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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Core warming 		Patients receive the Attune Medical Esophageal Heat Transfer Device (EnsoETM) and undergo core warming
  • Device: Core Warming
    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
Active Comparator
Standard of Care 		Patients receive standard temperature management and treatment
  • Other: Standard of Care
    Standard temperature management and treatment

Recruiting Locations

More Details

NCT ID
NCT04494867
Status
Completed
Sponsor
Sharp HealthCare

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.