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 transnasal temperature-modulating device (tnTMD) and surface cooling temperature-modulating devices (sTMDs) during the first 24 h 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 the following: core body temperature (every 2 h), bedside shivering assessment scale (BSAS) score (every 2 h), and administration of antishivering medication for a BSAS score > 1. Time to normothermia (≤ 37.5 °C), as well as temperature burden > 37.5 °C (°C × h), were compared between groups using Student’s t-test for mean differences. The proportion of patients requiring interventions, as well as the number of interventions per patient, was compared using the χ2 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, body surface area = 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 °C (tnTMD: 1.8 ± 1.5 h vs. sTMD: 2.9 ± 1.4 h, p = 0.1), or temperature burden > 37.5 (tnTMD: − 0.4 ± 1.13 °C × h vs. sTMD median [IQR]: − 0.57 ± 0.58 °C × h, p = 0.67). The number of tnTMD patients who received pharmacologic shivering interventions was lower than the number of 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).
Conclusions
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.
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Funding
This study was funded in part by the Maryland Industrial Partnerships program and CoolTech Corp.
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SA contributed to concept, design, acquisition of data, and drafting of the manuscript. MA contributed to the acquisition of data and critical revision of the manuscript for intellectual content. LFT contributed to acquisition of data, analysis and interpretation of data, and critical revision of the manuscript for intellectual content. HTripathi contributed to acquisition of data and analysis and interpretation of data. HTandri contributed to analysis and interpretation of data and critical revision of the manuscript for intellectual content. JJC contributed to analysis and interpretation of data and critical revision of the manuscript for intellectual content. HAC contributed to analysis and interpretation of data and critical revision of the manuscript for intellectual content. NB contributed to concept, design, analysis and interpretation of data, drafting of the manuscript, statistical analysis, obtaining funding, and administrative, technical, and material support supervision.
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All data collection for retrospective analysis of participants undergoing sTMD was approved by the Institutional Review Board at the University of Maryland School of Medicine. Participants undergoing cooling with tnTMD were enrolled in a study that was approved at each site by the institutional review board and by the US Food and Drug Administration through an investigational device exemption and registered on ClinicalTrials.gov (NCT03360656).
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Arnold, S., Armahizer, M., Torres, L.F. et al. Minimizing Shivering During Targeted Normothermia: Comparison Between Novel Transnasal and Surface Temperature-Modulating Devices. Neurocrit Care 39, 639–645 (2023). https://doi.org/10.1007/s12028-023-01793-3
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DOI: https://doi.org/10.1007/s12028-023-01793-3