizes of laryngeal masks have become available. This trial aimed to compare intubation with laryngeal mask vs. direct laryngoscopy in a manikin simulating a term neonate. Moreover, the time of endotracheal tube positioning and participant’s opinion on difficulty of the procedure were investigated. METHODS Study design This was a randomized, controlled, crossover (AB/BA) trial of intubation through a laryngeal mask vs. direct laryngoscopy in a manikin simulating a term infant (clinicaltrial.gov NCT06263790). The manikin trial was reviewed and approved by the Ethics Committees of the participating centers (Prot. 535n/AO/24 and G1.2024.0002222). All participants provided written informed consent. Setting This simulation trial was conducted at the University Hospital of Padua (Italy) and the Fondazione Poliambulanza of Brescia (Italy) between 18th and 22nd March 2024. The scenario consisted of a term infant needing intubation (neonatal simulator manikin: Laerdal NewBorn Anne; Laerdal, Stavanger, Norway). Participants Level III neonatal intensive care unit (NICU) consultants and pediatric residents who had previous experience with intubating laryngeal airway and direct laryngoscopy were eligible to participate in the study. Refusal to participate was the only exclusion criteria. Randomization All participants were randomly allocated to AB or BA arms in a 1:1 ratio. The randomization order was prepared using a computer-generated random assignment list in R 4.3 (R Foundation for Statistical Computing, Vienna, Austria) ( 14 ). Arm assignments were put in sequentially numbered, sealed, opaque envelopes. Procedures Participants in AB arm were allocated to position the endotracheal tube in the manikin through a laryngeal mask (size 0.5 air-Qsp, Cookgas, Northridge, MI, USA), followed by the procedure using a standard direct laryngoscope with Miller blade size 1. Participants in BA arm were allocated to the inverse sequence. A washout period of 6 hours (one procedure in the morning and one in the afternoon) was included to reduce any carryover effect. An external observer recorded the study outcomes during each simulation. When using the laryngeal mask, each participant was asked to i) place the laryngeal mask, ii) check the effective ventilation through the laryngeal mask, iii) insert a well‑lubricated endotracheal tube (size 3.5 mm), iv) check the effective ventilation through the endotracheal tube, v) insert the exchange removal stylet to stabilize the tracheal tube, vi) remove the laryngeal mask, and vii) start the positive pressure ventilation through the endotracheal tube (Fig. 1 ). When using the direct laryngoscope, each participant was asked to i) insert the laryngoscope, ii) visualize the glottis, iii) insert the endotracheal tube, and iv) start the positive pressure ventilation through the endotracheal tube (Fig. 1 ). At the end of the first attempt, the correct positioning of the endotracheal tube was evaluated by the external observer using a laryngoscope; if the attempt failed, the procedure was repeated until achievement of the correct positioning. The total time of endotracheal tube positioning was calculated as the sum of the times of all attempts needed to achieve a correct positioning. At the end of each simulation, the participants were asked to score the insertion difficulty and the overall difficulty of the procedures using a Likert scale (from 1 = not difficult to 5 = very difficult). Outcome measures The primary outcome measure was the success of the procedure at the first attempt, defined as the achievement of the correct positioning of the endotracheal tube in the trachea as assessed by the external observer. The secondary outcome measures included the total time of endotracheal tube positioning (calculated as the sum of the time of endotracheal tube positioning in all attempts, as the procedure was repeated in case of incorrect positioning) and participant’s opinion on insertion difficulty and overall difficulty of the procedures (assessed using a Likert scale). Data collection Randomization sequence, participant’s demographics and experience, and data on outcome measures were recorded by a researcher who was not involved in the simulation. All data were collected in a dedicated data sheet and stored in a password-protected computer to ensure confidentiality before, during, and after the trial. Masking The procedures did not allow the masking of the participants and the outcome assessors. However, the statistician who carried out the data analysis was masked to the treatment assignment. Sample size The literature did not offer any useful information on the primary outcome measure that could be used to inform the sample size calculation during the study design. Hence, we aimed to enroll all eligible subjects in the participating centers during the trial period (24 to 34 participants). In a crossover design, such sample sizes had the chance of detecting an effect size ranging from 20–26% with 80% power and ranging from 23–31% with 90% power. Sample size calculation was performed using R 4.3 (R Foundation for Statistical Computing, Vienna, Austria) ( 14 ). Statistical analysis The crossover design implemented an AB/BA scheme, which is uniform within sequences and periods (thus removing any period and sequence effects), and included a reasonable washout period to prevent any carryover effects. The categorical variables were summarized as absolute frequency and percentage, and the numerical variables as median and interquartile range (IQR). The binary outcome measure (correct positioning of the endotracheal tube in the trachea at the first attempt) was compared between the study arms using the McNemar test, and the effect size was reported as difference in proportion for paired data with 95% confidence interval ( 15 ). The numerical outcome measures (total time of endotracheal tube positioning and participant's opinion were compared between the study arms using the quantile test, and the effect sizes were reported as median difference with bootstrap 95% confidence interval. All tests were 2-sided and a p-value less than 0.05 was considered statistically significant. Statistical analysis was performed using R 4.4 (R Foundation for Statistical Computing, Vienna, Austria) ( 14 ). RESULTS The trial included 34 participants (10 males and 24 females) who were randomly assigned to the trial arms (Fig. 2 ). Median experience in neonatal intensive care was 3 years (IQR 1–14). Experience in positioning a laryngeal mask in newborns was > 20 cases in four participants, 10–20 cases in two participants, 5–10 cases in three participants and 20 cases in 16 participants, 10–20 cases in three participants, 5–10 cases in five participants and 20 cases in seven participants, 10–20 cases in four participants, 5–10 cases in six participants and 20 cases in 11 participants, 10–20 cases in eight participants, 5–10 cases in five participants and < 5 cases in 10 participants. The correct positioning of the endotracheal tube in the trachea was achieved at the first attempt by all participants with the laryngeal mask (100%) and 26 participants with the Miller laryngoscope (76%) (difference in percentage 24%, 95% confidence interval 5–41%; p = 0.008) (Table 1 ). Table 1 Outcome measures Outcome measures Intubation via intubating laryngeal airway (n = 34) Intubation via Miller laryngoscope (n = 34) Comparison of intubating laryngeal airway vs. Miller laryngoscope Primary outcome measure p-value (McNemar test) Difference in percentage for paired data (95% confidence