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NCT Number: NCT01528475

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Peel Emergency Medical Services, Mississauga, Ontario, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Success of in-hospital cooling

    Time frame: 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 outcomes

  1. Mortality at hospital discharge

    Time frame: Hospital discharge

    Proportion of deaths at hospital discharge

  2. Mortality during transport

    Time frame: During transport to hospital

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

  3. Mortality during 6 hours

    Time frame: Within 6 hours of emergency department arrival

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

  4. Cooling ever in hospital

    Time frame: 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

  5. Median Modified Rankin score at hospital discharge

    Time frame: hospital discharge

    The median modified Rankin score at hospital discharge

  6. Good neurological outcome

    Time frame: hospital discharge

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

  7. Time of transport to hospital

    Time frame: During transport to hospital

    Mean time (minutes) from arrival of paramedics on the scene to arrival and transport of patient to emergency department.

Sponsors and collaborators

Lead sponsor

Sunnybrook Health Sciences Centre

Other

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Feb 8, 2012
Registry last updated
Dec 19, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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