Sharp Memorial Hospital
San Diego, California, 92123, United States
NCT Number: NCT04494867
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
San Diego, California, 92123, United States
This is a small scale pilot study to evaluate if core warming improves respiratory physiology of mechanically ventilated patients with COVID-19, allowing earlier weaning from ventilation, and greater overall survival. This prospective, randomized study will include 20 patients diagnosed with COVID-19, and undergoing mechanical ventilation for the treatment of respiratory failure. Patients will be randomized in a 1:1 fashion with 10 patients (Group A) randomized to undergo core warming, and the other 10 patients (Group B) serving as the control group who will not have the ensoETM device used. Patients randomized to Group A will have core warming initiated in the ICU or other clinical environment in which they are being treated after enrollment and provision of informed consent from appropriate surrogate or legally authorized representative.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Esophageal heat transfer device will be set to 42°C temperature after initial placement, and maintained at 42°C for the duration of treatment.
Other names: EnsoETM
Standard temperature management and treatment
Time frame: 0, 24, 48, and 72 hours after initiation of core warming
Determine the change in PaO2/FiO2 ratio at 0, 24, 48, and 72 hours after implementation of core warming of ventilated patients, and compare this change to patients undergoing standard care.
Time frame: 72 hours after initiation of core warming
Determine the change cycle threshold after implementation of core warming of ventilated patients, and compare this change to patients undergoing standard care.
Time frame: Initiation of Core Warming Until Patient Weaned Off Mechanical Ventilation
Measure the impact of core warming on duration of mechanical ventilation.
Time frame: 30 days after initiation of core warming
Determine impact of core warming on patient mortality.
Sharp HealthCare
Other
Core Warming of COVID-19 Patients Undergoing Mechanical Ventilation: a Randomized, Single Center Pilot Study
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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