Cardiac ArrestNCT00212953
OPALS Critical Care Sub-Studies
A study testing Advanced Life Support in people with Cardiac Arrest, run by Ottawa Hospital Research Institute at 11 sites in Canada.
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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Cardiac Arrest
- What is being tested?
- Advanced Life Support
- Type of treatment
- Surgery or procedure
- How many people
- 21,000 participants
- Where
- 11 sitesCanada
- Study dates
- Mar 1997to May 1999
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
Canada11 sites
Cambridge Base Hospital
Cambridge, Ontario, N3C 3X4
Sudbury Base Hospital
Greater Sudbury, Ontario, 705-675-4783
Kingston Base Hospital
Kingston, Ontario, K7L 1S4
London Base Hospital
London, Ontario, N6A 4G5
Halton Base Hospital
Mississauga, Ontario, L6K 3S3
Niagara Falls Base Hospital
Niagara Falls, Ontario, L2E 6X2
Ottawa Base Hospital
Ottawa, Ontario, K1H 8L6
Peterborough Base Hospital
Peterborough, Ontario, K9J 7C6
Lambton Base Hospital
Sarnia, Ontario, N7T 6S3
Thunder Bay Base Hospital
Thunder Bay, Ontario, P7E 1G6
Windsor Base Hospital
Windsor, Ontario, N9A 1E1
About this study
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
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.
- Conditions
- Cardiac Arrest
- Being tested
- Advanced Life Support
- Keywords
- Chest Pain,, Shortness of breath,, Injury,, Trauma
- Medical subject headings
- Heart Arrest, Chest Pain, Dyspnea, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Advanced Life SupportProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival to discharge
Secondary outcomes (8)
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startMar 1997
- Study completionMay 1999
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac ArrestStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21,000 participants
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Ontario Ministry of Health and Long Term Care
- Investigators
- Ian Stiell, MD, Principal investigator, OHRI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00212953
- Sponsor's protocol ID
- 1997576-01H
- Status last verified
- Oct 2010
- First submitted
- 13 Sep 2005
- Last updated
- 15 Oct 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00212953
- Acronym / sponsor ID
- 1997576-01H
- Conditions
- Cardiac Arrest
- Keywords
- Chest Pain,, Shortness of breath,, Injury,, Trauma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21,000 participants
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Collaborators
- Ontario Ministry of Health and Long Term Care
- Study start
- Mar 1997
- Study completion
- May 1999 (actual)
- First posted
- 21 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Advanced Life Support | Procedure or surgery | – |
Primary outcome
Survival to discharge
8 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ian Stiell, MD principal investigator
OHRI
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Advanced Life Support in people with Cardiac Arrest, run by Ottawa Hospital Research Institute at 11 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival to discharge. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2010.