Cardiac Arrest With Successful ResuscitationNCT03889340
Study of Brain Cools Device in Patients Resuscitated From Cardiac Arrest
An observational study of Cardiac Arrest With Successful Resuscitation, run by Adam Frisch at 1 site in United States.
Trial summary
This submission is a pilot in which the new IQool Warming System device will be used to maintain the temperature of adult patients in cardiac arrest within a range of within a range of 32°C to 38.5°C (89.6°F to 101.3°F). The IQool Warming System has received a 510 K Clearance by the FDA. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Arrest With Successful Resuscitation
- What is being tested?
- IQool
- Type of treatment
- Medical device
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2019to 1 Dec 2021
- Phase
- Observational
- 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
- Adult, Older adult
Study population: Study participants will be cardiac arrest patients that have been successfully resuscitated.
Who may be able to join
- In- or out-of-hospital cardiac arrest of all initial rhythms
- Adult patients (18 years of age and older)
- Unconscious on admission to hospital, defined as not following commands
- Indication for targeted temperature management
Who cannot join
- Pregnancy
- Prisoner
- Active do not resuscitate order
- Any patient not expected to survive 72 hours
- Skin infection
- Skin wound affecting site of temperature exchange pads
Trial locations and contacts
1 site in 1 country.
United States1 site
UPMC Presbyterian Hospital
Pittsburgh, Pennsylvania, 15216
About this study
This submission is a pilot in which the new IQool Warming System device will be used to maintain the temperature of adult patients in cardiac arrest within a range of within a range of 32°C to 38.5°C (89.6°F to 101.3°F). The IQool Warming System has received a 510 K Clearance by the FDA.
Read the detailed description
Subjects will receive temperature management using the IQool. This is an FDA approved device. Managing temperature is part of standard care for this population and surface cooling is commonly employed.
The following phases will be conducted as standard of care, and will be reviewed for this study:
Induction phase: When a subject is included in the study, the IQool will be connected to the patient and activated. The induction period will continue until the patient has reached the upper limit of the target temperature range (defined as 0.5°C above the target temperature).
Maintenance phase: Set target temperature will be maintained for 24 hours. The maintenance phase begins when the subject temperature is within 0.5°C of goal temperature. The maintenance phase is completed 24 hours after first reaching below the upper limit of the target temperature range.
Rewarming phase: After 24 hours of maintenance, gradual rewarming at 0.25 °C/h will commence. When the subject reaches 37°C the TTM period is completed and the IQool will continue to provide fever control.
Post TTM fever control: The subject will be kept at a body temperature of 37°C until 72 hours after the cardiac arrest or earlier if the subject regains consciousness.
- Being tested
- IQool
- Keywords
- resuscitation, cardiac arrest, coma
- Medical subject headings
- Heart Arrest, Coma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IQoolDevice
Subjects will undergo hypothermia therapy with the IQool system
| Study group | Role | What they receive |
|---|---|---|
| Phase 1 cohort | Subjects resuscitated from cardiac arrest will undergo cooling per standard of care with the IQool device. Receives: Device: IQool |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of hypothermia induction
Induction of hypothermia will occur at a rate of at least 1C/hr
Measured: Up to 12 hours
Maintenance of hypothermia
The IQool system will maintain temperature within 0.5C of goal temperature for 75% of the maintenance phase
Measured: 24 hours
Rewarming rate
When rewarming, the IQool system will rewarm within 0.5C of the goal rate of rewarming
Measured: Up to16 hours
Secondary outcomes (1)
Number of physicians that recommend the IQool system for temperature management
Clinicians will be asked if they agree that the IQool system provides effective temperature management >90% of the time
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2019
- Study start1 May 2019
- Primary completion31 May 2021
- Study completion1 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac Arrest With Successful ResuscitationStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Adam Frisch
- Sponsor type
- University, hospital or other
- Collaborators
- BrainCool
- Responsible party
- Sponsor-investigator, Adam Frisch, University of Pittsburgh
- Investigators
- Jon Rittenberger, MD, Principal investigator, Associate Professor of Emergency Medicine, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03889340
- Sponsor's protocol ID
- PRO18060375
- Status last verified
- Dec 2021
- First submitted
- 19 Mar 2019
- Last updated
- 17 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Brain Cools Device in Patients Resuscitated From Cardiac Arrest
- ClinicalTrials.gov ID
- NCT03889340
- Acronym / sponsor ID
- PRO18060375
- Keywords
- resuscitation, cardiac arrest, coma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Adam FrischUniversity, hospital or other
- Collaborators
- BrainCool
- Study start
- 1 May 2019 (actual)
- Primary completion
- 31 May 2021 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 26 Mar 2019 (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 submission is a pilot in which the new IQool Warming System device will be used to maintain the temperature of adult patients in cardiac arrest within a range of within a range of 32°C to 38.5°C (89.6°F to 101.3°F). The IQool Warming System has received a 510 K Clearance by the FDA.
