Core Warming in COVID-19 Patients Undergoing Mechanical Ventilation

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-19

Study Completion Date

2022-02-28

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Covid19

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Core warming

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

Group Type EXPERIMENTAL

Core Warming

Intervention Type DEVICE

Esophageal heat transfer device will be set to 42°C temperature after initial placement, and maintained at 42°C for the duration of treatment.

Standard of Care

Patients receive standard temperature management and treatment

Group Type ACTIVE_COMPARATOR

Standard of Care

Intervention Type OTHER

Standard temperature management and treatment

Interventions

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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.

Intervention Type DEVICE

Standard of Care

Standard temperature management and treatment

Intervention Type OTHER

Other Intervention Names

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EnsoETM

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No