interval) Correct positioning of the endotracheal tube in the trachea at the first attempt: n (%) 34 (100%) 26 (76%) 0.008 24% (5–41%) Secondary outcome measure p-value (quantile test) Median difference (bootstrap 95% confidence interval) Total time of endotracheal tube positioning, seconds: median (IQR) 24 (19–30) 24 (19–30) 0.99 0 (-4 to 4) Participant's opinion on insertion difficulty of the procedure, Likert scale (1 = not difficult, 5 = very difficult): median (IQR) 1 ( 1 – 2 ) 2 ( 2 – 3 ) 0.86 -1 (-1 to 0) Participant's opinion on overall difficulty of the procedure, Likert scale (1 = not difficult, 5 = very difficult): median (IQR) 2 ( 1 – 2 ) 2 ( 2 – 3 ) 0.99 -0.5 (-1 to 0) Median time of endotracheal tube positioning was 24 seconds (IQR 19–30) with both the laryngeal mask and the Miller laryngoscope (p = 0.99) (Table 1 ). Participants’ opinions about insertion difficulty and overall difficulty when intubating via the laryngeal mask or the Miller laryngoscope are displayed in Fig. 3 . The comparison of the insertion difficulty (p = 0.86) and the overall difficulty (p = 0.99) did not provide any statistically significant difference between the laryngeal mask and the Miller laryngoscope (Table 1 ). DISCUSSION In our trial, using an air-Qsp intubating laryngeal airway led to a higher intubation success at the first attempt compared to direct laryngoscopy in a manikin simulating a term neonate. Nonetheless, the time of endotracheal tube positioning and participant’s opinion on difficulty of the procedure were comparable between the two approaches. Intubation is a required skill for all healthcare workers involved in the care of the newborns, but is difficult to acquire and has a long learning curve. Moreover, the reduced exposure to neonatal intubation impairs the chance of achieving and sustaining proficiency in this skill ( 2 – 4 , 16 – 18 ). Implementing strategies to enhance intubation success is likely to improve safety outcomes ( 19 ). Intubating through a laryngeal mask may offer some advantages over laryngoscopy including easiness of the procedure and avoidance of laryngoscopy-associated side effects ( 20 , 21 ). The intubating laryngeal mask (also known as the LMA-Fastrach) is a modified laryngeal mask airway which was developed to ease tracheal intubation either as blind or fiber-optic-assisted procedure ( 22 , 23 ). The literature suggests easiness of use, short training, high success rate of positioning and adequate oxygenation during tracheal intubation attempts among the benefits of the intubating laryngeal airway, as well as less hemodynamic change and injury to teeth/lips compared to direct laryngoscopy in adults ( 21 ). Nonetheless, potential drawbacks may involve esophageal intubation and damage to epiglottis, larynx or other tissues during the blind passage of the tracheal tube ( 21 ). So far, previous studies were limited to adult and pediatric patients as intubating laryngeal airways for neonates have become available only recently. Our trial confirmed the higher intubation success using the air-Qsp intubating laryngeal airway compared to direct laryngoscopy in a manikin simulating a term neonate. Positioning the endotracheal tube through the laryngeal mask may extend the duration of the procedure because it involves more actions due to the handling of two devices (insertion of the laryngeal mask, insertion of the endotracheal tube, and removal of the laryngeal mask). In our trial, using the air-Qsp intubating laryngeal airway did not delay the time of endotracheal tube positioning compared to direct laryngoscopy, and most procedures were performed within the recommended time of 30 seconds ( 24 ). We may speculate that positioning the endotracheal tube by using the laryngoscope benefited from the less actions involved but required some time to visualize the glottis. Of note, the participants reported comparable insertion difficulty and overall difficulty of the procedure when using the laryngeal mask or the direct laryngoscope. Although the literature underlines the easiness of use of the laryngeal mask ( 21 , 25 ), we believe that the heterogeneous experience of the participants with both devices in simulation settings and the higher experience with laryngoscopy in clinical practice might have levelled the perceived difficulty of the procedures. The strengths of the trial include the crossover design and the participation of health care providers with heterogeneous level of experience with the two approaches. Our findings may provide useful information to health care providers involved in neonatal airway management. However, the study also has some limitations that should be considered. The simulated scenario and the manikin provided a safe and low stress setting for the participants. Moreover, the simulation did not offer clinical information, hence the clinical implications of the findings could only be speculated. Finally, the generalizability of the results should be restricted to health care staff with similar background, although our participants reported a heterogeneous level of experience with laryngeal mask and direct laryngoscopy. CONCLUSIONS In a term manikin model, positioning the endotracheal tube through the air-Qsp intubating laryngeal airway increased the success at the first attempt compared to direct laryngoscopy. Furthermore, using the intubating the laryngeal mask did not extend the duration of the procedure or affected the insertion difficulty and overall difficulty of the procedure as perceived by the operator. Further studies should confirm these findings in clinical settings. Declarations Ethics approval and consent to participate. The trial was reviewed and approved by the Ethics Committees of the participating centers (Prot. 535n/AO/24 and G1.2024.0002222). All participants provided written informed consent. Consent for publication. Not applicable. Availability of data and materials All data are available upon reasonable request by contacting the corresponding author. Competing interests The authors declare that they have no competing interests. Funding No specific funding was used for the present study. Authors’ contributions CM contributed tothe conceptualization, investigation, data curation, writing original draft, and review & editing. FC analyzed the data and contributed tothe methodology, writing original draft andreview & editing. POcontributed to the methodology, conceptualization, investigation, writing, and review & editing; LE contributed to the investigation, data collection, writing, and review & editing; EP contributed to the investigation, data collection, writing, and review & editing; DT contributed to the conceptualization, methodology, supervision, writing, and review & editing; PEV contributed to the conceptualization, methodology, supervision, writing, and review & editing. Acknowledgements We would like to thank all participants in the study References Madar J, Roehr CC, Ainsworth S, Ersdal H, Morley C, Rüdiger M, Skåre C, Szczapa T, Te Pas A, Trevisanuto D, Urlesberger B, Wilkinson D, Wyllie JP. European Resuscitation Council Guidelines 2021: Newborn resuscitation and support of transition of infants at birth. Resuscitation 2021;161:291-326. Leone TA, Rich W, Finer NN. Neonatal intubation: success of pediatric trainees. J Pediatr 2005;146:638-41. Pinheiro JMB. Neonatal Airway Management. Children (Basel). 