Detailed description
Subjects will receive temperature management using the IQool. This is an FDA approved device. Managing temperature is part of standard care for this population and surface cooling is commonly employed.
The following phases will be conducted as standard of care, and will be reviewed for this study:
Induction phase: When a subject is included in the study, the IQool will be connected to the patient and activated. The induction period will continue until the patient has reached the upper limit of the target temperature range (defined as 0.5°C above the target temperature).
Maintenance phase: Set target temperature will be maintained for 24 hours. The maintenance phase begins when the subject temperature is within 0.5°C of goal temperature. The maintenance phase is completed 24 hours after first reaching below the upper limit of the target temperature range.
Rewarming phase: After 24 hours of maintenance, gradual rewarming at 0.25 °C/h will commence. When the subject reaches 37°C the TTM period is completed and the IQool will continue to provide fever control.
Post TTM fever control: The subject will be kept at a body temperature of 37°C until 72 hours after the cardiac arrest or earlier if the subject regains consciousness.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Phase 1 cohort | – | Device: IQoolSubjects resuscitated from cardiac arrest will undergo cooling per standard of care with the IQool device. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Study participants will be cardiac arrest patients that have been successfully resuscitated.
Key inclusion criteria (4 listed)
- In- or out-of-hospital cardiac arrest of all initial rhythms
- Adult patients (18 years of age and older)
- Unconscious on admission to hospital, defined as not following commands
- Indication for targeted temperature management
Key exclusion criteria (6 listed)
- Pregnancy
- Prisoner
- Active do not resuscitate order
- Any patient not expected to survive 72 hours
- Skin infection
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 |
|---|---|---|
| IQoolSubjects will undergo hypothermia therapy with the IQool system | Device | Phase 1 cohort |
Primary outcome
Rate of hypothermia induction
Time frame: Up to 12 hours
Induction of hypothermia will occur at a rate of at least 1C/hr
Maintenance of hypothermia
Time frame: 24 hours
The IQool system will maintain temperature within 0.5C of goal temperature for 75% of the maintenance phase
Rewarming rate
Time frame: Up to16 hours
When rewarming, the IQool system will rewarm within 0.5C of the goal rate of rewarming
1 secondary outcome
Number of physicians that recommend the IQool system for temperature management
Time frame: 72 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2021.
Related trials for Cardiac Arrest With Successful Resuscitation
Active, not recruiting
Sedation, Temperature and Pressure After Cardiac Arrest and Resuscitation
Cardiac Arrest With Successful Resuscitation, Hypoxia, Brain
Enrolling by invitationObservational study
A Study on the Impact of a New Canton-Wide First Responder System in Zug, Switzerland, on Survival After Adult Cardiac Arrest-Examining Early Life-Saving Organized Help, Fast Defibrillation, and Improved Outcomes for Out of Hospital Cardiac Arrest
Cardiac Arrest (CA), Cardiac Arrest With Successful Resuscitation
RecruitingPhase 2
CardioPulmonary Resuscitation With Argon (CPAr) Trial
Cardiac Arrest, Out-Of-Hospital, Cardiac Arrest With Successful Resuscitation
RecruitingObservational study
Optimization of Transport and Use of a Mobile ECMO Team in Patients With Sudden Cardiac Arrest in the Moravian-Silesian Region
Cardiac Arrest With Successful Resuscitation, Cardiac Arrest, Cause Unspecified
Recruiting
Stepcare Extended Follow-up Substudy
Cardiac Arrest With Successful Resuscitation, Hypoxia, Brain
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.
Jon Rittenberger, MD principal investigator
Associate Professor of Emergency Medicine, University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Arrest With Successful Resuscitation, run by Adam Frisch 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 17 Dec 2021. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Rate of hypothermia induction (time frame: Up to 12 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Dec 2021.