COVID 19NCT04426344
Core Warming of COVID-19 Patients
A study testing ensoETM device in people with COVID 19, run by Washington University School of Medicine at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID 19
- What is being tested?
- ensoETM device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2020to Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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.
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- Patients with history of esophageal disease
- Patients with a baseline epinephrine dose greater than 0.6 mcg/kg/min
- Patients with atrial fibrillation, atrial flutter, or other multifocal atrial tachycardia with a heart rate greater than 110 beats per minute.
- Patients on 0.2 mcg/kg/min or more of norepinephrine
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Core Warming of COVID-19 Patients Undergoing Mechanical Ventilation: a Randomized, Single Center Pilot Study
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.
Read the detailed description
Participants will be randomized in a 1:1 fashion to core warming with the study device (ensoETM) or to standard of care (standard temperature management and treatment). The device will be used as indicated (for warming). Patient temperature measurement will be collected for both the core warming and standard of care arms during the study period (72 hours).
Core warming will be performed using standard technique per instructions for use for the esophageal heat transfer device. The esophageal heat transfer device will be set to 42°C temperature after initial placement, and maintained at 42°C for the duration of treatment. It is expected that patient temperature will increase from baseline by 1°C to 2°C, but due to ongoing heat loss from the patient, the expected maximum patient temperature is below 39°C. The time course of illness of COVID-19 is such that most patients no longer have fever by the time of mechanical ventilation. If patient temperature increases above this range and reaches 39.8°C, the device will be set to an operating temperature of 40°C, thereby preventing any further increase in patient temperature (ambient heat loss precludes patient from reaching device operating temperature).
Control group patients will be managed as per standard of care currently utilized in the ICU, which will include the use of other methods of temperature management as warranted. This would include warming with a forced air blanket only in hypothermic patients (core temperature < 36°C) or antipyretic therapy for febrile patients, as requested by the treating physician. Episodes of hypothermia are infrequent and transient in this population, and the current standard of care generally utilizes a permissive approach to fever (allowing patients to remain mildly febrile) which will continue in the control group without modification (no intentional elevation of temperature will be provided in the control group).
Follow up data will be collected at 1 month following enrollment.
- Conditions
- COVID 19
- Being tested
- ensoETM device
- Keywords
- COVID 19, Warming, Mechanical ventilation
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ensoETM deviceDevice
Core warming will be performed using standard technique per instructions for use for the esophageal heat transfer device. The esophageal heat transfer device will be set to 42°C temperature after initial placement, and maintained at 42°C for the duration of treatment. It is expected that patient temperature will increase from baseline by 1°C to 2°C, but due to ongoing heat loss from the patient, the expected maximum patient temperature is below 39°C. The time course of illness of COVID-19 is such that most patients no longer have fever by the time of mechanical ventilation.[41] If patient temperature increases above this range and reaches 39.8°C, the device will be set to an operating temperature of 40°C, thereby preventing any further increase in patient temperature (ambient heat loss precludes patient from reaching device operating temperature).
| Study group | Role | What they receive |
|---|---|---|
| Group A - core warming | Experimental | Patients randomized to Group A will have core warming with the ensoETM device initiated in the ICU or other clinical environment in which they are being treated. The device will be used as indicated (for warming). Patient temperature measurement will be collected for both the core warming and standard of care arms during the study period (72 hours). Receives: Device: ensoETM device |
| Group B - Control Group | No intervention | Group B is serving as the control group who will not have the ensoETM device used.Control group patients will be managed as per standard of care currently utilized in the ICU, which will include the use of other methods of temperature management as warranted. This would include warming with a forced air blanket only in hypothermic patients (core temperature < 36°C) or antipyretic therapy for febrile patients, as requested by the treating physician. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Viral load measured in tracheal aspirate 72 hours after initiation of core warming
This endpoint will be compared between patients receiving core warming and those randomized to undergo standard care (standard temperature management, with or without antipyretics as needed) in order to determine an initial estimate of effect size and provide data from which to design adequately powered investigation and apply appropriate statistical testing.
Measured: 72 hours
Secondary outcomes (2)
PaO2/FiO2 ratio 72 hours after initiation of core warming
Measured: 72 hours
Duration of mechanical ventilation
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study startOct 2020 (estimated)
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Why it stopped: Internal decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID 19Studies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- 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
- Model description
- Randomized, single center pilot study
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anne Drewry, MD, Principal investigator, Washington Univeristy School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04426344
- Sponsor's protocol ID
- 202005150
- Status last verified
- Oct 2020
- First submitted
- 3 Jun 2020
- Last updated
- 19 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Bonfanti N, Gundert E, Drewry AM, Goff K, Bedimo R, Kulstad E. Core warming of coronavirus disease 2019 (COVID-19) patients undergoing mechanical ventilation-A protocol for a randomized controlled pilot study. PLoS One. 2020 Dec 1;15(12):e0243190. doi: 10.1371/journal.pone.0243190. eCollection 2020.
