Core Warming in COVID-19 Patients Undergoing Mechanical Ventilation

Sharp HealthCare20 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Covid19

Interventions

Core WarmingDEVICE

Esophageal heat transfer device will be set to 42°C temperature after initial placement, and maintained at 42°C for the duration of treatment.

Standard of CareOTHER

Standard temperature management and treatment

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Sharp Memorial Hospital

San Diego, California, United States

Outcomes

Primary Outcomes

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.

Time frame: 0, 24, 48, and 72 hours after initiation of core warming

Secondary Outcomes

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.

Time frame: 72 hours after initiation of core warming

Ventilator-Free Days

Measure the impact of core warming on duration of mechanical ventilation.

Time frame: Initiation of Core Warming Until Patient Weaned Off Mechanical Ventilation

30-Day Mortality

Determine impact of core warming on patient mortality.

Time frame: 30 days after initiation of core warming

Data from ClinicalTrials.gov

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