2024;11(1):82. Sawyer T, Foglia E, Hatch LD, Moussa A, Ades A, Johnston L, Nishisaki A. Improving neonatal intubation safety: A journey of a thousand miles. J Neonatal Perinatal Med 2017;10:125-31. Hassan HG, El-Sharkawy TY, Renck H, Mansour G, Fouda A. Hemodynamic and catecholamine responses to laryngoscopy with vs. without endotracheal intubation. Acta Anaesthesiol Scand 1991;35:442-7. Foglia EE, Ades A, Sawyer T, Glass KM, Singh N, Jung P, Quek BH, Johnston LC, Barry J, Zenge J, Moussa A, Kim JH, DeMeo SD, Napolitano N, Nadkarni V, Nishisaki A; NEAR4NEOS Investigators. Neonatal Intubation Practice and Outcomes: An International Registry Study. Pediatrics 2019;143:e20180902. Inoue A, Okamoto H, Hifumi T, Goto T, Hagiwara Y, Watase H, Hasegawa K; Japanese Emergency Medicine Network Investigators. The incidence of post-intubation hypertension and association with repeated intubation attempts in the emergency department. PLoS One. 2019;14(2):e0212170. Hatch LD, Grubb PH, Lea AS, Walsh WF, Markham MH, Whitney GM, Slaughter JC, Stark AR, Ely EW. Endotracheal Intubation in Neonates: A Prospective Study of Adverse Safety Events in 162 Infants. J Pediatr 2016;168:62-66.e6. Sauer CW, Kong JY, Vaucher YE, Finer N, Proudfoot JA, Boutin MA, Leone TA. Intubation Attempts Increase the Risk for Severe Intraventricular Hemorrhage in Preterm Infants-A Retrospective Cohort Study J Pediatr. 2016;177:108-13. Gerstein NS, Braude DA, Hung O, Sanders JC, Murphy MF. The Fastrach Intubating Laryngeal Mask Airway: an overview and update. Can J Anaesth. 2010;57(6):588-601. Lee DH, Stang J, Reardon RF, Martel ML, Driver BE, Braude DA. Rapid Sequence Airway with the Intubating Laryngeal Mask in the Emergency Department. J Emerg Med. 2021;61(5):550-557. Yamada NK, McKinlay CJD, Quek BH, Rabi Y, Costa-Nobre DT, de Almeida MF, Davis PG, El-Naggar W, Fabres JG, Fawke J, Foglia EE, Guinsburg R, Hosono S, Isayama T, Kapadia VS, Kawakami MD, Kim HS, Lee H, Liley HG, Madar RJ, Nakwa FL, Perlman JM, Roehr CC, Rüdiger M, Schmölzer GM, Sugiura T, Trevisanuto D, Wyckoff MH, Wyllie JP, Weiner GM. Supraglottic airways for neonatal resuscitation (NLS#618/5340 [Internet] Brussels, Belgium. International Liaison Committee on Resuscitation (ILCOR) Neonatal Life Support Task Force, Available from http://ilcor.org Yamada NK, Szyld E, Strand ML, Finan E, Illuzzi JL, Kamath-Rayne BD, Kapadia VS, Niermeyer S, Schmölzer GM, Williams A, Weiner GM, Wyckoff MH, Lee HC; American Heart Association and American Academy of Pediatrics. 2023 American Heart Association and American Academy of Pediatrics Focused Update on Neonatal Resuscitation: An Update to the American Heart Association Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. Circulation. 2024;149(1):e157-e166.. R Core Team R (2024). A language and environment for statistical computing. R Foundation for Statistical Computing, Vienna, Austria. Fay MP, Lumbard K. Confidence Intervals for Difference in Proportions for Matched Pairs Compatible with Exact McNemars or Sign Tests. Statistics in Medicine. 2021;40(5):1147-115. Doglioni N, Cavallin F, Zanardo V, Trevisanuto D. Intubation training in neonatal patients: a review of one trainee's first 150 procedures. J Matern Fetal Neonatal Med. 2012;25(8):1302-4. Haubner LY, Barry JS, Johnston LC, Soghier L, Tatum PM, Kessler D, Downes K, Auerbach M. Neonatal intubation performance: room for improvement in tertiary neonatal intensive care units. Resuscitation. 2013;84(10):1359-64. Uchinami Y, Fujita N, Ando T, Mizunoya K, Hoshino K, Yokota I, Morimoto Y. The relationship between years of anesthesia experience and first-time intubation success rate with direct laryngoscope and video laryngoscope in infants: a retrospective observational study. J Anesth. 2022;36(6):707-714. Herrick HM, O’Reilly MA, Foglia EE. Success rates and adverse events during neonatal intubation: Lessons learned from an international registry. Semin Fetal Neonatal Med. 2023 Oct 1;28(5):101482 Caponas G. Intubating laryngeal mask airway. Anaesth Intensive Care. 2002;30(5):551-69. Young B. The intubating laryngeal-mask airway may be an ideal device for airway control in the rural trauma patient. Am J Emerg Med. 2003;21(1):80-5. Brain AI, Verghese C, Addy EV, Kapila A. The intubating laryngeal mask. I: Development of a new device for intubationof the trachea. Br J Anaesth 1997; 79:699-703. Ferson DZ, Brimacombe J, Brain AI, Verghese C. The intubating laryngeal mask airway. Int Anesthesiol Clin 1998;36:183-209. American Academy of Pediatrics and American Heart Association. Textbook of Neonatal Resuscitation. Ed. Gary M. Weiner, Jeanette Zaichkin. 8th Edition, 2021. Trevisanuto D, Micaglio M, Ferrarese P, Zanardo V. The laryngeal mask airway: potential applications in neonates. Arch Dis Child Fetal Neonatal Ed. 2004;89(6):F485-9. Cite Share Download PDF Status: Published Journal Publication published 20 Jun, 2025 Read the published version in Italian Journal of Pediatrics → Version 1 posted Reviewers agreed at journal 05 Apr, 2025 Reviewers invited by journal 04 Apr, 2025 First submitted to journal 31 Mar, 2025 Editor assigned by journal 31 Mar, 2025 You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. We do this by developing innovative software and high quality services for the global research community. Our growing team is made up of researchers and industry professionals working together to solve the most critical problems facing scientific publishing. Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-6047892","acceptedTermsAndConditions":true,"allowDirectSubmit":false,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":438576410,"identity":"c010eba3-1688-4f9e-95cb-866686ad273b","order_by":0,"name":"Chiara Monfredini","email":"data:image/png;base64,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","orcid":"https://orcid.org/0009-0000-8094-1369","institution":"Poliambulanza Foundation Hospital Institute: Fondazione Poliambulanza Istituto Ospedaliero","correspondingAuthor":true,"prefix":"","firstName":"Chiara","middleName":"","lastName":"Monfredini","suffix":""},{"id":438576411,"identity":"24548b0e-8c24-4f6a-965b-ae920bdc4365","order_by":1,"name":"Francesco Cavallin","email":"","orcid":"","institution":"Independent statistician Solagna","correspondingAuthor":false,"prefix":"","firstName":"Francesco","middleName":"","lastName":"Cavallin","suffix":""},{"id":438576412,"identity":"885538e3-6d50-4a91-b4c8-60a208ea0aab","order_by":2,"name":"Paul Ouedraogo","email":"","orcid":"","institution":"Hopital Saint Camille, Ouagadougou, Burkina Faso","correspondingAuthor":false,"prefix":"","firstName":"Paul","middleName":"","lastName":"Ouedraogo","suffix":""},{"id":438576413,"identity":"e00ded53-4c5e-45b5-8eb9-4649de212bb8","order_by":3,"name":"Leila Ezzahraoui","email":"","orcid":"","institution":"Padua University Hospital: Azienda Ospedale Universita Padova","correspondingAuthor":false,"prefix":"","firstName":"Leila","middleName":"","lastName":"Ezzahraoui","suffix":""},{"id":438576414,"identity":"f709adc8-6390-47e9-97f7-d6b297331d3a","order_by":4,"name":"Elisa Pasta","email":"","orcid":"","institution":"Poliambulanza Foundation Hospital Institute: Fondazione Poliambulanza Istituto Ospedaliero","correspondingAuthor":false,"prefix":"","firstName":"Elisa","middleName":"","lastName":"Pasta","suffix":""},{"id":438576415,"identity":"841829b4-747f-4a2c-8a4c-72277207f5e1","order_by":5,"name":"Daniele Trevisanuto","email":"","orcid":"","institution":"Padua University Hospital: Azienda Ospedale Universita Padova","correspondingAuthor":false,"prefix":"","firstName":"Daniele","middleName":"","lastName":"Trevisanuto","suffix":""},{"id":438576416,"identity":"49be0967-4b9f-44b1-a95e-939be20f6db4","order_by":6,"name":"Paolo Ernesto Villani","email":"","orcid":"","institution":"Poliambulanza Foundation Hospital Institute: Fondazione Poliambulanza Istituto Ospedaliero","correspondingAuthor":false,"prefix":"","firstName":"Paolo","middleName":"Ernesto","lastName":"Villani","suffix":""}],"badges":[],"createdAt":"2025-02-17 12:24:00","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-6047892/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-6047892/v1","draftVersion":[],"editorialEvents":[{"content":"https://doi.org/10.1186/s13052-025-01988-8","type":"published","date":"2025-06-20T15:57:00+00:00"}],"editorialNote":"","failedWorkflow":false,"files":[{"id":80580495,"identity":"c236d557-9248-4cbc-8838-7aa0d6856ec9","added_by":"auto","created_at":"2025-04-14 23:15:39","extension":"png","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":139057,"visible":true,"origin":"","legend":"\u003cp\u003eScheme and timing of the procedures. ET: endotracheal tube. LM: laryngeal mask.