Core Warming in COVID-19 Patients Undergoing Mechanical Ventilation

NCT04494867 | Completed Results FDA Device

• 1 other identifier: COVID-19 Core Warming
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Cycle Threshold at 72-hours

  72 hours after initiation of core warming

• Ventilator-Free Days

  Initiation of Core Warming Until Patient Weaned Off Mechanical Ventilation

• 30-Day Mortality

  30 days after initiation of core warming

Study Arms (2)

Core warming

EXPERIMENTAL

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

Device: Core Warming

Standard of Care

ACTIVE COMPARATOR

Patients receive standard temperature management and treatment

Other: Standard of Care

Interventions

Core Warming 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.

Also known as: EnsoETM

Core warming

Standard of Care OTHER

Standard temperature management and treatment

Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sharp HealthCare: lead
• Advanced Cooling Therapy, Inc., d/b/a Attune Medical: collaborator

Study Sites (1)

Sharp Memorial Hospital

San Diego, California, 92123, United States

Location

Related Publications (7)

• 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.

  PMID: 31058720 BACKGROUND

• 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.

  PMID: 29240644 BACKGROUND

• 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.

  PMID: 28221185 BACKGROUND

• 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.

  PMID: 25793436 BACKGROUND

• 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.

  PMID: 24028682 BACKGROUND

• 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.

  PMID: 32709253 BACKGROUND

• Bonfanti NP, Mohr NM, Willms DC, Bedimo RJ, Gundert E, Goff KL, Kulstad EB, Drewry AM. Core Warming of Coronavirus Disease 2019 Patients Undergoing Mechanical Ventilation: A Pilot Study. Ther Hypothermia Temp Manag. 2023 Dec;13(4):225-229. doi: 10.1089/ther.2023.0030. Epub 2023 Aug 2.

  PMID: 37527424 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: Erik Kulstad, MD
• Organization: Attune Medical

ekulstad@gmail.com

+1-708-651-0736

Study Officials

• David Willms, MD

  Sharp HealthCare

  PRINCIPAL INVESTIGATOR

• Ahmed Salem, MD

  Sharp HealthCare

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Clinical Care Services

Study Record Dates

• First Submitted: July 29, 2020
• First Posted: July 31, 2020
• Study Start: August 19, 2020
• Primary Completion: February 28, 2022
• Study Completion: February 28, 2022
• Last Updated: March 9, 2023
• Results First Posted: March 9, 2023

Record last verified: 2023-02

Locations

US (1)