Initiation of Cooling by Emergency Medical Services to Promote the Adoption of In-hospital Therapeutic Hypothermia in Cardiac Arrest Survivors: the ICE-PACS Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Out of Hospital Cardiac Arrest
- Sponsor
- Sunnybrook Health Sciences Centre
- Enrollment
- 585
- Locations
- 3
- Primary Endpoint
- Success of in-hospital cooling
- Status
- Completed
- Last Updated
- 9 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Success of in-hospital cooling
Time Frame: 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 Outcomes
- 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)
- Good neurological outcome(hospital discharge)
- Time of transport to hospital(During transport to hospital)