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Initiation of Cooling by EMS to Promote Adoption of In-hospital Hypothermia in Cardiac Arrest Survivors

NCT ID: NCT01528475

Last Updated: 2016-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

585 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2016-06-30

Brief Summary

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This is a large pragmatic, randomized controlled trial comparing pre-hospital initiation of therapeutic hypothermia by Emergency Medical Services (EMS) providers to conventional post-resuscitation care. The goal of this trial is to increase the proportion of cardiac arrest patients that are appropriately treated in-hospital with therapeutic hypothermia to reach the target body temperature within 6 hours of hospital arrival. The investigators believe that EMS-initiation of cooling will be a powerful reminder to in-hospital clinicians to continue therapeutic hypothermia, and will lead to care improvements across a health system.

Detailed Description

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This is a large pragmatic, randomized controlled trial comparing pre-hospital initiation of therapeutic hypothermia by Emergency Medical Services (EMS) providers to conventional post-resuscitation care. The goal of this trial is to increase the proportion of cardiac arrest patients that are appropriately treated in-hospital with therapeutic hypothermia to reach the target body temperature within 6 hours of hospital arrival. The investigators believe that EMS-initiation of cooling will be a powerful reminder to in-hospital clinicians to continue therapeutic hypothermia, and will lead to care improvements across a health system. This study builds on our previous work using large hospital networks hospitals to improve the delivery of evidence-based practice.

The primary research question is as follows: Does pre-hospital initiation of therapeutic hypothermia by EMS providers increase the proportion of comatose out of hospital cardiac arrest patients with return of spontaneous circulation (ROSC) that are successfully cooled to a target temperature of 32 to 34 degrees Celsius within 6 hours of emergency department arrival, compared to usual post-resuscitation care provided in the field? The primary outcome is the proportion of included patients that are successfully cooled to reach target temperature of 32 to 34 degrees Celsius within 6 hours of emergency department arrival.

Conditions

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Out of Hospital Cardiac Arrest

Keywords

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Therapeutic Hypothermia Cardiac arrest

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Pre-hospital cooling

Patients in this arm will receive pre-hospital cooling by paramedics. This treatment includes placement of surface ice-pacs, initiation of an intravenous infusion of cold saline, and wrist and ankle bands with text to remind in-hospital clinicians to continue therapeutic hypothermia.

Group Type ACTIVE_COMPARATOR

Pre-hospital cooling

Intervention Type BEHAVIORAL

Patients in this arm will receive pre-hospital cooling by paramedics. This treatment includes placement of surface ice-pacs on the neck, groin, and axillae; midazolam to prevent shivering; initiation of an intravenous infusion of cold saline; and wrist and ankle bands with text to remind in-hospital clinicians to continue therapeutic hypothermia.

Usual pre-hospital care

Patients in this arm will receive usual post-resuscitation care by paramedics. Usual post-resuscitation care does not include initiation of cooling in the pre-hospital setting.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Pre-hospital cooling

Patients in this arm will receive pre-hospital cooling by paramedics. This treatment includes placement of surface ice-pacs on the neck, groin, and axillae; midazolam to prevent shivering; initiation of an intravenous infusion of cold saline; and wrist and ankle bands with text to remind in-hospital clinicians to continue therapeutic hypothermia.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Pulseless OHCA in the study communities (any rhythm, initial rhythm will be recorded)
* Age equal to or greater than 18 years
* Defibrillation and/or chest compressions by EMS providers (including fire fighters)
* Return of spontaneous circulation (ROSC) sustained for greater than or equal to 5 minutes
* Patient is unresponsive to verbal stimulus using AVPU (Alert, Voice, Pain, Unresponsive) scale
* Patient is endotracheally intubated
* SBP equal to or greater than 100 mm Hg (even if needing dopamine)

Exclusion Criteria

* Trauma (including burns) associated with cardiac arrest
* Sepsis or serious infection suspected as cause of cardiac arrest
* Clinical evidence of active severe bleeding
* Suspected hypothermic cardiac arrest
* Known coagulopathy (medical history or medications; ASA and clopidogrel are permitted)
* Any verbal or written do-not-resuscitate (DNR)
* Obviously pregnant
* Known Prisoner
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sunnybrook Health Sciences Centre

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Damon Scales, MD

Role: PRINCIPAL_INVESTIGATOR

Sunnybrook Hospital

Laurie Morrison, M.D.

Role: STUDY_CHAIR

Unity Health Toronto

Steven Brooks, M.D.

Role: STUDY_CHAIR

Clinical Scientist

Rick Verbeek, MD

Role: STUDY_CHAIR

Sunnybrook Centre for Prehospital Medicine

Sheldon Cheskes, MD

Role: STUDY_CHAIR

Sunnybrook Centre for Prehospital Medicine

Locations

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Peel Emergency Medical Services

Mississauga, Ontario, Canada

Site Status

Halton Emergency Medical Services

Oakville, Ontario, Canada

Site Status

Toronto Emergency Medical Services

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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ICE PACS

Identifier Type: -

Identifier Source: org_study_id