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Core Warming in COVID-19 Patients Undergoing Mechanical Ventilation

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ClinicalTrials.gov Identifier: NCT04494867
Recruitment Status : Recruiting
First Posted : July 31, 2020
Last Update Posted : September 25, 2020
Sponsor:
Collaborator:
Advanced Cooling Therapy, Inc., d/b/a Attune Medical
Information provided by (Responsible Party):
David Willms, MD, Sharp HealthCare

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, and greater overall survival.

Condition or disease Intervention/treatment Phase
Covid19 Device: Core Warming Other: Standard of Care Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Core Warming of COVID-19 Patients Undergoing Mechanical Ventilation: a Randomized, Single Center Pilot Study
Actual Study Start Date : August 19, 2020
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Arm Intervention/treatment
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 Name: EnsoETM

Active Comparator: Standard of Care
Patients receive standard temperature management and treatment
Other: Standard of Care
Standard temperature management and treatment




Primary Outcome Measures :
  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 Outcome Measures :
  1. Viral Load Measurement [ Time Frame: 72 hours after initiation of core warming ]
    Determine the change in viral load (measured in tracheal aspirate or other appropriate sample as available) after implementation of core warming of ventilated patients, and compare this change to patients undergoing standard care.

  2. Duration of mechanical ventilation [ Time Frame: 72 hours after initiation of core warming ]
    Measure the impact of core warming on duration of mechanical ventilation.

  3. Mortality [ Time Frame: 30 days ]
    Determine impact of core warming on patient mortality.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04494867


Contacts
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Contact: Katie Miller (858) 939-7162 Kathryn.Miller@sharp.com

Locations
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United States, California
Sharp Memorial Hospital Recruiting
San Diego, California, United States, 92123
Contact: Katie Miller    858-939-7162      
Principal Investigator: David Willms, MD         
Sub-Investigator: Ahmed Salem, MD         
Sponsors and Collaborators
Sharp HealthCare
Advanced Cooling Therapy, Inc., d/b/a Attune Medical
Investigators
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Principal Investigator: David Willms, MD Sharp HealthCare
Principal Investigator: Ahmed Salem, MD Sharp HealthCare
Publications:
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Responsible Party: David Willms, MD, Director, Clinical Care Services, Sharp HealthCare
ClinicalTrials.gov Identifier: NCT04494867    
Other Study ID Numbers: COVID-19 Core Warming
First Posted: July 31, 2020    Key Record Dates
Last Update Posted: September 25, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes