Core Warming in COVID-19 Patients Undergoing Mechanical Ventilation

Not Applicable

Completed

• Conditions: Covid19
• Interventions: Other: Standard of Care; Device: Core Warming

• Registration Number: NCT04494867
• Lead Sponsor: Sharp HealthCare

Brief 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.

Study Timeline

• Study First Submitted: 2020-07-29
• Study First Submitted QC: 2020-07-29
• Study First Posted: 2020-07-31
• Study Start: 2020-08-19
• Primary Completion: 2022-02-28
• Study Completion: 2022-02-28
• Status Verified: 2023-02
• Results First Submitted: 2023-02-08
• Results First Submitted QC: 2023-02-08
• Last Update Submitted: 2023-02-08
• Results First Posted: 2023-03-09
• Last Update Posted: 2023-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard of Care	Standard of Care	Patients receive standard temperature management and treatment
Core warming	Core Warming	Patients receive the Attune Medical Esophageal Heat Transfer Device (EnsoETM) and undergo core warming

Primary Outcome Measures

Name	Time	Method
PaO2/FiO2 Ratio	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.

Secondary Outcome Measures

Name	Time	Method
Ventilator-Free Days	Initiation of Core Warming Until Patient Weaned Off Mechanical Ventilation	Measure the impact of core warming on duration of mechanical ventilation.
Cycle Threshold at 72-hours	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.
30-Day Mortality	30 days after initiation of core warming	Determine impact of core warming on patient mortality.

Trial Locations

Locations (1)

Sharp Memorial Hospital; 🇺🇸 San Diego, California, United States