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Core Warming in COVID-19 Patients Undergoing Mechanical Ventilation

NCT04494867 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2023-03-09

Study results available
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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.

Conditions

  • Covid19

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

Sponsors & Collaborators

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

    collaborator INDUSTRY

  • Sharp HealthCare

    lead OTHER

Principal Investigators

  • David Willms, MD · Sharp HealthCare

  • Ahmed Salem, MD · Sharp HealthCare

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-19
Primary Completion
2022-02-28
Completion
2022-02-28
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04494867 on ClinicalTrials.gov