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

Sunnybrook Health Sciences Centre

Status: Completed

Conditions: Out of Hospital Cardiac Arrest

Treatments: Behavioral: Pre-hospital cooling

Study type: Interventional

Funder types: Other

Identifiers

NCT01528475

ICE PACS

Details and patient eligibility

About

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.

Full 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.

Enrollment: 585 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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585 participants in 2 patient groups

Pre-hospital cooling

Active Comparator group

Description:

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.

Treatment:

Behavioral: Pre-hospital cooling

Usual pre-hospital care

No Intervention group

Description:

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.