Clinical trial NCT00212953: 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
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Arrest
Keywords: Chest Pain,
Shortness of breath,
Injury,
Trauma
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
Collaborators: name: Ontario Ministry of Health and Long Term Care
First posted: 2005-09-21
Enrollment: 21000
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


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 (\&gt;=24 or \&lt;=10)
* Major Trauma Sub-Study: Adult patients who have suffered an injury from any mechanism with an Injury Severity Score of \&gt;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

Primary outcomes:
measure: Survival to discharge
Secondary outcomes:
measure: Generic Quality of Life
measure: Disease Specific Quality of Life CPC Score and FIM Score
measure: Performance of ALS Procedures
measure: Response Time Intervals
measure: Length of Stay in Hospital
measure: Length of Stay in Critical Care Units
measure: Ventilator time
measure: Disease Specific Quality of Life
Other outcomes:
Locations:
city: Cambridge
country: Canada
facility: Cambridge Base Hospital
state: Ontario
city: Kingston
country: Canada
facility: Kingston Base Hospital
state: Ontario
city: London
country: Canada
facility: London Base Hospital
state: Ontario
city: Mississauga
country: Canada
facility: Halton Base Hospital
state: Ontario
city: Niagara Falls
country: Canada
facility: Niagara Falls Base Hospital
state: Ontario
city: Ottawa
country: Canada
facility: Ottawa Base Hospital
state: Ontario
city: Peterborough
country: Canada
facility: Peterborough Base Hospital
state: Ontario
city: Sarnia
country: Canada
facility: Lambton Base Hospital
state: Ontario
city: Sudbury
country: Canada
facility: Sudbury Base Hospital
state: Ontario
city: Thunder Bay
country: Canada
facility: Thunder Bay Base Hospital
state: Ontario
city: Windsor
country: Canada
facility: Windsor Base Hospital
state: Ontario
Study officials:
affiliation: OHRI
name: Ian Stiell, MD
role: PRINCIPAL_INVESTIGATOR
References: