Core Warming in COVID-19 Patients Undergoing Mechanical Ventilation

Sharp HealthCare

Status: Completed

Conditions: Covid19

Treatments: Device: Core Warming; Other: Standard of Care

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04494867

COVID-19 Core Warming

Details and patient eligibility

About

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 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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Core warming

Experimental group

Description:

Patients receive the Attune Medical Esophageal Heat Transfer Device (EnsoETM) and undergo core warming

Treatment:

Device: Core Warming

Standard of Care

Active Comparator group

Description:

Patients receive standard temperature management and treatment

Treatment:

Other: Standard of Care