NCT04494867

Core Warming in COVID-19 Patients Undergoing Mechanical Ventilation

Core Warming of COVID-19 Patients Undergoing Mechanical Ventilation: a Randomized, Single Center Pilot Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Sharp HealthCare · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Covid19

Interventions

Type	Name	Description
DEVICE	Core Warming	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	Standard of Care	Standard temperature management and treatment

Timeline

• Start date: 2020-08-19
• Primary completion: 2022-02-28
• Completion: 2022-02-28
• First posted: 2020-07-31
• Last updated: 2023-03-09
• Results posted: 2023-03-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study