PubMed 33259540
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2020. 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
- NCT04426344
- Acronym / sponsor ID
- 202005150
- Conditions
- COVID 19
- Keywords
- COVID 19, Warming, Mechanical ventilation
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Internal decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- Oct 2020 (estimated)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 11 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Participants will be randomized in a 1:1 fashion to core warming with the study device (ensoETM) or to standard of care (standard temperature management and treatment). The device will be used as indicated (for warming). Patient temperature measurement will be collected for both the core warming and standard of care arms during the study period (72 hours).
Core warming will be performed using standard technique per instructions for use for the esophageal heat transfer device. The esophageal heat transfer device will be set to 42°C temperature after initial placement, and maintained at 42°C for the duration of treatment. It is expected that patient temperature will increase from baseline by 1°C to 2°C, but due to ongoing heat loss from the patient, the expected maximum patient temperature is below 39°C. The time course of illness of COVID-19 is such that most patients no longer have fever by the time of mechanical ventilation. If patient temperature increases above this range and reaches 39.8°C, the device will be set to an operating temperature of 40°C, thereby preventing any further increase in patient temperature (ambient heat loss precludes patient from reaching device operating temperature).
Control group patients will be managed as per standard of care currently utilized in the ICU, which will include the use of other methods of temperature management as warranted. This would include warming with a forced air blanket only in hypothermic patients (core temperature < 36°C) or antipyretic therapy for febrile patients, as requested by the treating physician. Episodes of hypothermia are infrequent and transient in this population, and the current standard of care generally utilizes a permissive approach to fever (allowing patients to remain mildly febrile) which will continue in the control group without modification (no intentional elevation of temperature will be provided in the control group).
Follow up data will be collected at 1 month following enrollment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized, single center pilot study
| Arm | Type | Receives |
|---|---|---|
| Group A - core warming | Experimental | Device: ensoETM devicePatients randomized to Group A will have core warming with the ensoETM device initiated in the ICU or other clinical environment in which they are being treated. The device will be used as indicated (for warming). Patient temperature measurement will be collected for both the core warming and standard of care arms during the study period (72 hours). |
| Group B - Control Group | No intervention | –Group B is serving as the control group who will not have the ensoETM device used.Control group patients will be managed as per standard of care currently utilized in the ICU, which will include the use of other methods of temperature management as warranted. This would include warming with a forced air blanket only in hypothermic patients (core temperature < 36°C) or antipyretic therapy for febrile patients, as requested by the treating physician. |
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 (10 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 |
|---|---|---|
| ensoETM deviceCore warming will be performed using standard technique per instructions for use for the esophageal heat transfer device. The esophageal heat transfer device will be set to 42°C temperature after initial placement, and maintained at 42°C for the duration of treatment. It is expected that patient temperature will increase from baseline by 1°C to 2°C, but due to ongoing heat loss from the patient, the expected maximum patient temperature is below 39°C. The time course of illness of COVID-19 is such that most patients no longer have fever by the time of mechanical ventilation.[41] If patient temperature increases above this range and reaches 39.8°C, the device will be set to an operating temperature of 40°C, thereby preventing any further increase in patient temperature (ambient heat loss precludes patient from reaching device operating temperature). | Device | Group A - core warming |
Primary outcome
Viral load measured in tracheal aspirate 72 hours after initiation of core warming
Time frame: 72 hours
This endpoint will be compared between patients receiving core warming and those randomized to undergo standard care (standard temperature management, with or without antipyretics as needed) in order to determine an initial estimate of effect size and provide data from which to design adequately powered investigation and apply appropriate statistical testing.
2 secondary outcomes
PaO2/FiO2 ratio 72 hours after initiation of core warming
Time frame: 72 hours
Duration of mechanical ventilation
Time frame: 30 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2020.
- Derived from this study: PubMed 33259540Bonfanti N, Gundert E, Drewry AM, Goff K, Bedimo R, Kulstad E. Core warming of coronavirus disease 2019 (COVID-19) patients undergoing mechanical ventilation-A protocol for a randomized controlled pilot study. PLoS One. 2020 Dec 1;15(12):e0243190. doi: 10.1371/journal.pone.0243190. eCollection 2020.
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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.
Anne Drewry, MD principal investigator
Washington Univeristy School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ensoETM device in people with COVID 19, run by Washington University School of Medicine 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 10 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: withdrawn, as of the sponsor's last update on 19 Oct 2020. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Viral load measured in tracheal aspirate 72 hours after initiation of core warming (time frame: 72 hours). 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 NCT04426344, which also lists 1 linked publication.
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 19 Oct 2020.