Core Warming in COVID-19 Patients Undergoing Mechanical Ventilation

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Covid19

Intervention / Treatment
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* Device: Core Warming
* Other: Standard of Care


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Core warming<br>Patients receive the Attune Medical Esophageal Heat Transfer Device (EnsoETM) and undergo core warming | Device: Core Warming<br>* Esophageal heat transfer device will be set to 42°C temperature after initial placement, and maintained at 42°C for the duration of treatment.<br>* Other names: EnsoETM;|
| Active Comparator: Standard of Care<br>Patients receive standard temperature management and treatment | Other: Standard of Care<br>* Standard temperature management and treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PaO2/FiO2 Ratio | 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. | 0, 24, 48, and 72 hours after initiation of core warming | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cycle Threshold at 72-hours | Determine the change cycle threshold after implementation of core warming of ventilated patients, and compare this change to patients undergoing standard care. | 72 hours after initiation of core warming | 
| Ventilator-Free Days | Measure the impact of core warming on duration of mechanical ventilation. | Initiation of Core Warming Until Patient Weaned Off Mechanical Ventilation | 
| 30-Day Mortality | Determine impact of core warming on patient mortality. | 30 days after initiation of core warming |