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

Initiation of Cooling by Emergency Medical Services to Promote the Adoption of In-hospital Therapeutic Hypothermia in Cardiac Arrest Survivors: the ICE-PACS Trial

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.

Study Overview

• Status: Completed
• Conditions: Out of Hospital Cardiac Arrest
• Intervention / Treatment: Behavioral: Pre-hospital cooling

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 585
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Mississauga, Ontario, Canada
      • Peel Emergency Medical Services
    • Oakville, Ontario, Canada
      • Halton Emergency Medical Services
    • Toronto, Ontario, Canada
      • Toronto Emergency Medical Services

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Behavioral: 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.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality at hospital discharge	Proportion of deaths at hospital discharge	Hospital discharge
Mortality during transport	Proportion of patients that die after randomization and during transport to hospital.	During transport to hospital
Mortality during 6 hours	Proportion of patients that die within 6 hours of emergency department arrival	Within 6 hours of emergency department arrival
Cooling ever in hospital	Proportion of patients for whom in-hospital therapeutic hypothermia is initiated or continued within 24 hours of emergency department arrival	within 24 hours of emergency department arrival
Median Modified Rankin score at hospital discharge	The median modified Rankin score at hospital discharge	hospital discharge
Good neurological outcome	The proportion of patients with Modified Rankin Scale = 0, 1, or 2 at hospital discharge.	hospital discharge
Time of transport to hospital	Mean time (minutes) from arrival of paramedics on the scene to arrival and transport of patient to emergency department.	During transport to hospital

Collaborators and Investigators

• Sponsor: Sunnybrook Health Sciences Centre
• Investigators: Principal Investigator: Damon Scales, MD, Sunnybrook Hospital; Study Chair: 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 record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: October 31, 2011
• First Submitted That Met QC Criteria: February 3, 2012
• First Posted (Estimate): February 8, 2012

Study Record Updates

• Last Update Posted (Estimate): December 19, 2016
• Last Update Submitted That Met QC Criteria: December 16, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Keywords: Cardiac arrest; Therapeutic Hypothermia
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Body Temperature Changes; Heart Arrest; Hypothermia; Out-of-Hospital Cardiac Arrest
• Other Study ID Numbers: ICE PACS