OPALS Critical Care Sub-Studies

October 13, 2010 updated by: Ottawa Hospital Research Institute

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

21000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Cambridge, Ontario, Canada, N3C 3X4
        • Cambridge Base Hospital
      • Kingston, Ontario, Canada, K7L 1S4
        • Kingston Base Hospital
      • London, Ontario, Canada, N6A 4G5
        • London Base Hospital
      • Mississauga, Ontario, Canada, L6K 3S3
        • Halton Base Hospital
      • Niagara Falls, Ontario, Canada, L2E 6X2
        • Niagara Falls Base Hospital
      • Ottawa, Ontario, Canada, K1H 8L6
        • Ottawa Base Hospital
      • Peterborough, Ontario, Canada, K9J 7C6
        • Peterborough Base Hospital
      • Sarnia, Ontario, Canada, N7T 6S3
        • Lambton Base Hospital
      • Sudbury, Ontario, Canada, 705-675-4783
        • Sudbury Base Hospital
      • Thunder Bay, Ontario, Canada, P7E 1G6
        • Thunder Bay Base Hospital
      • Windsor, Ontario, Canada, N9A 1E1
        • Windsor Base Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Survival to discharge

Secondary Outcome Measures

Outcome Measure
Disease Specific Quality of Life
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ottawa Hospital Research Institute

Collaborators

Ontario Ministry of Health and Long Term Care

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 1997

Study Completion (Actual)

May 1, 1999

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 21, 2005

Study Record Updates

Last Update Posted (Estimate)

October 15, 2010

Last Update Submitted That Met QC Criteria

October 13, 2010

Last Verified

October 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1997576-01H

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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