Covid19NCT04494867
Core Warming in COVID-19 Patients Undergoing Mechanical Ventilation
A study testing Core Warming in people with Covid19, run by Sharp HealthCare at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19
- What is being tested?
- Core Warming
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Aug 2020to 28 Feb 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Sharp Memorial Hospital
San Diego, California, 92123
About this study
Official title: Core Warming of COVID-19 Patients Undergoing Mechanical Ventilation: a Randomized, Single Center Pilot Study
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.
Read the 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.
- Conditions
- Covid19
- Being tested
- Core Warming, Standard of Care
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Core WarmingDevice
Also called EnsoETM
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 CareOther
Standard temperature management and treatment
| Study group | Role | What they receive |
|---|---|---|
| Core warming | Experimental | Patients receive the Attune Medical Esophageal Heat Transfer Device (EnsoETM) and undergo core warming Receives: Device: Core Warming |
| Standard of Care | Active comparator | Patients receive standard temperature management and treatment Receives: Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 0, 24, 48, and 72 hours after initiation of core warming
Secondary outcomes (3)
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.
Measured: 72 hours after initiation of core warming
Ventilator-Free Days
Measure the impact of core warming on duration of mechanical ventilation.
Measured: Initiation of Core Warming Until Patient Weaned Off Mechanical Ventilation
30-Day Mortality
Determine impact of core warming on patient mortality.
Measured: 30 days after initiation of core warming
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2020
- Study start19 Aug 2020
- Primary completion28 Feb 2022
- Study completion28 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sharp HealthCare
- Sponsor type
- University, hospital or other
- Collaborators
- Advanced Cooling Therapy, Inc., d/b/a Attune Medical
- Responsible party
- Principal investigator, David Willms, MD, Sharp HealthCare
- Investigators
- David Willms, MD, Principal investigator, Sharp HealthCareAhmed Salem, MD, Principal investigator, Sharp HealthCare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04494867
- Sponsor's protocol ID
- COVID-19 Core Warming
- Status last verified
- Feb 2023
- First submitted
- 29 Jul 2020
- Last updated
- 9 Mar 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
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.
PubMed 31058720Drewry 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.
PubMed 29240644Drewry 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.
PubMed 28221185Drewry 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.
PubMed 25793436Drewry 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.
PubMed 24028682Drewry 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.
PubMed 32709253Bonfanti 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.
PubMed 37527424
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Core Warming of COVID-19 Patients Undergoing Mechanical Ventilation: a Randomized, Single Center Pilot Study
- ClinicalTrials.gov ID
- NCT04494867
- Acronym / sponsor ID
- COVID-19 Core Warming
- Conditions
- Covid19
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Sharp HealthCareUniversity, hospital or other
- Collaborators
- Advanced Cooling Therapy, Inc., d/b/a Attune Medical
- Study start
- 19 Aug 2020 (actual)
- Primary completion
- 28 Feb 2022 (actual)
- Study completion
- 28 Feb 2022 (actual)
- First posted
- 31 Jul 2020 (actual)
- Results
- Posted 9 Mar 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Core warming | Experimental | Device: Core WarmingPatients receive the Attune Medical Esophageal Heat Transfer Device (EnsoETM) and undergo core warming |
| Standard of Care | Active comparator | Other: Standard of CarePatients receive standard temperature management and treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Core WarmingAlso: EnsoETMEsophageal heat transfer device will be set to 42°C temperature after initial placement, and maintained at 42°C for the duration of treatment. | Device | Core warming |
| Standard of CareStandard temperature management and treatment | Other | Standard of Care |
Primary outcome
PaO2/FiO2 Ratio
Time frame: 0, 24, 48, and 72 hours after initiation of core warming
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.
3 secondary outcomes
Cycle Threshold at 72-hours
Time frame: 72 hours after initiation of core warming
Ventilator-Free Days
Time frame: Initiation of Core Warming Until Patient Weaned Off Mechanical Ventilation
30-Day Mortality
Time frame: 30 days after initiation of core warming
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 31058720Evans 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.
- Background: PubMed 29240644Drewry 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.
- Background: PubMed 28221185Drewry 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.
- Background: PubMed 25793436Drewry 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.
- Background: PubMed 24028682Drewry 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.
- Background: PubMed 32709253Drewry 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.
- Derived from this study: PubMed 37527424Bonfanti 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Willms, MD principal investigator
Sharp HealthCare
Ahmed Salem, MD principal investigator
Sharp HealthCare
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Core Warming in people with Covid19, run by Sharp HealthCare at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Mar 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PaO2/FiO2 Ratio (time frame: 0, 24, 48, and 72 hours after initiation of core warming). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04494867, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2023.