\u003c/p\u003e","description":"","filename":"Figure1Rev1.png","url":"https://assets-eu.researchsquare.com/files/rs-6047892/v1/85c9d5b8b888c712ae0d2bec.png"},{"id":80580496,"identity":"4051231a-1be7-491d-9488-bd8930511c81","added_by":"auto","created_at":"2025-04-14 23:15:39","extension":"png","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":447033,"visible":true,"origin":"","legend":"\u003cp\u003eCONSORT flow diagram.\u003c/p\u003e","description":"","filename":"Figure2.png","url":"https://assets-eu.researchsquare.com/files/rs-6047892/v1/5ddf2817917a01666e52d631.png"},{"id":80581867,"identity":"21465985-5831-4646-b391-2e1d5a96447f","added_by":"auto","created_at":"2025-04-14 23:23:39","extension":"png","order_by":3,"title":"Figure 3","display":"","copyAsset":false,"role":"figure","size":136049,"visible":true,"origin":"","legend":"\u003cp\u003eParticipants’ opinions about insertion difficulty (A) and overall difficulty (B) when intubating via laryngeal mask or direct laryngoscope (evaluated using a Likert scale).\u003c/p\u003e","description":"","filename":"Figure3.png","url":"https://assets-eu.researchsquare.com/files/rs-6047892/v1/a6796635156f8113c1e4554f.png"},{"id":85231422,"identity":"58fc5e63-156b-492f-b3fa-fc54cef1240f","added_by":"auto","created_at":"2025-06-23 16:07:44","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":1497960,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-6047892/v1/c4602a90-a089-441d-86c6-78183001722c.pdf"}],"financialInterests":"","formattedTitle":"Intubating laryngeal airway vs. direct laryngoscope: a crossover randomized controlled neonatal manikin trial","fulltext":[{"header":"KEY NOTES","content":"\u003cp\u003eDirect laryngoscopy and tracheal intubation are invasive procedures which may be associated with bradycardia, hypoxia, airway trauma, and intraventricular hemorrhage.\u003c/p\u003e\n\n\u003cp\u003eUsing the laryngeal mask as a guide to introduce a tracheal tube allows to avoid the direct laryngoscopy, may increase the intubation success rate reducing laryngoscopy-related adverse events.\u003c/p\u003e\n\n\u003cp\u003eIn a manikin simulating a term neonate, using a laryngeal mask led to a higher intubation success at the first attempt compared to direct laryngoscopy without extending the duration of the procedure or affecting the perceived difficulty. \u003c/p\u003e\n"},{"header":"INTRODUCTION","content":"\u003cp\u003eIntubating at birth is required in about 1% of neonates (\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e). However, health care providers have been progressively less exposed to neonatal intubation because of the implementation of less invasive procedures, such as continuous positive airway pressure and nasal intermittent positive pressure ventilation (\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e, \u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e). Pediatric residents and neonatology fellows may have a broad range of success rates (20\u0026ndash;70%) in performing neonatal intubation (\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e). The laryngoscopy is an invasive procedure which may be associated with direct trauma to the tissues and may lead to adverse reactions (\u003cspan additionalcitationids=\"CR6\" citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e). Adverse events have been frequently reported during neonatal intubation, including bradycardia, hypoxia, esophageal intubation, airway trauma, and intraventricular hemorrhage (\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e, \u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e, \u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eUsing the laryngeal mask as a guide to introduce a tracheal tube allows to avoid the direct laryngoscopy, may increase the intubation success rate reducing laryngoscopy-related adverse events, especially with less experienced personnel (\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e, \u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e). The 2022 recommendations from International Liaison Committee on Resuscitation (ILCOR) and the 2023 update of the American Heart Association Guidelines suggested that a laryngeal mask may be used as primary interface for administering positive pressure ventilation immediately after birth in newborn infants delivered at \u0026ge;\u0026thinsp;34 0/7 weeks\u0026rsquo; gestation (\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e, \u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e). Recently, neonatal sizes of laryngeal masks have become available.\u003c/p\u003e \u003cp\u003eThis trial aimed to compare intubation with laryngeal mask vs. direct laryngoscopy in a manikin simulating a term neonate. Moreover, the time of endotracheal tube positioning and participant\u0026rsquo;s opinion on difficulty of the procedure were investigated.\u003c/p\u003e"},{"header":"METHODS","content":"\u003cdiv id=\"Sec3\" class=\"Section2\"\u003e \u003ch2\u003eStudy design\u003c/h2\u003e \u003cp\u003eThis was a randomized, controlled, crossover (AB/BA) trial of intubation through a laryngeal mask vs. direct laryngoscopy in a manikin simulating a term infant (clinicaltrial.gov NCT06263790). The manikin trial was reviewed and approved by the Ethics Committees of the participating centers (Prot. 535n/AO/24 and G1.2024.0002222). All participants provided written informed consent.\u003c/p\u003e \u003c/div\u003e\n\u003ch3\u003eSetting\u003c/h3\u003e\n\u003cp\u003eThis simulation trial was conducted at the University Hospital of Padua (Italy) and the Fondazione Poliambulanza of Brescia (Italy) between 18th and 22nd March 2024. The scenario consisted of a term infant needing intubation (neonatal simulator manikin: Laerdal NewBorn Anne; Laerdal, Stavanger, Norway).\u003c/p\u003e\n\u003ch3\u003eParticipants\u003c/h3\u003e\n\u003cp\u003eLevel III neonatal intensive care unit (NICU) consultants and pediatric residents who had previous experience with intubating laryngeal airway and direct laryngoscopy were eligible to participate in the study. Refusal to participate was the only exclusion criteria.\u003c/p\u003e\n\u003ch3\u003eRandomization\u003c/h3\u003e\n\u003cp\u003eAll participants were randomly allocated to AB or BA arms in a 1:1 ratio. The randomization order was prepared using a computer-generated random assignment list in R 4.3 (R Foundation for Statistical Computing, Vienna, Austria) (\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e). Arm assignments were put in sequentially numbered, sealed, opaque envelopes.