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

Sponsor

Sunnybrook Health Sciences Centre (Other)

Overall Status

Completed

CT.gov ID

NCT01528475

Collaborator

(none)

585

Enrollment

Locations

Arms

Duration (Months)

195

Patients Per Site

4.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Out of Hospital Cardiac Arrest	Behavioral: Pre-hospital cooling	N/A

Detailed Description

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 Design

Study Type:

Interventional

Actual Enrollment :

585 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Health Services Research

Official Title:

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

Study Start Date :

Jul 1, 2012

Actual Primary Completion Date :

Jun 1, 2016

Actual Study Completion Date :

Jun 1, 2016

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Success of in-hospital cooling [within 6 hours of emergency department arrival]
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.

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country
1	Peel Emergency Medical Services	Mississauga	Ontario	Canada
2	Halton Emergency Medical Services	Oakville	Ontario	Canada
3	Toronto Emergency Medical Services	Toronto	Ontario	Canada