Impact of prior SARS-CoV-2 infection on perioperative cardiac, pulmonary and neurocognitive complications in elderly patients: study protocol for an observative cohort study

Background Postoperative delirium is considered a serious complication in elderly patients. Elderly patients often suffer from several concomitant diseases. The reduced physical condition can increase the risk of cardiac, pulmonary and neurocognitive complications during and after surgery. SARS-CoV-2 infection primarily affects the respiratory tract but can also damage other organ systems such as the heart and brain. Given the wide range of pulmonary, cardiac and neurocognitive complications caused by SARS-CoV-2, these risks must be given special consideration during planned surgical procedures. Both surgical procedures and anesthesia are risk factors for postoperative complications in themselves. The specific impact of prior SARS-CoV-2 infection on perioperative complications in elderly patients has not been sufficiently researched. The aim of this study is to understand how a previous SARS-CoV-2 infection influences the occurrence of perioperative complications.

In this case-control study, the data of patients over 60 years of age undergoing elective surgery are analyzed. Subjects are divided into two groups based on their SARS-CoV-2 infection status: those with a documented previous infection and those without. Confirmation of infection will be based on written evidence and anamnestic information. The primary endpoint of the examination is the occurrence of delirium within the first five postoperative days. In addition, further cardiac, pulmonary and neurocognitive complications are recorded in the perioperative period. The occurrence of postoperative delirium is recorded during the daily ward round in the first five days after the operation. The 3DCAM test and the 4AT are used for this purpose. In addition, the CAM-ICU will be used in the intensive care unit. The recruitment will include 266 patients. Statistical analyses will be performed to determine the correlation between a previous SARS-CoV-2 infection and the observed clinical outcomes.

The results of this study will provide new insights into the impact of prior SARS-CoV-2 infection on perioperative complications in elderly patients undergoing elective surgery. Trial registration: Deutsches Register Klinischer Studien DRKS00034861 Competing Interest Statement The authors have declared no competing interest. Funding Statement The study is financed from own funds. Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: This study has been approved by the Ethics Committee of the Ludwig-Maximilians- Universität München (LMU Munich). The ethics committee reviewed and approved the study protocol under the reference number 23-0552. Informed written consent was obtained from all participants involved in the study. I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes Abbreviations - 3DCAM - 3-dimensional confusion assessment method - 4AT - alertness, attention, acute change and abbreviated mental test-4 - ACE2 - angiotensin-converting-enzyme-2-receptors - ALI - acute lung injury - ARDS - acute respiratory distress syndrome - ASA - American Society of Anesthesiologists’ Physical Status - BDSG - Bundesdatenschutzgesetz (Federal Data Protection Act) - BMI - body-mass index - CARDS - COVID-19-associated Acute Respiratory Distress Syndrome - COVID-19 - coronavirus disease 2019 - CRP - C-reactive protein - eCRF - electronic Case Report Form - FiO2 - fraction of inspired oxygen - GCP - good clinical practice - GI - gastrointestinal - ICU - intensive care unit - KAS - Krankenhaus-Informations-und Verwaltungssystem (hospital information and administration system) - LMU - Ludwig-Maximilians-Universität - MAP - mean Arterial Pressure - MOCA - Montreal Cognitive Assessment - NarkoPrämed - Narkose Prämedikation (anesthesia premedication) - NRS - numerical Rating Scale - PaO2 - partial pressure of arterial oxygen - PaCO2 - partial pressure of arterial carbon dioxide - PCPF - Post-COVID pulmonary fibrosis - PCR - polymerase chain reaction test - PEEP - positive end-expiratory pressure - Pmean - mean pressure - PONV - postoperative nausea and vomiting - Ppeak - peak pressure - REDCap - research electronic data capture - RKI - Robert Koch Institut - SARS-CoV-2 - severe acute respiratory syndrome coronavirus 2 - SpO2 - oxygen saturatios - SSRI - selective serotonin reuptake inhibitor - TIVA - total intravenous anesthesia - VT - tidal volume