COVID Core Warming: a Randomized Controlled Pilot Study

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2020

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.

Interventions

  • 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: Standard of Care
    • Standard temperature management and treatment

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

Primary Measures

  • Viral Load Measurement
    • Time Frame: 72 hours after initiation of core warming
    • Determine the change in viral load measured in tracheal aspirate after implementation of core warming of ventilated patients, and compare this change to patients undergoing standard care.

Secondary Measures

  • 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.
  • Duration of mechanical ventilation
    • Time Frame: 72 hours after initiation of core warming
    • Measure the impact of core warming on duration of mechanical ventilation.
  • Mortality
    • Time Frame: 30 days
    • Determine impact of core warming on patient mortality.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Advanced Cooling Therapy, Inc., d/b/a Attune Medical
  • Collaborator
    • Sharp HealthCare
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • David Willms, MD, Principal Investigator, Sharp HealthCare
    • Ahmed Salem, MD, Principal Investigator, Sharp HealthCare
  • Overall Contact(s)
    • Katie Miller, (858) 939-7162, Kathryn.Miller@sharp.com

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