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

Sunnybrook Health Sciences Centre585 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

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.

Time frame: within 6 hours of emergency department arrival

Secondary Outcomes

Mortality at hospital discharge

Proportion of deaths at hospital discharge

Time frame: Hospital discharge

Mortality during transport

Proportion of patients that die after randomization and during transport to hospital.

Time frame: During transport to hospital

Mortality during 6 hours

Proportion of patients that die within 6 hours of emergency department arrival

Time frame: 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

Time frame: within 24 hours of emergency department arrival

Median Modified Rankin score at hospital discharge

The median modified Rankin score at hospital discharge

Time frame: hospital discharge

Good neurological outcome

The proportion of patients with Modified Rankin Scale = 0, 1, or 2 at hospital discharge.

Time frame: 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.