OPALS Critical Care Sub-Studies

Cardiac Arrest Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00212953
• Other study ID #: 1997576-01H
• Status: Completed
• Phase: N/A
• First received: September 13, 2005
• Last updated: October 13, 2010
• Start date: March 1997
• Est. completion date: May 1999

Study information

• Verified date: October 2010
• Source: Ottawa Hospital Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21000
• Est. completion date: May 1999
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cardiac Arrest
• Heart Arrest

Intervention

Procedure:
• Advanced Life Support

Locations

Country	Name	City	State
Canada	Cambridge Base Hospital	Cambridge	Ontario
Canada	Kingston Base Hospital	Kingston	Ontario
Canada	London Base Hospital	London	Ontario
Canada	Halton Base Hospital	Mississauga	Ontario
Canada	Niagara Falls Base Hospital	Niagara Falls	Ontario
Canada	Ottawa Base Hospital	Ottawa	Ontario
Canada	Peterborough Base Hospital	Peterborough	Ontario
Canada	Lambton Base Hospital	Sarnia	Ontario
Canada	Sudbury Base Hospital	Sudbury	Ontario
Canada	Thunder Bay Base Hospital	Thunder Bay	Ontario
Canada	Windsor Base Hospital	Windsor	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Ottawa Hospital Research Institute	Ontario Ministry of Health and Long Term Care

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival to discharge
Secondary	Generic Quality of Life
Secondary	Disease Specific Quality of Life CPC Score and FIM Score
Secondary	Performance of ALS Procedures
Secondary	Response Time Intervals
Secondary	Length of Stay in Hospital
Secondary	Length of Stay in Critical Care Units
Secondary	Ventilator time
Secondary	Disease Specific Quality of Life