Minimizing shivering during targeted normothermia: Comparison between a Novel Trans-Nasal and Surface Temperature Modulating Devices

Abstract Background: Shivering is a common adverse effect of achieving and maintaining normothermia in neurocritical care patients. We compared the burden of shivering and shivering-related interventions between a novel trans-nasal temperature modulating device(tnTMD) and surface cooling temperature modulating devices(sTMDs) during the first 24 hours of targeted normothermia in mechanically ventilated febrile neurocritical care patients. Methods: This is a case: control study controlling for factors that impact shiver burden: age, sex, body surface area. All patients underwent transnasal cooling (COOLSTAT, KeyTech, Inc) as part of an ongoing multicenter clinical trial(NCT03360656). Patients undergoing treatment with sTMDs were selected from consecutively treated patients during the same time-period. Data collected included: core body temperature (every 2 hours), bedside shivering assessment scale(BSAS) score (every 2 hours), and administration of anti-shivering medication for BSAS>1.Time to normothermia(37.5 C(C*hr) were compared between groups using student’s t-test for mean differences. Proportion of patients requiring interventions as well as number of interventions per patient were compared using Chi-Square test. Significance was determined based on a P value < 0.05. Results: There were 10 tnTMD patients and 30 sTMD patients included in the analysis (mean age: 62+/-4, 30% women, BSA = 1.97+/-0.25). There were no differences between groups in temperature at cooling initiation (tnTMD: 38.5+/-0.2 C vs sTMD: 38.7+/-0.5 C, P=0.3), time to 37.5 (tnTMD:: -0.4 +/- 1.13 C*hr vs. sTMD median (IQR): -0.57 +/- 0.58 C*hr, P=0.67). The number of tnTMD patients who received pharmacologic shivering interventions was lower than the controls (20%vs.67%,p=0.01). tnTMD patients also had fewer shivering interventions per patient (0 (range: 0-3)vs.4(range: 0 – 23 ), p<0.001). Conclusion: A transnasal cooling approach achieved similar time to normothermia and temperature burden with less shivering than surface cooling. This approach may be a feasible option to consider for mechanically ventilated febrile neurocritical care patients. Trial registration: Clinical trials.gov: NCT03360656. Registered December 4, 2017. https://clinicaltrials.gov/ct2/show/NCT03360656