OPALS Critical Care Sub-Studies

This study has been completed.
Sponsor:
Collaborator:
Ontario Ministry of Health and Long Term Care
Information provided by:
Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier:
NCT00212953
First received: September 13, 2005
Last updated: October 13, 2010
Last verified: October 2010
  Purpose

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 Intervention
Cardiac Arrest
Procedure: Advanced Life Support

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Ottawa Hospital Research Institute:

Primary Outcome Measures:
  • Survival to discharge

Secondary Outcome Measures:
  • Generic Quality of Life
  • Disease Specific Quality of Life CPC Score and FIM Score
  • Performance of ALS Procedures
  • Response Time Intervals
  • Length of Stay in Hospital
  • Length of Stay in Critical Care Units
  • Ventilator time
  • Disease Specific Quality of Life

Estimated Enrollment: 21000
Study Start Date: March 1997
Study Completion Date: May 1999
  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00212953

Locations
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
Investigators
Principal Investigator: Ian Stiell, MD OHRI
  More Information

No publications provided

Responsible Party: Ian Stiell, Principal Investigator, Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT00212953     History of Changes
Other Study ID Numbers: 1997576-01H
Study First Received: September 13, 2005
Last Updated: October 13, 2010
Health Authority: Canada: Ethics Review Committee

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

Additional relevant MeSH terms:
Heart Arrest
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 22, 2014