Core Warming in COVID-19 Patients Undergoing Mechanical Ventilation

Covid19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04494867
• Other study ID #: COVID-19 Core Warming
• Status: Completed
• Phase: N/A
• Start date: August 19, 2020
• Est. completion date: February 28, 2022

Study information

• Verified date: February 2023
• Source: Sharp HealthCare
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: February 28, 2022
• Est. primary completion date: February 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• Covid19

Intervention

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

Locations

Country	Name	City	State
United States	Sharp Memorial Hospital	San Diego	California

Sponsors (2)

Lead Sponsor	Collaborator
Sharp HealthCare	Advanced Cooling Therapy, Inc., d/b/a Attune Medical

Country where clinical trial is conducted

United States, 

References & Publications (6)

Drewry AM, Ablordeppey EA, Murray ET, Dalton CM, Fuller BM, Kollef MH, Hotchkiss RS. Monocyte Function and Clinical Outcomes in Febrile and Afebrile Patients With Severe Sepsis. Shock. 2018 Oct;50(4):381-387. doi: 10.1097/SHK.0000000000001083. — View Citation

Drewry AM, Ablordeppey EA, Murray ET, Stoll CRT, Izadi SR, Dalton CM, Hardi AC, Fowler SA, Fuller BM, Colditz GA. Antipyretic Therapy in Critically Ill Septic Patients: A Systematic Review and Meta-Analysis. Crit Care Med. 2017 May;45(5):806-813. doi: 10.1097/CCM.0000000000002285. — View Citation

Drewry AM, Fuller BM, Bailey TC, Hotchkiss RS. Body temperature patterns as a predictor of hospital-acquired sepsis in afebrile adult intensive care unit patients: a case-control study. Crit Care. 2013 Sep 12;17(5):R200. doi: 10.1186/cc12894. — View Citation

Drewry AM, Fuller BM, Skrupky LP, Hotchkiss RS. The presence of hypothermia within 24 hours of sepsis diagnosis predicts persistent lymphopenia. Crit Care Med. 2015 Jun;43(6):1165-9. doi: 10.1097/CCM.0000000000000940. — View Citation

Drewry AM, Hotchkiss R, Kulstad E. Response to "Body temperature correlates with mortality in COVID-19 patients". Crit Care. 2020 Jul 24;24(1):460. doi: 10.1186/s13054-020-03186-w. No abstract available. — View Citation

Evans EM, Doctor RJ, Gage BF, Hotchkiss RS, Fuller BM, Drewry AM. The Association of Fever and Antipyretic Medication With Outcomes in Mechanically Ventilated Patients: A Cohort Study. Shock. 2019 Aug;52(2):152-159. doi: 10.1097/SHK.0000000000001368. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	0, 24, 48, and 72 hours after initiation of core warming
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.	72 hours after initiation of core warming
Secondary	Ventilator-Free Days	Measure the impact of core warming on duration of mechanical ventilation.	Initiation of Core Warming Until Patient Weaned Off Mechanical Ventilation
Secondary	30-Day Mortality	Determine impact of core warming on patient mortality.	30 days after initiation of core warming