Status:

COMPLETED

Core Warming in COVID-19 Patients Undergoing Mechanical Ventilation

Lead Sponsor:

Sharp HealthCare

Collaborating Sponsors:

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

Conditions:

Covid19

Eligibility:

All Genders

18+ years

Phase:

NA

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, an...

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 ...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

August 19 2020

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

February 28 2022

Estimated Enrollment :

20 Patients enrolled

Trial Details

Trial ID

NCT04494867

Start Date

August 19 2020

End Date

February 28 2022

Last Update

March 9 2023

Active Locations (1)

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1

Sharp Memorial Hospital

San Diego, California, United States, 92123