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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 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pre-hospital cooling | Active Comparator | 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. |
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| Usual pre-hospital care | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pre-hospital cooling | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Success of in-hospital cooling | 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. | within 6 hours of emergency department arrival |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality at hospital discharge | Proportion of deaths at hospital discharge | Hospital discharge |
| Mortality during transport | Proportion of patients that die after randomization and during transport to hospital. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Damon Scales, MD | Sunnybrook Hospital | Principal Investigator |
| Laurie Morrison, M.D. | Unity Health 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 | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peel Emergency Medical Services | Mississauga | Ontario | Canada | |||
| Halton Emergency Medical Services |
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| ID | Term |
|---|---|
| D058687 | Out-of-Hospital Cardiac Arrest |
| D006323 | Heart Arrest |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| During transport to hospital |
| Mortality during 6 hours | Proportion of patients that die within 6 hours of emergency department arrival | Within 6 hours of emergency department arrival |
| Cooling ever in hospital | Proportion of patients for whom in-hospital therapeutic hypothermia is initiated or continued within 24 hours of emergency department arrival | within 24 hours of emergency department arrival |
| Median Modified Rankin score at hospital discharge | The median modified Rankin score at hospital discharge | hospital discharge |
| Good neurological outcome | The proportion of patients with Modified Rankin Scale = 0, 1, or 2 at hospital discharge. | hospital discharge |
| Time of transport to hospital | Mean time (minutes) from arrival of paramedics on the scene to arrival and transport of patient to emergency department. | During transport to hospital |
| Oakville |
| Ontario |
| Canada |
| Toronto Emergency Medical Services | Toronto | Ontario | Canada |