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

Not Applicable

Completed

• Conditions: Out of Hospital Cardiac Arrest
• Interventions: Behavioral: Pre-hospital cooling

• Registration Number: NCT01528475
• Lead Sponsor: Sunnybrook Health Sciences Centre

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.

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 Timeline

• Study First Submitted: 2011-10-31
• Study First Submitted QC: 2012-02-03
• Study First Posted: 2012-02-08
• Study Start: 2012-07
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-16
• Last Update Posted: 2016-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 585

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pre-hospital cooling	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (3)

Halton Emergency Medical Services; 🇨🇦 Oakville, Ontario, Canada

Peel Emergency Medical Services; 🇨🇦 Mississauga, Ontario, Canada

Toronto Emergency Medical Services; 🇨🇦 Toronto, Ontario, Canada