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

NCT01528475 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 585

Last updated 2016-12-19

No results posted yet for this study

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.

Conditions

  • Out of Hospital Cardiac Arrest

Interventions

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.

Sponsors & Collaborators

  • Sunnybrook Health Sciences Centre

    lead OTHER

Principal Investigators

  • Damon Scales, MD · Sunnybrook Hospital

  • Laurie Morrison, M.D. · Unity Health Toronto

  • Steven Brooks, M.D. · Clinical Scientist

  • Rick Verbeek, MD · Sunnybrook Centre for Prehospital Medicine

  • Sheldon Cheskes, MD · Sunnybrook Centre for Prehospital Medicine

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-07-31
Primary Completion
2016-06-30
Completion
2016-06-30

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01528475 on ClinicalTrials.gov