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

Out of Hospital Cardiac Arrest Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01528475
• Other study ID #: ICE PACS
• Status: Completed
• Phase: N/A
• First received: October 31, 2011
• Last updated: December 16, 2016
• Start date: July 2012
• Est. completion date: June 2016

Study information

• Verified date: December 2016
• Source: Sunnybrook Health Sciences Centre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 585
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Heart Arrest
• Hypothermia
• Out of Hospital Cardiac Arrest
• Out-of-Hospital Cardiac Arrest

Intervention

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.

Locations

Country	Name	City	State
Canada	Peel Emergency Medical Services	Mississauga	Ontario
Canada	Halton Emergency Medical Services	Oakville	Ontario
Canada	Toronto Emergency Medical Services	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Sunnybrook Health Sciences Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Mortality at hospital discharge	Proportion of deaths at hospital discharge	Hospital discharge	No
Secondary	Mortality during transport	Proportion of patients that die after randomization and during transport to hospital.	During transport to hospital	Yes
Secondary	Mortality during 6 hours	Proportion of patients that die within 6 hours of emergency department arrival	Within 6 hours of emergency department arrival	Yes
Secondary	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	No
Secondary	Median Modified Rankin score at hospital discharge	The median modified Rankin score at hospital discharge	hospital discharge	No
Secondary	Good neurological outcome	The proportion of patients with Modified Rankin Scale = 0, 1, or 2 at hospital discharge.	hospital discharge	No
Secondary	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	Yes