Skip to main content
OpenTrials
Completed

NCT Number: NCT04494867

Core Warming in COVID-19 Patients Undergoing Mechanical Ventilation

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sharp Memorial Hospital

San Diego, California, 92123, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Core Warming

Device

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 of care

Other

Standard temperature management and treatment

Primary outcomes

  1. PaO2/FiO2 Ratio

    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.

Secondary outcomes

  1. Cycle Threshold at 72-hours

    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.

  2. Ventilator-Free Days

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

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

  3. 30-Day Mortality

    Time frame: 30 days after initiation of core warming

    Determine impact of core warming on patient mortality.

Sponsors and collaborators

Lead sponsor

Sharp HealthCare

Other

Collaborators

  • Advanced Cooling Therapy, Inc., d/b/a Attune Medical

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jul 31, 2020
Registry last updated
Mar 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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.

Published trials that share one or more normalized conditions with this study.