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Core Warming in COVID-19 Patients Undergoing Mechanical Ventilation

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04494867
Enrollment
20
Registered
2020-07-31
Start date
2020-08-19
Completion date
2022-02-28
Last updated
2023-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Covid19

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.

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

DEVICECore 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.

OTHERStandard of Care

Standard temperature management and treatment

Sponsors

Advanced Cooling Therapy, Inc., d/b/a Attune Medical
CollaboratorINDUSTRY
Sharp HealthCare
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
PaO2/FiO2 Ratio0, 24, 48, and 72 hours after initiation of core warmingDetermine 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

MeasureTime frameDescription
Cycle Threshold at 72-hours72 hours after initiation of core warmingDetermine the change cycle threshold after implementation of core warming of ventilated patients, and compare this change to patients undergoing standard care.
Ventilator-Free DaysInitiation of Core Warming Until Patient Weaned Off Mechanical VentilationMeasure the impact of core warming on duration of mechanical ventilation.
30-Day Mortality30 days after initiation of core warmingDetermine impact of core warming on patient mortality.

Countries

United States

Participant flow

Participants by arm

ArmCount
Core Warming
Patients who received the Attune Medical Esophageal Heat Transfer Device (EnsoETM) and undergo core warming 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.
9
Standard of Care
Patients who received standard temperature management and treatment Standard of Care: Standard temperature management and treatment
10
Total19

Baseline characteristics

CharacteristicCore WarmingStandard of CareTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
4 Participants4 Participants8 Participants
Age, Categorical
Between 18 and 65 years
5 Participants6 Participants11 Participants
Age, Continuous61.7 years
STANDARD_DEVIATION 15.1
59.4 years
STANDARD_DEVIATION 10.3
60.5 years
STANDARD_DEVIATION 12.5
Allergies0 Participants1 Participants1 Participants
Baseline Cycle Threshold31.7 Cycles
STANDARD_DEVIATION 1.6
27.1 Cycles
STANDARD_DEVIATION 1.45
29.1 Cycles
STANDARD_DEVIATION 4.8
Body Mass Index35.8 kg/m^2
STANDARD_DEVIATION 7.8
33.4 kg/m^2
STANDARD_DEVIATION 3.4
34.5 kg/m^2
STANDARD_DEVIATION 5.9
Ethanol Usage1 Participants3 Participants4 Participants
Height1.623 meters
STANDARD_DEVIATION 0.104
1.687 meters
STANDARD_DEVIATION 0.098
1.66 meters
STANDARD_DEVIATION 0.1
Other Pre-Existing Condition3 Participants3 Participants6 Participants
Pre-Existing Cardiovascular Condition6 Participants8 Participants14 Participants
Pre-Existing Dermatologic Condition0 Participants0 Participants0 Participants
Pre-Existing Endocrine Condition8 Participants8 Participants16 Participants
Pre-Existing Gastrointestinal Condition1 Participants5 Participants6 Participants
Pre-Existing Genitourinary Condition at Baseline3 Participants4 Participants7 Participants
Pre-Existing HEENT Condition1 Participants1 Participants2 Participants
Pre-Existing Hematologic Condition5 Participants6 Participants11 Participants
Pre-Existing Hepatic Condition2 Participants4 Participants6 Participants
Pre-Existing Immunologic Condition3 Participants5 Participants8 Participants
Pre-Existing Musculoskeletal Condition6 Participants8 Participants14 Participants
Pre-Existing Neoplastic Condition0 Participants1 Participants1 Participants
Pre-Existing Neurologic Condition2 Participants2 Participants4 Participants
Pre-Existing Psychiatric Condition2 Participants1 Participants3 Participants
Pre-Existing Respiratory Condition at Baseline6 Participants7 Participants13 Participants
Race and Ethnicity Not Collected——0 Participants
Region of Enrollment
United States
9 participants10 participants19 participants
Sex: Female, Male
Female
4 Participants3 Participants7 Participants
Sex: Female, Male
Male
5 Participants7 Participants12 Participants
Time to Enrollment9.4 days
STANDARD_DEVIATION 13.1
9.1 days
STANDARD_DEVIATION 11.8
9.3 days
STANDARD_DEVIATION 12.1
Tobacco Usage1 Participants1 Participants2 Participants
Weight94.8 kilograms
STANDARD_DEVIATION 23.5
95.2 kilograms
STANDARD_DEVIATION 14.2
95.1 kilograms
STANDARD_DEVIATION 18.6

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
2 / 94 / 10
other
Total, other adverse events
9 / 99 / 10
serious
Total, serious adverse events
1 / 92 / 10

Outcome results

Primary

PaO2/FiO2 Ratio

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.

Time frame: 0, 24, 48, and 72 hours after initiation of core warming

ArmMeasureGroupValue (MEAN)Dispersion
Core WarmingPaO2/FiO2 Ratio0-hour timepoint119.1435 RatioStandard Error 11.57574
Core WarmingPaO2/FiO2 Ratio24-hour timepoint130.0138 RatioStandard Error 17.01536
Core WarmingPaO2/FiO2 Ratio48-hour timepoint158.2389 RatioStandard Error 19.43118
Core WarmingPaO2/FiO2 Ratio72-hour timepoint134.3884 RatioStandard Error 13.41839
Standard of CarePaO2/FiO2 Ratio72-hour timepoint196.9593 RatioStandard Error 32.0182
Standard of CarePaO2/FiO2 Ratio0-hour timepoint164.789 RatioStandard Error 19.42075
Standard of CarePaO2/FiO2 Ratio48-hour timepoint196.7167 RatioStandard Error 30.56792
Standard of CarePaO2/FiO2 Ratio24-hour timepoint154.9758 RatioStandard Error 21.10532
Secondary

30-Day Mortality

Determine impact of core warming on patient mortality.

Time frame: 30 days after initiation of core warming

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Core Warming30-Day Mortality2 Participants
Standard of Care30-Day Mortality4 Participants
Secondary

Cycle Threshold at 72-hours

Determine the change cycle threshold after implementation of core warming of ventilated patients, and compare this change to patients undergoing standard care.

Time frame: 72 hours after initiation of core warming

ArmMeasureValue (MEAN)Dispersion
Core WarmingCycle Threshold at 72-hours31.4 CyclesStandard Deviation 3.2
Standard of CareCycle Threshold at 72-hours30.8 CyclesStandard Deviation 6.4
Secondary

Ventilator-Free Days

Measure the impact of core warming on duration of mechanical ventilation.

Time frame: Initiation of Core Warming Until Patient Weaned Off Mechanical Ventilation

ArmMeasureValue (MEAN)Dispersion
Core WarmingVentilator-Free Days6.8 daysStandard Deviation 10.2
Standard of CareVentilator-Free Days11.9 daysStandard Deviation 12.6

Source: ClinicalTrials.gov · Data processed: Feb 8, 2026