Out of Hospital Cardiac Arrest
Conditions
Keywords
Therapeutic Hypothermia, Cardiac arrest
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.
Interventions
BEHAVIORALPre-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.
Sponsors
Sunnybrook Health Sciences Centre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Mortality at hospital discharge | Hospital discharge | Proportion of deaths 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. |
| Median Modified Rankin score at hospital discharge | hospital discharge | The median modified Rankin score at hospital discharge |
Countries
Canada
Outcome results
None listed