NCT00370461

Brief Summary

In Ontario, most people who experience a cardiac arrest at home (when their heart stops beating) only receive basic life support from Primary Care Paramedics (PCPs) and all are transported to the hospital. Most are pronounced dead by the emergency physician as the mean survival rate for these patients is 5%. Allowing Primary Care Paramedics to use a termination of resuscitation guideline would identify futile cases for which further resuscitation is unwarranted and decrease the number of patients being transported to the emergency department (ED) for pronouncement. There are numerous advantages to this strategy; first, it may improve the efficiency of the ED because cardiac arrest patients require immediate attention that is diverted from patients who have a better chance at survival. Second, the risk of injury and the monetary costs for the paramedic and the public would be minimized with fewer "light and sirens" transports which are known to be hazardous to motorists, pedestrians, and Emergency Medical Services (EMS) personnel. For each cardiac arrest, PCPs will respond to the call as usual and implement standard basic life support cardiac arrest protocols. Patients are then categorized according to the termination of resuscitation recommendations:

  1. 1.no return of spontaneous circulation is achieved (no heartbeat);
  2. 2.no shock was given prior to transport; and
  3. 3.the arrest (when the heart stops beating) was not witnessed by EMS personnel.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
350

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2006

Longer than P75 for all trials

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 29, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 31, 2006

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

November 17, 2015

Status Verified

November 1, 2015

Enrollment Period

4.9 years

First QC Date

August 29, 2006

Last Update Submit

November 16, 2015

Conditions

Keywords

Basic Cardiac Life SupportTermination of ResuscitationEmergency Medical ServicesPrimary Care ParamedicsOut of Hospital Cardiac Arrest

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

This is a multi centre prospective observational study of the implementatiaon of a Basic Life Support Termination of Resuscitation(BLS TOR)guideline.The study will accrue all out of hospital cardiac arrest cases from 9 regions across the province of Ontario(Cornwall, Hamilton,Peel, Peterborough, Grey Bruce Huron, Timmins, Sault Ste Marie, Simcoe/Muskoka, Cambridge). There are 22 participating EMS systems over the 9 regions.

You may qualify if:

  • Age \> 18
  • No advanced cardiac life support procedures (ACLS) were available during the call
  • The cardiac arrest is of presumed cardiac cause only

You may not qualify if:

  • Age \< 18
  • The patient possesses a documented do-not-resuscitate (DNR) order
  • The cardiac arrest is due to non cardiac causes such as trauma, drowning or drug overdose
  • Patient receives any prehospital ACLS care

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Royal Victoria Hospital

Barrie, Ontario, L4N 1K4, Canada

Location

Cornwall Community Hospital

Cornwall, Ontario, K6H 1Z6, Canada

Location

Hamilton Health Sciences

Hamilton, Ontario, L8V 1C3, Canada

Location

Grey Bruce Huron

Owen Sound, Ontario, N4K 6M9, Canada

Location

Peterborough Regional Health Center

Peterborough, Ontario, K9J 7C6, Canada

Location

Sault Area Hospital

Sault Ste. Marie, Ontario, P6A 2C4, Canada

Location

Timmins and District Hospital

Timmins, Ontario, P4N 8P2, Canada

Location

Related Publications (5)

  • Morrison LJ, Visentin LM, Kiss A, Theriault R, Eby D, Vermeulen M, Sherbino J, Verbeek PR; TOR Investigators. Validation of a rule for termination of resuscitation in out-of-hospital cardiac arrest. N Engl J Med. 2006 Aug 3;355(5):478-87. doi: 10.1056/NEJMoa052620.

    PMID: 16885551BACKGROUND
  • Verbeek PR, Vermeulen MJ, Ali FH, Messenger DW, Summers J, Morrison LJ. Derivation of a termination-of-resuscitation guideline for emergency medical technicians using automated external defibrillators. Acad Emerg Med. 2002 Jul;9(7):671-8. doi: 10.1111/j.1553-2712.2002.tb02144.x.

    PMID: 12093706BACKGROUND
  • Morrison LJ, Cheung MC, Redelmeier DA. Evaluating paramedic comfort with field pronouncement: development and validation of an outcome measure. Acad Emerg Med. 2003 Jun;10(6):633-7. doi: 10.1111/j.1553-2712.2003.tb00047.x.

    PMID: 12782524BACKGROUND
  • Morrison LJ, Visentin LM, Vermeulen M, Kiss A, Theriault R, Eby D, Sherbino J, Verbeek R; TOR investigators. Inter-rater reliability and comfort in the application of a basic life support termination of resuscitation clinical prediction rule for out of hospital cardiac arrest. Resuscitation. 2007 Jul;74(1):150-7. doi: 10.1016/j.resuscitation.2006.10.030. Epub 2007 Feb 14.

    PMID: 17303311BACKGROUND
  • Morrison LJ, Verbeek PR, Vermeulen MJ, Kiss A, Allan KS, Nesbitt L, Stiell I. Derivation and evaluation of a termination of resuscitation clinical prediction rule for advanced life support providers. Resuscitation. 2007 Aug;74(2):266-75. doi: 10.1016/j.resuscitation.2007.01.009. Epub 2007 Mar 23.

    PMID: 17383072BACKGROUND

MeSH Terms

Conditions

Heart ArrestOut-of-Hospital Cardiac Arrest

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Laurie J Morrison, MD

    Rescu, St. Michael's Hospital Toronto

    PRINCIPAL INVESTIGATOR
  • Richard P Verbeek, MD

    Division of Emergency Medicine, Department of Medicine, University of Toronto and Sunnybrook Osler Center for Prehospital Care

    PRINCIPAL INVESTIGATOR
  • Don Eby, MD

    Grey Bruce Huron Paramedic Base Hospital Program, Grey Bruce Health Services, Owen Sound Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinician Scientist

Study Record Dates

First Submitted

August 29, 2006

First Posted

August 31, 2006

Study Start

January 1, 2006

Primary Completion

December 1, 2010

Study Completion

June 1, 2012

Last Updated

November 17, 2015

Record last verified: 2015-11

Locations