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

Study Overview
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Brief Summary
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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.

Detailed Description
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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 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.

Official Title
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Initiation of Cooling by Emergency Medical Services to Promote the Adoption of In-hospital Therapeutic Hypothermia in Cardiac Arrest Survivors: the ICE-PACS Trial

Conditions
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Out of Hospital Cardiac Arrest

Intervention / Treatment
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* Behavioral: Pre-hospital cooling


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Pre-hospital cooling<br>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<br>* 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.<br>|
| No Intervention: Usual pre-hospital care<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Therapeutic Hypothermia, Cardiac arrest