\u003c/p\u003e\n\u003ch3\u003eProcedures\u003c/h3\u003e\n\u003cp\u003eParticipants in AB arm were allocated to position the endotracheal tube in the manikin through a laryngeal mask (size 0.5 air-Qsp, Cookgas, Northridge, MI, USA), followed by the procedure using a standard direct laryngoscope with Miller blade size 1. Participants in BA arm were allocated to the inverse sequence. A washout period of 6 hours (one procedure in the morning and one in the afternoon) was included to reduce any carryover effect. An external observer recorded the study outcomes during each simulation.\u003c/p\u003e \u003cp\u003eWhen using the laryngeal mask, each participant was asked to i) place the laryngeal mask, ii) check the effective ventilation through the laryngeal mask, iii) insert a well‑lubricated endotracheal tube (size 3.5 mm), iv) check the effective ventilation through the endotracheal tube, v) insert the exchange removal stylet to stabilize the tracheal tube, vi) remove the laryngeal mask, and vii) start the positive pressure ventilation through the endotracheal tube (Fig.\u0026nbsp;\u003cspan refid=\"Fig1\" class=\"InternalRef\"\u003e1\u003c/span\u003e). When using the direct laryngoscope, each participant was asked to i) insert the laryngoscope, ii) visualize the glottis, iii) insert the endotracheal tube, and iv) start the positive pressure ventilation through the endotracheal tube (Fig.\u0026nbsp;\u003cspan refid=\"Fig1\" class=\"InternalRef\"\u003e1\u003c/span\u003e).\u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003cp\u003eAt the end of the first attempt, the correct positioning of the endotracheal tube was evaluated by the external observer using a laryngoscope; if the attempt failed, the procedure was repeated until achievement of the correct positioning. The total time of endotracheal tube positioning was calculated as the sum of the times of all attempts needed to achieve a correct positioning. At the end of each simulation, the participants were asked to score the insertion difficulty and the overall difficulty of the procedures using a Likert scale (from 1\u0026thinsp;=\u0026thinsp;not difficult to 5\u0026thinsp;=\u0026thinsp;very difficult).\u003c/p\u003e \u003cdiv id=\"Sec8\" class=\"Section2\"\u003e \u003ch2\u003eOutcome measures\u003c/h2\u003e \u003cp\u003eThe primary outcome measure was the success of the procedure at the first attempt, defined as the achievement of the correct positioning of the endotracheal tube in the trachea as assessed by the external observer. The secondary outcome measures included the total time of endotracheal tube positioning (calculated as the sum of the time of endotracheal tube positioning in all attempts, as the procedure was repeated in case of incorrect positioning) and participant\u0026rsquo;s opinion on insertion difficulty and overall difficulty of the procedures (assessed using a Likert scale).\u003c/p\u003e \u003c/div\u003e\n\u003ch3\u003eData collection\u003c/h3\u003e\n\u003cp\u003eRandomization sequence, participant\u0026rsquo;s demographics and experience, and data on outcome measures were recorded by a researcher who was not involved in the simulation. All data were collected in a dedicated data sheet and stored in a password-protected computer to ensure confidentiality before, during, and after the trial.\u003c/p\u003e\n\u003ch3\u003eMasking\u003c/h3\u003e\n\u003cp\u003eThe procedures did not allow the masking of the participants and the outcome assessors. However, the statistician who carried out the data analysis was masked to the treatment assignment.\u003c/p\u003e \u003cdiv id=\"Sec11\" class=\"Section2\"\u003e \u003ch2\u003eSample size\u003c/h2\u003e \u003cp\u003eThe literature did not offer any useful information on the primary outcome measure that could be used to inform the sample size calculation during the study design. Hence, we aimed to enroll all eligible subjects in the participating centers during the trial period (24 to 34 participants). In a crossover design, such sample sizes had the chance of detecting an effect size ranging from 20\u0026ndash;26% with 80% power and ranging from 23\u0026ndash;31% with 90% power. Sample size calculation was performed using R 4.3 (R Foundation for Statistical Computing, Vienna, Austria) (\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e).\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec12\" class=\"Section2\"\u003e \u003ch2\u003eStatistical analysis\u003c/h2\u003e \u003cp\u003eThe crossover design implemented an AB/BA scheme, which is uniform within sequences and periods (thus removing any period and sequence effects), and included a reasonable washout period to prevent any carryover effects. The categorical variables were summarized as absolute frequency and percentage, and the numerical variables as median and interquartile range (IQR). The binary outcome measure (correct positioning of the endotracheal tube in the trachea at the first attempt) was compared between the study arms using the McNemar test, and the effect size was reported as difference in proportion for paired data with 95% confidence interval (\u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e). The numerical outcome measures (total time of endotracheal tube positioning and participant's opinion were compared between the study arms using the quantile test, and the effect sizes were reported as median difference with bootstrap 95% confidence interval. All tests were 2-sided and a p-value less than 0.05 was considered statistically significant. Statistical analysis was performed using R 4.4 (R Foundation for Statistical Computing, Vienna, Austria) (\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e).\u003c/p\u003e \u003c/div\u003e"},{"header":"RESULTS","content":"\u003cp\u003eThe trial included 34 participants (10 males and 24 females) who were randomly assigned to the trial arms (Fig.\u0026nbsp;\u003cspan refid=\"Fig2\" class=\"InternalRef\"\u003e2\u003c/span\u003e). Median experience in neonatal intensive care was 3 years (IQR 1\u0026ndash;14). Experience in positioning a laryngeal mask in newborns was \u0026gt;\u0026thinsp;20 cases in four participants, 10\u0026ndash;20 cases in two participants, 5\u0026ndash;10 cases in three participants and \u0026lt;\u0026thinsp;5 cases in 25 participants. Experience in intubating newborns using a direct laryngoscope was \u0026gt;\u0026thinsp;20 cases in 16 participants, 10\u0026ndash;20 cases in three participants, 5\u0026ndash;10 cases in five participants and \u0026lt;\u0026thinsp;5 cases in 10 participants. Experience in positioning a laryngeal mask in neonatal manikins was \u0026gt;\u0026thinsp;20 cases in seven participants, 10\u0026ndash;20 cases in four participants, 5\u0026ndash;10 cases in six participants and \u0026lt;\u0026thinsp;5 cases in 17 participants. Experience in intubating neonatal manikins using a direct laryngoscope was \u0026gt;\u0026thinsp;20 cases in 11 participants, 10\u0026ndash;20 cases in eight participants, 5\u0026ndash;10 cases in five participants and \u0026lt;\u0026thinsp;5 cases in 10 participants.\u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003cp\u003eThe correct positioning of the endotracheal tube in the trachea was achieved at the first attempt by all participants with the laryngeal mask (100%) and 26 participants with the Miller laryngoscope (76%) (difference in percentage 24%, 95% confidence interval 5\u0026ndash;41%; p\u0026thinsp;=\u0026thinsp;0.008) (Table\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e).