Study of Brain Cools Device in Patients Resuscitated From... | NCT03889340

Studies
Study of Brain Cools Device in Patients Resuscitated From Cardiac Arrest

NCT03889340

Sponsor

Adam Frisch

Status

Completed

Last Update Posted

Dec 17, 2021Actual

Enrollment

38Actual

Phase

Not provided

Conditions

Cardiac Arrest With Successful Resuscitation

Interventions

IQool

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1, 2019Actual

Primary Completion Date

May 31, 2021Actual

Completion Date

Dec 1, 2021Actual

First Submitted Date

Mar 19, 2019

First Submission Date that Met QC Criteria

Mar 21, 2019

First Posted Date

Mar 26, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 6, 2021

Last Update Posted Date

Dec 17, 2021Actual

Name	Class
BrainCool	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

38Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Phase 1 cohort		Subjects resuscitated from cardiac arrest will undergo cooling per standard of care with the IQool device.	Device: IQool

Interventions

Name	Type	Description	Arm Group Labels	Other Names
IQool	Device	Subjects will undergo hypothermia therapy with the IQool system	Phase 1 cohort

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Rate of hypothermia induction	Induction of hypothermia will occur at a rate of at least 1C/hr	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	24 hours
Rewarming rate	When rewarming, the IQool system will rewarm within 0.5C of the goal rate of rewarming	Up to16 hours

Secondary Outcomes

Measure	Description	Time Frame
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	72 hours

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Study participants will be cardiac arrest patients that have been successfully resuscitated.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jon Rittenberger, MD	Associate Professor of Emergency Medicine, University of Pittsburgh	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UPMC Presbyterian Hospital		Pittsburgh	Pennsylvania	15216	United States

Condition Browse Module

MeSH Terms

ID	Term
D006323	Heart Arrest
D003128	Coma

Ancestor Terms

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D014474	Unconsciousness
D003244	Consciousness Disorders

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Browse Branches

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