N/A
N=20
Core Warming in COVID-19 Patients Undergoing Mechanical Ventilation
Covid19
Bottom Line
View on ClinicalTrials.gov: NCT04494867 ↗Enrolled (actual)
20
Serious AEs
15.8%
Results posted
Mar 2023
Primary outcome: Primary: PaO2/FiO2 Ratio — 119.1435; 164.789; 130.0138; 154.9758 Ratio
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Core Warming (Device); Standard of Care (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Sharp HealthCare
- Primary completion
- Feb 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY PaO2/FiO2 Ratio |
119.1435; 164.789; 130.0138; 154.9758; 158.2389; 196.7167 | — |
| SECONDARY Cycle Threshold at 72-hours |
31.4; 30.8 | — |
| SECONDARY Ventilator-Free Days |
6.8; 11.9 | — |
| SECONDARY 30-Day Mortality |
2; 4 | — |
Summary
The purpose of the proposed pilot study is to determine if core warming improves respiratory physiology of mechanically ventilated patients with COVID-19, allowing earlier weaning from ventilation, and greater overall survival.
Eligibility Criteria
Inclusion Criteria
- Patients above the age of 18 years old.
- Patients with a diagnosis of COVID-19 on mechanical ventilation.
- Patient maximum baseline temperature (within previous 12 hours) < 38.3°C.
- Patients must have a surrogate or legally authorized representative able to understand and critically review the informed consent form.
Exclusion Criteria
- Patients without surrogate or legally authorized representative able to provide informed consent.
- Patients with contraindication to core warming using an esophageal core warming device.
- Patients known to be pregnant.
- Patients with <40 kg of body mass.
- Patients with DNR status.
- Patients with acute stroke, post-cardiac arrest, or multiple sclerosis.
Data sourced from ClinicalTrials.gov (NCT04494867). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.