\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab1\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 1\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eOutcome measures\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"5\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eOutcome measures\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eIntubation via intubating laryngeal airway (n\u0026thinsp;=\u0026thinsp;34)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eIntubation via Miller laryngoscope\u003c/p\u003e \u003cp\u003e(n\u0026thinsp;=\u0026thinsp;34)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colspan=\"2\" nameend=\"c5\" namest=\"c4\"\u003e \u003cp\u003eComparison of intubating laryngeal airway vs. Miller laryngoscope\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePrimary outcome measure\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003ep-value (McNemar test)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c5\"\u003e \u003cp\u003eDifference in percentage for paired data (95% confidence interval)\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eCorrect positioning of the endotracheal tube in the trachea at the first attempt: n (%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e34 (100%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e26 (76%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0.008\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e24% (5\u0026ndash;41%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eSecondary outcome measure\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e\u003cb\u003ep-value (quantile test)\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e\u003cb\u003eMedian difference (bootstrap 95% confidence interval)\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eTotal time of endotracheal tube positioning, seconds: median (IQR)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e24 (19\u0026ndash;30)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e24 (19\u0026ndash;30)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0.99\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0 (-4 to 4)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eParticipant's opinion on insertion difficulty of the procedure, Likert scale (1\u0026thinsp;=\u0026thinsp;not difficult, 5\u0026thinsp;=\u0026thinsp;very difficult): median (IQR)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e1 (\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e2 (\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0.86\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e-1 (-1 to 0)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eParticipant's opinion on overall difficulty of the procedure, Likert scale (1\u0026thinsp;=\u0026thinsp;not difficult, 5\u0026thinsp;=\u0026thinsp;very difficult): median (IQR)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e2 (\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e2 (\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0.99\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e-0.5 (-1 to 0)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cp\u003eMedian time of endotracheal tube positioning was 24 seconds (IQR 19\u0026ndash;30) with both the laryngeal mask and the Miller laryngoscope (p\u0026thinsp;=\u0026thinsp;0.99) (Table\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e).\u003c/p\u003e \u003cp\u003e Participants\u0026rsquo; opinions about insertion difficulty and overall difficulty when intubating via the laryngeal mask or the Miller laryngoscope are displayed in Fig.\u0026nbsp;\u003cspan refid=\"Fig3\" class=\"InternalRef\"\u003e3\u003c/span\u003e. The comparison of the insertion difficulty (p\u0026thinsp;=\u0026thinsp;0.86) and the overall difficulty (p\u0026thinsp;=\u0026thinsp;0.99) did not provide any statistically significant difference between the laryngeal mask and the Miller laryngoscope (Table\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e).\u003c/p\u003e \u003cp\u003e \u003c/p\u003e"},{"header":"DISCUSSION","content":"\u003cp\u003eIn our trial, using an air-Qsp intubating laryngeal airway led to a higher intubation success at the first attempt compared to direct laryngoscopy in a manikin simulating a term neonate. Nonetheless, the time of endotracheal tube positioning and participant\u0026rsquo;s opinion on difficulty of the procedure were comparable between the two approaches.\u003c/p\u003e \u003cp\u003eIntubation is a required skill for all healthcare workers involved in the care of the newborns, but is difficult to acquire and has a long learning curve. Moreover, the reduced exposure to neonatal intubation impairs the chance of achieving and sustaining proficiency in this skill (\u003cspan additionalcitationids=\"CR3\" citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e, \u003cspan additionalcitationids=\"CR17\" citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e). Implementing strategies to enhance intubation success is likely to improve safety outcomes (\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e). Intubating through a laryngeal mask may offer some advantages over laryngoscopy including easiness of the procedure and avoidance of laryngoscopy-associated side effects (\u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e, \u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e). The intubating laryngeal mask (also known as the LMA-Fastrach) is a modified laryngeal mask airway which was developed to ease tracheal intubation either as blind or fiber-optic-assisted procedure (\u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e, \u003cspan citationid=\"CR23\" class=\"CitationRef\"\u003e23\u003c/span\u003e). The literature suggests easiness of use, short training, high success rate of positioning and adequate oxygenation during tracheal intubation attempts among the benefits of the intubating laryngeal airway, as well as less hemodynamic change and injury to teeth/lips compared to direct laryngoscopy in adults (\u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e). Nonetheless, potential drawbacks may involve esophageal intubation and damage to epiglottis, larynx or other tissues during the blind passage of the tracheal tube (\u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e). So far, previous studies were limited to adult and pediatric patients as intubating laryngeal airways for neonates have become available only recently. Our trial confirmed the higher intubation success using the air-Qsp intubating laryngeal airway compared to direct laryngoscopy in a manikin simulating a term neonate.\u003c/p\u003e \u003cp\u003ePositioning the endotracheal tube through the laryngeal mask may extend the duration of the procedure because it involves more actions due to the handling of two devices (insertion of the laryngeal mask, insertion of the endotracheal tube, and removal of the laryngeal mask). In our trial, using the air-Qsp intubating laryngeal airway did not delay the time of endotracheal tube positioning compared to direct laryngoscopy, and most procedures were performed within the recommended time of 30 seconds (\u003cspan citationid=\"CR24\" class=\"CitationRef\"\u003e24\u003c/span\u003e). We may speculate that positioning the endotracheal tube by using the laryngoscope benefited from the less actions involved but required some time to visualize the glottis.