OPALS Pediatric Study
This study has been completed.
Sponsor:
Ottawa Hospital Research Institute
Collaborator:
Ontario Ministry of Health and Long Term Care
Information provided by:
Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier:
NCT00298532
First received: March 1, 2006
Last updated: October 13, 2010
Last verified: October 2010
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Purpose
The OPALS Pediatric Study will examine the incremental impact of introducing a prehospital full advanced life support in pediatric patients.
| Condition | Intervention |
|---|---|
|
Seizure |
Procedure: Advanced Life Support |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Single Group Assignment Primary Purpose: Treatment |
| Official Title: | The Ontario Prehospital Advanced Life Support (OPALS) Study for Critically Ill and Injured Pediatric Patients |
Resource links provided by NLM:
Genetics Home Reference related topics:
pyridoxal 5'-phosphate-dependent epilepsy
MedlinePlus related topics:
Seizures
U.S. FDA Resources
Further study details as provided by Ottawa Hospital Research Institute:
Primary Outcome Measures:
- Survival to discharge Quality of life Response time intervals Performance of ALS intervals Emergency department interventions Admission rates Length of stay
| Estimated Enrollment: | 9000 |
| Study Start Date: | July 1992 |
| Study Completion Date: | January 2008 |
| Primary Completion Date: | January 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
No Intervention: standard therapy
The use of a before-after controlled study design and 36-month time periods will mirror the approach of our Adult OPALS Study. The Control (before) Period represents the 36 months immediately prior to the introduction of ALS programs at each study community. The Intervention (after) Period is comprised of the 36 months immediately after each community has met all standards for a full ALS program, as defined below. Data will be pooled across communities but the start date for the periods will vary for each community as each will require different amounts of time to prepare their ALS program. A 6- to 36-month "Run-in" period will separate the Control and Intervention Periods and will allow for training and implementation of the ALS program. Data from the Run-in period will not be considered in the primary analysis. The study periods may be summarized as follows: a) Control (Before) Period b) Run-in Period c) Intervention (After) Period.
|
Procedure: Advanced Life Support |
Show Detailed Description Eligibility| Ages Eligible for Study: | up to 15 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients less than 16 years of age transported to the Emergency Department with either seizure, acute trauma, respiratory distress or cardiac arrest.
Exclusion Criteria:
- Patients over 16 years of age or older.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00298532
Locations
| Canada, Ontario | |
| Cambrige Base Hospital | |
| Cambridge, Ontario, Canada, N3C 3X4 | |
| Kingston Base Hospital | |
| Kingston, Ontario, Canada, K7L 1S4 | |
| London Base Hospital | |
| London, Ontario, Canada, N6A 4G5 | |
| Halton Base Hospital | |
| Mississauga, Ontario, Canada, L6K 3S3 | |
| Niagara Falls Base Hospital | |
| Niagara Falls, Ontario, Canada, L2E 6X2 | |
| Ottawa Base Hospital | |
| Ottawa, Ontario, Canada, K1H 8L6 | |
| Peterborough Base Hospital | |
| Peterborough, Ontario, Canada, K9J 7C6 | |
| Sudbury Base Hospital | |
| Sudbury, Ontario, Canada | |
| Thunder Bay Regional Health Science Centre | |
| Thunder Bay, Ontario, Canada, P7B 6V4 | |
| Hotel Dieu Grace Hospital | |
| Windsor, Ontario, Canada, N9A 1E1 | |
Sponsors and Collaborators
Ottawa Hospital Research Institute
Ontario Ministry of Health and Long Term Care
Investigators
| Principal Investigator: | Ian Stiell, MD | OHRI |
More Information
No publications provided
| Responsible Party: | Ian G. Stiell, Principal Investigator, Ottawa Hospital Research Institute |
| ClinicalTrials.gov Identifier: | NCT00298532 History of Changes |
| Other Study ID Numbers: | MOP 64269 |
| Study First Received: | March 1, 2006 |
| Last Updated: | October 13, 2010 |
| Health Authority: | Canada: Ethics Review Committee |
Keywords provided by Ottawa Hospital Research Institute:
|
Pediatrics Seizure Trauma |
Respiratory Cardiac Arrest |
Additional relevant MeSH terms:
|
Seizures Epilepsy Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Neurologic Manifestations Signs and Symptoms |
ClinicalTrials.gov processed this record on May 22, 2013