OPALS Critical Care Sub-Studies

Sponsor

Ottawa Hospital Research Institute (Other)

Overall Status

Completed

CT.gov ID

NCT00212953

Collaborator

Ontario Ministry of Health and Long Term Care (Other)

21,000

Enrollment

Locations

Duration (Months)

1909.1

Patients Per Site

73.5

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Cardiac Arrest	Procedure: Advanced Life Support	N/A

Study Design

Study Type:

Interventional

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 :

Mar 1, 1997

Actual Study Completion Date :

May 1, 1999

Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cambridge Base Hospital	Cambridge	Ontario	Canada	N3C 3X4
2	Kingston Base Hospital	Kingston	Ontario	Canada	K7L 1S4
3	London Base Hospital	London	Ontario	Canada	N6A 4G5
4	Halton Base Hospital	Mississauga	Ontario	Canada	L6K 3S3
5	Niagara Falls Base Hospital	Niagara Falls	Ontario	Canada	L2E 6X2
6	Ottawa Base Hospital	Ottawa	Ontario	Canada	K1H 8L6
7	Peterborough Base Hospital	Peterborough	Ontario	Canada	K9J 7C6
8	Lambton Base Hospital	Sarnia	Ontario	Canada	N7T 6S3
9	Sudbury Base Hospital	Sudbury	Ontario	Canada	705-675-4783
10	Thunder Bay Base Hospital	Thunder Bay	Ontario	Canada	P7E 1G6
11	Windsor Base Hospital	Windsor	Ontario	Canada	N9A 1E1