\u003c/p\u003e \u003cp\u003e Of note, the participants reported comparable insertion difficulty and overall difficulty of the procedure when using the laryngeal mask or the direct laryngoscope. Although the literature underlines the easiness of use of the laryngeal mask (\u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e, \u003cspan citationid=\"CR25\" class=\"CitationRef\"\u003e25\u003c/span\u003e), we believe that the heterogeneous experience of the participants with both devices in simulation settings and the higher experience with laryngoscopy in clinical practice might have levelled the perceived difficulty of the procedures.\u003c/p\u003e \u003cp\u003eThe strengths of the trial include the crossover design and the participation of health care providers with heterogeneous level of experience with the two approaches. Our findings may provide useful information to health care providers involved in neonatal airway management. However, the study also has some limitations that should be considered. The simulated scenario and the manikin provided a safe and low stress setting for the participants. Moreover, the simulation did not offer clinical information, hence the clinical implications of the findings could only be speculated. Finally, the generalizability of the results should be restricted to health care staff with similar background, although our participants reported a heterogeneous level of experience with laryngeal mask and direct laryngoscopy.\u003c/p\u003e"},{"header":"CONCLUSIONS","content":"\u003cp\u003eIn a term manikin model, positioning the endotracheal tube through the air-Qsp intubating laryngeal airway increased the success at the first attempt compared to direct laryngoscopy. Furthermore, using the intubating the laryngeal mask did not extend the duration of the procedure or affected the insertion difficulty and overall difficulty of the procedure as perceived by the operator. Further studies should confirm these findings in clinical settings.\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eEthics approval and consent to participate.\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe trial was reviewed and approved by the Ethics Committees of the participating centers (Prot. 535n/AO/24 and G1.2024.0002222). All participants provided written informed consent.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConsent for publication.\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eNot applicable.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAvailability of data and materials\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eAll data are available upon reasonable request by contacting the corresponding author.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eCompeting interests\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe authors declare that they have no competing interests.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eFunding\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eNo specific funding was used for the present study.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAuthors’ contributions\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eCM contributed tothe conceptualization, investigation, data curation, writing original draft, \u0026nbsp;and review \u0026amp; editing. FC analyzed the data and contributed tothe methodology, writing original draft andreview \u0026amp; editing. POcontributed to the methodology, conceptualization, investigation, writing, and review \u0026amp; editing; LE contributed to the investigation, data collection, writing, and review \u0026amp; editing; EP contributed to the investigation, data collection, writing, and review \u0026amp; editing; DT contributed to the conceptualization, methodology, supervision, writing, and review \u0026amp; editing; PEV contributed to the \u0026nbsp;conceptualization, methodology, supervision, writing, and review \u0026amp; editing.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAcknowledgements\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eWe would like to thank all participants in the study\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\n\u003cli\u003eMadar J, Roehr CC, Ainsworth S, Ersdal H, Morley C, R\u0026uuml;diger M, Sk\u0026aring;re C, Szczapa T, Te Pas A, Trevisanuto D, Urlesberger B, Wilkinson D, Wyllie JP. European Resuscitation Council Guidelines 2021: Newborn resuscitation and support of transition of infants at birth. Resuscitation 2021;161:291-326.\u003c/li\u003e\n\u003cli\u003eLeone TA, Rich W, Finer NN. Neonatal intubation: success of pediatric trainees. J Pediatr 2005;146:638-41.\u003c/li\u003e\n\u003cli\u003ePinheiro JMB. Neonatal Airway Management. Children (Basel). 2024;11(1):82.\u003c/li\u003e\n\u003cli\u003eSawyer T, Foglia E, Hatch LD, Moussa A, Ades A, Johnston L, Nishisaki A. Improving neonatal intubation safety: A journey of a thousand miles. J Neonatal Perinatal Med 2017;10:125-31.\u003c/li\u003e\n\u003cli\u003eHassan HG, El-Sharkawy TY, Renck H, Mansour G, Fouda A. Hemodynamic and catecholamine responses to laryngoscopy with vs. without endotracheal intubation. Acta Anaesthesiol Scand 1991;35:442-7.\u003c/li\u003e\n\u003cli\u003eFoglia EE, Ades A, Sawyer T, Glass KM, Singh N, Jung P, Quek BH, Johnston LC, Barry J, Zenge J, Moussa A, Kim JH, DeMeo SD, Napolitano N, Nadkarni V, Nishisaki A; NEAR4NEOS Investigators. Neonatal Intubation Practice and Outcomes: An International Registry Study. Pediatrics 2019;143:e20180902. \u003c/li\u003e\n\u003cli\u003eInoue A, Okamoto H, Hifumi T, Goto T, Hagiwara Y, Watase H, Hasegawa K; Japanese Emergency Medicine Network Investigators. The incidence of post-intubation hypertension and association with repeated intubation attempts in the emergency department. PLoS One. 2019;14(2):e0212170. \u003c/li\u003e\n\u003cli\u003eHatch LD, Grubb PH, Lea AS, Walsh WF, Markham MH, Whitney GM, Slaughter JC, Stark AR, Ely EW. Endotracheal Intubation in Neonates: A Prospective Study of Adverse Safety Events in 162 Infants. J Pediatr 2016;168:62-66.e6.\u003c/li\u003e\n\u003cli\u003eSauer CW, Kong JY, Vaucher YE, Finer N, Proudfoot JA, Boutin MA, Leone TA. Intubation Attempts Increase the Risk for Severe Intraventricular Hemorrhage in Preterm Infants-A Retrospective Cohort Study J Pediatr. 2016;177:108-13.\u003c/li\u003e\n\u003cli\u003eGerstein NS, Braude DA, Hung O, Sanders JC, Murphy MF. The Fastrach Intubating Laryngeal Mask Airway: an overview and update. Can J Anaesth. 2010;57(6):588-601. \u003c/li\u003e\n\u003cli\u003eLee DH, Stang J, Reardon RF, Martel ML, Driver BE, Braude DA. Rapid Sequence Airway with the Intubating Laryngeal Mask in the Emergency Department. J Emerg Med. 2021;61(5):550-557. \u003c/li\u003e\n\u003cli\u003eYamada NK, McKinlay CJD, Quek BH, Rabi Y, Costa-Nobre DT, de Almeida MF, Davis PG, El-Naggar W, Fabres JG, Fawke J, Foglia EE, Guinsburg R, Hosono S, Isayama T, Kapadia VS, Kawakami MD, Kim HS, Lee H, Liley HG, Madar RJ, Nakwa FL, Perlman JM, Roehr CC, R\u0026uuml;diger M, Schm\u0026ouml;lzer GM, Sugiura T, Trevisanuto D, Wyckoff MH, Wyllie JP, Weiner GM. Supraglottic airways for neonatal resuscitation (NLS#618/5340 [Internet] Brussels, Belgium. International Liaison Committee on Resuscitation (ILCOR) Neonatal Life Support Task Force, Available from http://ilcor.org\u003c/li\u003e\n\u003cli\u003eYamada NK, Szyld E, Strand ML, Finan E, Illuzzi JL, Kamath-Rayne BD, Kapadia VS, Niermeyer S, Schm\u0026ouml;lzer GM, Williams A, Weiner GM, Wyckoff MH, Lee HC; American Heart Association and American Academy of Pediatrics. 2023 American Heart Association and American Academy of Pediatrics Focused Update on Neonatal Resuscitation: An Update to the American Heart Association Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. Circulation. 