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OPALS Critical Care Sub-Studies

Primary Purpose

Cardiac Arrest

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Advanced Life Support
Sponsored by
Ottawa Hospital Research Institute
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cardiac Arrest focused on measuring Chest Pain,, Shortness of breath,, Injury,, Trauma

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cambridge Base Hospital
  • Kingston Base Hospital
  • London Base Hospital
  • Halton Base Hospital
  • Niagara Falls Base Hospital
  • Ottawa Base Hospital
  • Peterborough Base Hospital
  • Lambton Base Hospital
  • Sudbury Base Hospital
  • Thunder Bay Base Hospital
  • Windsor Base Hospital

Outcomes

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

Full Information

First Posted
September 13, 2005
Last Updated
October 13, 2010
Sponsor
Ottawa Hospital Research Institute
Collaborators
Ontario Ministry of Health and Long Term Care
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1. Study Identification

Unique Protocol Identification Number
NCT00212953
Brief Title
OPALS Critical Care Sub-Studies
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 Type
Interventional

2. Study Status

Record Verification Date
October 2010
Overall Recruitment Status
Completed
Study Start Date
March 1997 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 1999 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Ottawa Hospital Research Institute
Collaborators
Ontario Ministry of Health and Long Term Care

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Arrest
Keywords
Chest Pain,, Shortness of breath,, Injury,, Trauma

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
21000 (false)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Advanced Life Support
Primary Outcome Measure Information:
Title
Survival to discharge
Secondary Outcome Measure Information:
Title
Generic Quality of Life
Title
Disease Specific Quality of Life CPC Score and FIM Score
Title
Performance of ALS Procedures
Title
Response Time Intervals
Title
Length of Stay in Hospital
Title
Length of Stay in Critical Care Units
Title
Ventilator time
Title
Disease Specific Quality of Life

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ian Stiell, MD
Organizational Affiliation
OHRI
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cambridge Base Hospital
City
Cambridge
State/Province
Ontario
ZIP/Postal Code
N3C 3X4
Country
Canada
Facility Name
Kingston Base Hospital
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 1S4
Country
Canada
Facility Name
London Base Hospital
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4G5
Country
Canada
Facility Name
Halton Base Hospital
City
Mississauga
State/Province
Ontario
ZIP/Postal Code
L6K 3S3
Country
Canada
Facility Name
Niagara Falls Base Hospital
City
Niagara Falls
State/Province
Ontario
ZIP/Postal Code
L2E 6X2
Country
Canada
Facility Name
Ottawa Base Hospital
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Facility Name
Peterborough Base Hospital
City
Peterborough
State/Province
Ontario
ZIP/Postal Code
K9J 7C6
Country
Canada
Facility Name
Lambton Base Hospital
City
Sarnia
State/Province
Ontario
ZIP/Postal Code
N7T 6S3
Country
Canada
Facility Name
Sudbury Base Hospital
City
Sudbury
State/Province
Ontario
ZIP/Postal Code
705-675-4783
Country
Canada
Facility Name
Thunder Bay Base Hospital
City
Thunder Bay
State/Province
Ontario
ZIP/Postal Code
P7E 1G6
Country
Canada
Facility Name
Windsor Base Hospital
City
Windsor
State/Province
Ontario
ZIP/Postal Code
N9A 1E1
Country
Canada

12. IPD Sharing Statement

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OPALS Critical Care Sub-Studies

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