Initiation of Cooling by EMS to Promote Adoption of In-hospital Hypothermia in Cardiac Arrest Survivors
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Purpose
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 | Intervention |
|---|---|
|
Out of Hospital Cardiac Arrest |
Behavioral: Pre-hospital cooling |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (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 |
- Success of in-hospital cooling [ Time Frame: within 6 hours of emergency department arrival ] [ Designated as safety issue: No ]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.
- Mortality at hospital discharge [ Time Frame: Hospital discharge ] [ Designated as safety issue: No ]Proportion of deaths at hospital discharge
- Mortality during transport [ Time Frame: During transport to hospital ] [ Designated as safety issue: Yes ]Proportion of patients that die after randomization and during transport to hospital.
- Mortality during 6 hours [ Time Frame: Within 6 hours of emergency department arrival ] [ Designated as safety issue: Yes ]Proportion of patients that die within 6 hours of emergency department arrival
- Cooling ever in hospital [ Time Frame: within 24 hours of emergency department arrival ] [ Designated as safety issue: No ]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 [ Time Frame: hospital discharge ] [ Designated as safety issue: No ]The median modified Rankin score at hospital discharge
- Good neurological outcome [ Time Frame: hospital discharge ] [ Designated as safety issue: No ]The proportion of patients with Modified Rankin Scale = 0, 1, or 2 at hospital discharge.
- Time of transport to hospital [ Time Frame: During transport to hospital ] [ Designated as safety issue: Yes ]Mean time (minutes) from arrival of paramedics on the scene to arrival and transport of patient to emergency department.
| Estimated Enrollment: | 900 |
| Study Start Date: | July 2012 |
| Estimated Study Completion Date: | December 2016 |
| Estimated Primary Completion Date: | December 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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| Contact: Damon Scales, MD PhD | 416-480-6100 ext 83734 | damon.scales@sunnybrook.ca |
| Contact: Toula Gonedalles, BSc. | 416-864-6060 ext 7872 | gonedallese@smh.ca |
| Canada, Ontario | |
| Peel Emergency Medical Services | Recruiting |
| Mississauga, Ontario, Canada | |
| Halton Emergency Medical Services | Recruiting |
| Oakville, Ontario, Canada | |
| Toronto Emergency Medical Services | Recruiting |
| Toronto, Ontario, Canada | |
| Principal Investigator: | Damon Scales, MD | Sunnybrook Hospital |
| Study Chair: | Laurie Morrison, M.D. | St. Michael's Hospital, 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 |
More Information
No publications provided
| Responsible Party: | Sunnybrook Health Sciences Centre |
| ClinicalTrials.gov Identifier: | NCT01528475 History of Changes |
| Other Study ID Numbers: | ICE PACS |
| Study First Received: | October 31, 2011 |
| Last Updated: | February 22, 2013 |
| Health Authority: | Canada: Health Canada |
Keywords provided by Sunnybrook Health Sciences Centre:
|
Therapeutic Hypothermia Cardiac arrest |
Additional relevant MeSH terms:
|
Heart Arrest Hypothermia Out-of-Hospital Cardiac Arrest Heart Diseases |
Cardiovascular Diseases Body Temperature Changes Signs and Symptoms |
ClinicalTrials.gov processed this record on May 19, 2013