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

NCT01528475 | Completed DMC

• 1 other identifier: ICE PACS
• Study Type: interventional
• Target: 585
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Out of Hospital Cardiac Arrest

Keywords

Therapeutic Hypothermia; Cardiac arrest

Outcome Measures

Primary Outcomes (1)

• Success of in-hospital cooling

  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.

  within 6 hours of emergency department arrival

Secondary Outcomes (7)

• Mortality at hospital discharge

  Hospital discharge

• Mortality during transport

  During transport to hospital

• Mortality during 6 hours

  Within 6 hours of emergency department arrival

• Cooling ever in hospital

  within 24 hours of emergency department arrival

• Median Modified Rankin score at hospital discharge

  hospital discharge

Study Arms (2)

Pre-hospital cooling

ACTIVE COMPARATOR

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.

Behavioral: Pre-hospital cooling

Usual pre-hospital care

NO INTERVENTION

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.

Interventions

Pre-hospital cooling 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.

Pre-hospital cooling

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead

Study Sites (3)

Peel Emergency Medical Services

Mississauga, Ontario, Canada

Location

Halton Emergency Medical Services

Oakville, Ontario, Canada

Location

Toronto Emergency Medical Services

Toronto, Ontario, Canada

Location

MeSH Terms

Conditions

Out-of-Hospital Cardiac Arrest; Heart Arrest

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Damon Scales, MD

  Sunnybrook Hospital

  PRINCIPAL INVESTIGATOR

• Laurie Morrison, M.D.

  Unity Health Toronto

  STUDY CHAIR

• Steven Brooks, M.D.

  Clinical Scientist

  STUDY CHAIR

• Rick Verbeek, MD

  Sunnybrook Centre for Prehospital Medicine

  STUDY CHAIR

• Sheldon Cheskes, MD

  Sunnybrook Centre for Prehospital Medicine

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2011
• First Posted: February 8, 2012
• Study Start: July 1, 2012
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: December 19, 2016

Record last verified: 2016-12

Locations

CA (3)