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Cardiac ArrestNCT00370461

Basic Life Support Termination of Resuscitation Implementation Study

An observational study of Cardiac Arrest, run by Sunnybrook Health Sciences Centre at 7 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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%. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cardiac Arrest
How many people
350 participants
Where
7 sitesCanada
Study dates
Jan 2006to Jun 2012
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

Canada7 sites
  • Royal Victoria Hospital

    Barrie, Ontario, L4N 1K4

  • Cornwall Community Hospital

    Cornwall, Ontario, K6H 1Z6

  • Hamilton Health Sciences

    Hamilton, Ontario, L8V 1C3

  • Grey Bruce Huron

    Owen Sound, Ontario, N4K 6M9

  • Peterborough Regional Health Center

    Peterborough, Ontario, K9J 7C6

  • Sault Area Hospital

    Sault Ste. Marie, Ontario, P6A 2C4

  • Timmins and District Hospital

    Timmins, Ontario, P4N 8P2

Other trials in Canada

About this study

Official title: Basic Life Support Termination of Resuscitation in the Prehospital Environment for Primary Care Paramedics - A Prospective Observational Study of the Implementation of a Clinical Prediction Rule

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.

Read more

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.

Conditions
Cardiac Arrest
Keywords
Basic Cardiac Life Support, Termination of Resuscitation, Emergency Medical Services, Primary Care Paramedics, Out of Hospital Cardiac Arrest
Medical subject headings
Heart Arrest, Out-of-Hospital Cardiac Arrest

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Aug 2006 (estimated)
  2. Study startJan 2006
  3. Primary completionDec 2010
  4. Study completionJun 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
350 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00370461
Sponsor's protocol ID
MOP67110
Status last verified
Nov 2015
First submitted
29 Aug 2006
Last updated
17 Nov 2015
Results posted
No
Data monitoring committee
No

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

Questions about this trial

What is this clinical trial studying?

An observational study of Cardiac Arrest, run by Sunnybrook Health Sciences Centre at 7 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00370461, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2015.

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