2024;149(1):e157-e166..\u003c/li\u003e\n\u003cli\u003eR Core Team R (2024). A language and environment for statistical computing. R Foundation for Statistical Computing, Vienna, Austria.\u003c/li\u003e\n\u003cli\u003eFay MP, Lumbard K. Confidence Intervals for Difference in Proportions for Matched Pairs Compatible with Exact McNemars or Sign Tests. Statistics in Medicine. 2021;40(5):1147-115.\u003c/li\u003e\n\u003cli\u003eDoglioni N, Cavallin F, Zanardo V, Trevisanuto D. Intubation training in neonatal patients: a review of one trainee\u0026apos;s first 150 procedures. J Matern Fetal Neonatal Med. 2012;25(8):1302-4. \u003c/li\u003e\n\u003cli\u003eHaubner LY, Barry JS, Johnston LC, Soghier L, Tatum PM, Kessler D, Downes K, Auerbach M. Neonatal intubation performance: room for improvement in tertiary neonatal intensive care units. Resuscitation. 2013;84(10):1359-64. \u003c/li\u003e\n\u003cli\u003eUchinami Y, Fujita N, Ando T, Mizunoya K, Hoshino K, Yokota I, Morimoto Y. The relationship between years of anesthesia experience and first-time intubation success rate with direct laryngoscope and video laryngoscope in infants: a retrospective observational study. J Anesth. 2022;36(6):707-714.\u003c/li\u003e\n\u003cli\u003eHerrick HM, O\u0026rsquo;Reilly MA, Foglia EE. Success rates and adverse events during neonatal intubation: Lessons learned from an international registry. Semin Fetal Neonatal Med. 2023 Oct 1;28(5):101482\u003c/li\u003e\n\u003cli\u003eCaponas G. Intubating laryngeal mask airway. Anaesth Intensive Care. 2002;30(5):551-69.\u003c/li\u003e\n\u003cli\u003eYoung B. The intubating laryngeal-mask airway may be an ideal device for airway control in the rural trauma patient. Am J Emerg Med. 2003;21(1):80-5.\u003c/li\u003e\n\u003cli\u003eBrain AI, Verghese C, Addy EV, Kapila A. The intubating laryngeal mask. I: Development of a new device for intubationof the trachea. Br J Anaesth 1997; 79:699-703.\u003c/li\u003e\n\u003cli\u003eFerson DZ, Brimacombe J, Brain AI, Verghese C. The intubating laryngeal mask airway. Int Anesthesiol Clin 1998;36:183-209.\u003c/li\u003e\n\u003cli\u003eAmerican Academy of Pediatrics and American Heart Association. Textbook of Neonatal Resuscitation. Ed. Gary M. Weiner, Jeanette Zaichkin. 8th Edition, 2021.\u003c/li\u003e\n\u003cli\u003eTrevisanuto D, Micaglio M, Ferrarese P, Zanardo V. The laryngeal mask airway: potential applications in neonates. Arch Dis Child Fetal Neonatal Ed. 2004;89(6):F485-9.\u003c/li\u003e\n\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":false,"highlight":"","institution":"","isAcceptedByJournal":true,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":true,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"italian-journal-of-pediatrics","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"itjp","sideBox":"Learn more about [Italian Journal of Pediatrics](http://ijponline.biomedcentral.com)","snPcode":"","submissionUrl":"https://www.editorialmanager.com/ITJP/default.aspx","title":"Italian Journal of Pediatrics","twitterHandle":"@BioMedCentral","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"em","reportingPortfolio":"BMC/SO AJ","inReviewEnabled":true,"inReviewRevisionsEnabled":true},"keywords":"direct laryngoscopy, endotracheal intubation, laryngeal mask, manikin, term infant","lastPublishedDoi":"10.21203/rs.3.rs-6047892/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-6047892/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cstrong\u003eBackground:\u003c/strong\u003e We aimed to compare endotracheal intubation through a laryngeal mask vs. using a direct laryngoscope in a manikin simulating a term infant.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eMethods: \u003c/strong\u003eA randomized, controlled, crossover (AB/BA) trial of intubation through a laryngeal mask vs. a direct laryngoscope in a manikin simulating a term infant. Thirty-four tertiary neonatal intensive care unit consultants and pediatric residents who had previous experience with intubating laryngeal airway and direct laryngoscopy participated. The primary outcome measure was the success of the procedure at the first attempt. The secondary outcome measures included the total time of endotracheal tube positioning and participant’s opinion on insertion difficulty and overall difficulty.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eResults:\u003c/strong\u003e Success at first attempt was 34/34 with the laryngeal mask (100%) and 26/34 with thedirect laryngoscope (76%) (difference in percentage 24%, 95% confidence interval 5% to 41%; p=0.008).\u003c/p\u003e\n\u003cp\u003eMedian time of endotracheal tube positioning was 24 seconds (IQR 19-30) with both devices (p=0.86). Insertion difficulty (p=0.96) and overall difficulty (p=0.99) were not statistically different between the devices.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConclusions: \u003c/strong\u003eIn a term infant manikin model, positioning the endotracheal tube through the laryngeal mask increased the success at the first attempt compared to direct laryngoscopy, without extending the duration of the procedure or affecting the perceived difficulty.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eRegistration:\u003c/strong\u003e clinicaltrial.gov NCT06263790. Registered 16 February 2024, https://clinicaltrials.gov/study/NCT06263790\u003c/p\u003e","manuscriptTitle":"Intubating laryngeal airway vs. direct laryngoscope: a crossover randomized controlled neonatal manikin trial","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2025-04-14 23:15:35","doi":"10.21203/rs.3.rs-6047892/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"reviewerAgreed","content":"","date":"2025-04-05T09:30:42+00:00","index":0,"fulltext":""},{"type":"reviewersInvited","content":"","date":"2025-04-04T16:50:07+00:00","index":"","fulltext":""},{"type":"submitted","content":"Italian Journal of Pediatrics","date":"2025-03-31T11:39:36+00:00","index":"","fulltext":""},{"type":"editorAssigned","content":"","date":"2025-03-31T09:04:23+00:00","index":"","fulltext":""}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"italian-journal-of-pediatrics","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"itjp","sideBox":"Learn more about [Italian Journal of Pediatrics](http://ijponline.biomedcentral.com)","snPcode":"","submissionUrl":"https://www.editorialmanager.com/ITJP/default.aspx","title":"Italian Journal of Pediatrics","twitterHandle":"@BioMedCentral","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"em","reportingPortfolio":"BMC/SO AJ","inReviewEnabled":true,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"31f4b8fa-587b-4076-a7bd-015e902c9bf0","owner":[],"postedDate":"April 14th, 2025","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"published-in-journal","subjectAreas":[],"tags":[],"updatedAt":"2025-06-23T16:03:40+00:00","versionOfRecord":{"articleIdentity":"rs-6047892","link":"https://doi.org/10.1186/s13052-025-01988-8","journal":{"identity":"italian-journal-of-pediatrics","isVorOnly":false,"title":"Italian Journal of Pediatrics"},"publishedOn":"2025-06-20 15:57:00","publishedOnDateReadable":"June 20th, 2025"},"versionCreatedAt":"2025-04-14 23:15:35","video":"","vorDoi":"10.1186/s13052-025-01988-8","vorDoiUrl":"https://doi.org/10.1186/s13052-025-01988-8","workflowStages":[]},"version":"v1","identity":"rs-6047892","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-6047892","identity":"rs-6047892","version":["v1"]},"buildId":"XKTyCvWXoU3ODBz1xrDgd","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}