OPALS Critical Care Sub-Studies

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00212953
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : October 15, 2010
Ontario Ministry of Health and Long Term Care
Information provided by:
Ottawa Hospital Research Institute

Brief Summary:
The purpose of the study is to evaluate the incremental benefit of a full advanced life support EMS program on the outcomes of chest pain, respiratory and major trauma patients.

Condition or disease Intervention/treatment Phase
Cardiac Arrest Procedure: Advanced Life Support Not Applicable

Study Type : Interventional  (Clinical Trial)
Enrollment : 21000 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Ontario Prehospital Advanced Life Support (OPALS) Study Phase III Cardiac Arrest and Critical Care Sub-Studies - Chest Pain Sub-Study, Respiratory Sub-Study, and Major Trauma Sub-Study
Study Start Date : March 1997
Actual Study Completion Date : May 1999

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Survival to discharge

Secondary Outcome Measures :
  1. Generic Quality of Life
  2. Disease Specific Quality of Life CPC Score and FIM Score
  3. Performance of ALS Procedures
  4. Response Time Intervals
  5. Length of Stay in Hospital
  6. Length of Stay in Critical Care Units
  7. Ventilator time
  8. Disease Specific Quality of Life

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Chest Pain Sub-Study: Adult patients with a complaint of chest pain of an acute nature transported to hospital by ambulance. Patients with a complaint of pain in arms, neck or jaw if consistent with myocardial ischemia. Patients must have an ambulance return code of prompt, urgent, or no patient carried.
  • Respiratory Sub-Study: Adult patients with a chief complaint of shortness of breath defined as ACR codes of Respiratory Failure, Shortness of Breath NYD, Pulmonary Edema (CHF), Asthma and had either prehospital assisted ventilation or abnormal respiratory rates (>=24 or <=10)
  • Major Trauma Sub-Study: Adult patients who have suffered an injury from any mechanism with an Injury Severity Score of >12 who have been transported to hospital by land ambulance, and who have been entered into the Ontario Trauma Registry (OTR) Comprehensive Data Set.

Exclusion Criteria:

  • All Sub-Studies:
  • Patients under the age of 16
  • Patients who are vital signs absent prior to EMS arrival.
  • Chest Pain Sub-Study:
  • Patients suffering primarily from respiratory distress, respiratory failure, pulmonary edema, asthma, palpitations or epigastric pain. pain

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00212953

Canada, Ontario
Cambridge Base Hospital
Cambridge, Ontario, Canada, N3C 3X4
Kingston Base Hospital
Kingston, Ontario, Canada, K7L 1S4
London Base Hospital
London, Ontario, Canada, N6A 4G5
Halton Base Hospital
Mississauga, Ontario, Canada, L6K 3S3
Niagara Falls Base Hospital
Niagara Falls, Ontario, Canada, L2E 6X2
Ottawa Base Hospital
Ottawa, Ontario, Canada, K1H 8L6
Peterborough Base Hospital
Peterborough, Ontario, Canada, K9J 7C6
Lambton Base Hospital
Sarnia, Ontario, Canada, N7T 6S3
Sudbury Base Hospital
Sudbury, Ontario, Canada, 705-675-4783
Thunder Bay Base Hospital
Thunder Bay, Ontario, Canada, P7E 1G6
Windsor Base Hospital
Windsor, Ontario, Canada, N9A 1E1
Sponsors and Collaborators
Ottawa Hospital Research Institute
Ontario Ministry of Health and Long Term Care
Principal Investigator: Ian Stiell, MD OHRI

Responsible Party: Ian Stiell, Principal Investigator, Ottawa Hospital Research Institute Identifier: NCT00212953     History of Changes
Other Study ID Numbers: 1997576-01H
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: October 15, 2010
Last Verified: October 2010

Keywords provided by Ottawa Hospital Research Institute:
Chest Pain,
Shortness of breath,

Additional relevant MeSH terms:
Heart Arrest
Heart Diseases
Cardiovascular Diseases