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CompletedNCT00370461Updated Nov 17, 2015

Basic Life Support Termination of Resuscitation Implementation Study

An observational study in Cardiac Arrest, sponsored by Sunnybrook Health Sciences Centre. Completed at 7 sites in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-11-17.

Sponsored by Sunnybrook Health Sciences Centre · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
350
Ages
18 Years and older
Sex
All
01

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

If all of these criteria are true, the PCP will contact the hospital and the decision by the emergency physician will then be made to stop life saving measures (terminate resuscitation) in the home or continue with life support and transport the patient to the local emergency department.

This study aims to document the usefulness of the termination of the resuscitation guideline in decreasing the rate of transport of out-of-hospital cardiac arrest patients to the ED. Secondary aims of this implementation study will be to describe the rates of erroneous application of the guideline. The comfort of use of the rule among paramedics and base hospital emergency physicians will be described.

Read the detailed description

In Ontario, most victims of out-of-hospital cardiac arrest (OHCA) do not receive Advanced Cardiac Life Support (ACLS); rather, they receive only Basic Life Support (BLS) from Primary Care Paramedics (PCPs), where the survival rate is approximately 5%. Every one of these patients is transported to the Emergency Department (ED), where the vast majority are pronounced dead. Conversely, patients who do not respond to ACLS by Advanced Care Paramedics (ACPs) are pronounced dead in the field via patching to the Base Hospital Physician (BHP). Implementation of a termination of resuscitation (TOR) guideline for the PCP's use would decrease the number of non-viable patients transported to the ED.

A reduction of unsuccessfully resuscitated cardiac arrest patients transported to the ED would have numerous advantages. First, it may improve the efficiency of the ED health care system because cardiac arrest patients in the ED require immediate attention that is diverted from potentially more salvageable patients. 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 EMS personnel. Additionally, it is less expensive to pronounce non-viable patients in the field. And, finally termination of resuscitative efforts in the field permits the paramedic to turn his attention and skill set to supporting the family through the initial stages of grief.

The most recent American Heart Association (AHA) emergency cardiac care guidelines suggest that there is a need to develop TOR protocols for PCPs in situations where ACLS care is not rapidly available, and call for more scientific evidence to support the implementation of such guidelines.

We derived and prospectively validated a clinical prediction rule to guide PCP termination of resuscitation in out of hospital cardiac arrest.

The TOR implementation study aims to document the usefulness of the TOR guideline, as specified by a newly developed medical directive, in decreasing the rate of transport of OHCA patients to the ED. Secondary aims of this implementation study will be to describe the rates of erroneous application of the guideline. The comfort of use of the rule among paramedics and base hospital emergency physicians will be described.

This will be a multi-centre prospective implementation study involving a combination of urban and rural regional EMS systems across Ontario. Included will be consecutive patients who suffer from non-traumatic cardiac arrest (i.e. of presumed cardiac etiology). Identical to the derivation and validation phase, patients will be excluded from the study if: their arrest is due to trauma, drowning or drug overdose; they receive any prehospital ACLS care; they possess a documented "Do Not Resuscitate" directive; or they are less than 18 years of age.

Cases that meet inclusion criteria will be enrolled consecutively. For each cardiac arrest, paramedics will respond to the call as usual and initiate resuscitation attempts. Patients suffering from cardiac arrest that (1) was not witnessed by EMS personnel; (2) had no shocks delivered by anyone; and (3) have had no return of spontaneous carotid or femoral pulse meet the criteria for TOR. In these circumstances PCPs will patch to the local BHP using the standard patching process. The BHP will then direct the paramedic to either continue resuscitation and transport, or terminate resuscitation in the field based on the TOR guideline and their clinical judgment of each individual call. In the case of failure of the paramedic to reach the BHP, the paramedic is directed to continue resuscitation and transport as per normal procedures, regardless of what the TOR guideline recommends. Data for each case will be requested from both the paramedic and the emergency physician using a uniform data collection sheet and the standardized Ontario Ambulance Call Report (ACR).

The rate of patient transport to the ED will be calculated. The obtained rate of transport will be compared to the theoretical rate obtained in the validation study, 37.4% using a one sample test, two sided, test of proportions, in order to evaluate the utility of the rule to decrease transport rates. Rates of erroneous application of the rule by both paramedics and emergency physicians will be calculated by identifying and tabulating the various reason for non-compliance. Occurrence of adverse patient outcomes, such as ROSC after TOR will be closely monitored.

02

Conditions studied

  • Cardiac Arrest

Keywords

  • Basic Cardiac Life Support
  • Termination of Resuscitation
  • Emergency Medical Services
  • Primary Care Paramedics
  • Out of Hospital Cardiac Arrest
03

In context

Heart Arrest

984 studies on the registry are indexed under Heart Arrest; 227 are open to participants now.

This study's enrollment of 350 is above the median of 196 across 394 observational studies indexed under Heart Arrest.

Browse Heart Arrest studies →

Lead sponsor

Sunnybrook Health Sciences Centre is the lead sponsor of 582 studies on the registry; 133 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability 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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
350 participants (actual)
06

Study locations

7 sites
  • Royal Victoria Hospital
    Barrie, Ontario L4N 1K4, Canada
  • Cornwall Community Hospital
    Cornwall, Ontario K6H 1Z6, Canada
  • Hamilton Health Sciences
    Hamilton, Ontario L8V 1C3, Canada
  • Grey Bruce Huron
    Owen Sound, Ontario N4K 6M9, Canada
  • Peterborough Regional Health Center
    Peterborough, Ontario K9J 7C6, Canada
  • Sault Area Hospital
    Sault Ste. Marie, Ontario P6A 2C4, Canada
  • Timmins and District Hospital
    Timmins, Ontario P4N 8P2, Canada
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References and documents

Publications

  • 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. PubMed 16885551 ↗
  • 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. PubMed 12093706 ↗
  • 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. PubMed 12782524 ↗
  • 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. PubMed 17303311 ↗
  • 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. PubMed 17383072 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 17, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00370461
Responsible party
Dr. Laurie Morrison (Clinician Scientist, Sunnybrook Health Sciences Centre) — Principal investigator
First posted
Aug 31, 2006
Start date
Jan 2006
Primary completion
Dec 2010
Completion
Jun 2012
Last update
Nov 17, 2015

Study contacts

Laurie J Morrison, MD
principal investigator · Rescu, St. Michael's Hospital Toronto
Richard P Verbeek, MD
principal investigator · Division of Emergency Medicine, Department of Medicine, University of Toronto and Sunnybrook Osler Center for Prehospital Care
Don Eby, MD
principal investigator · Grey Bruce Huron Paramedic Base Hospital Program, Grey Bruce Health Services, Owen Sound Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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