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0 0.5 1 1.5 2+ Mortality -11% Improvement Relative Risk Mortality, day 30 26% Thermotherapy  Bonfanti et al.  VENTILATED PATIENTS  RCT Is late treatment with thermotherapy beneficial for COVID-19? RCT 19 patients in the USA (September 2020 - February 2022) Trial underpowered to detect differences c19early.org Bonfanti et al., Therapeutic Hypotherm.., Nov 2023 Favors thermotherapy Favors control

Core Warming of Coronavirus Disease 2019 Patients Undergoing Mechanical Ventilation: A Pilot Study

Bonfanti et al., Therapeutic Hypothermia and Temperature Management, doi:10.1089/ther.2023.0030, NCT04494867
Nov 2023  
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42nd treatment shown to reduce risk in December 2023
 
*, now known with p = 0.026 from 4 studies.
Lower risk for recovery.
No treatment is 100% effective. Protocols combine complementary and synergistic treatments. * >10% efficacy in meta analysis with ≥3 clinical studies.
4,000+ studies for 60+ treatments. c19early.org
RCT of 19 mechanically ventilated COVID-19 patients randomized to standard care or core warming with an esophageal heat exchanger to target 39.8C for 72 hours. The core warming group reached higher temperatures but had similar outcomes including PaO2/FiO2 ratios, viral clearance, duration of ventilation, and mortality. Baseline SOFA and PaO2/FiO2 indicate higher severity in the treatment group. The results suggest that core warming is feasible and safe but a larger trial with a multimodal warming strategy may be needed to optimize time to target temperature and further evaluate effects.
This study is excluded in meta analysis: very late treatment, mechanically ventilated patients, baseline SOFA and PaO2/FiO2 show higher severity in the treatment group; very late stage, ventilated patients.
risk of death, 11.1% higher, RR 1.11, p = 1.00, treatment 4 of 9 (44.4%), control 4 of 10 (40.0%).
risk of death, 25.9% lower, RR 0.74, p = 1.00, treatment 2 of 9 (22.2%), control 3 of 10 (30.0%), NNT 13, day 30.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Bonfanti et al., 30 Nov 2023, Randomized Controlled Trial, USA, peer-reviewed, mean age 60.5, 8 authors, study period September 2020 - February 2022, average treatment delay 9.4 days, trial NCT04494867 (history).
This PaperThermotherapyAll
Core Warming of Coronavirus Disease 2019 Patients Undergoing Mechanical Ventilation: A Pilot Study
MD Nathaniel P Bonfanti, MD, MS Nicholas M Mohr, MD David C Willms, MD, MS Roger J Bedimo, MD Emily Gundert, MD Kristina L Goff, MD Erik B Kulstad, MD Anne M Drewry
Therapeutic Hypothermia and Temperature Management, doi:10.1089/ther.2023.0030
Fever is a recognized protective factor in patients with sepsis, and growing data suggest beneficial effects on outcomes in sepsis with elevated temperature, with a recent pilot randomized controlled trial (RCT) showing lower mortality by warming afebrile sepsis patients in the intensive care unit (ICU). The objective of this prospective single-site RCT was to determine if core warming improves respiratory physiology of mechanically ventilated patients with coronavirus disease 2019 (COVID-19), allowing earlier weaning from ventilation, and greater overall survival. A total of 19 patients with mean age of 60.5 (-12.5) years, 37% female, mean weight 95.1 (-18.6) kg, and mean body mass index 34.5 (-5.9) kg/m 2 with COVID-19 requiring mechanical ventilation were enrolled from September 2020 to February 2022. Patients were randomized 1:1 to standard of care or to receive core warming for 72 hours through an esophageal heat exchanger commonly utilized in critical care and surgical patients. The maximum target temperature was 39.8°C. A total of 10 patients received usual care and 9 patients received esophageal core warming. After 72 hours of warming, the ratio of arterial oxygen partial pressure to fractional inspired oxygen (PaO2/FiO2) ratios were 197 (-32) and 134 (-13.4), cycle thresholds were 30.8 (-6.4) and 31.4 (-3.2), ICU mortalities were 40% and 44%, 30-day mortalities were 30% and 22%, and mean 30-day ventilator-free days were 11.9 (-12.6) and 6.8 (-10.2) for standard of care and warmed patients, respectively ( p = NS). This pilot study suggests that core warming of patients with COVID-19 undergoing mechanical ventilation is feasible and appears safe. Optimizing time to achieve febrile-range temperature may require a multimodal temperature management strategy to further evaluate effects on outcome. ClinicalTrials.
Authors' Contributions Writing-original draft, review, and editing by N.P.B. Methodology, data curation, and formal analysis by N.M.M.
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Late treatment
is less effective
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