OPALS Pediatric Study

This study has been completed.
Sponsor:
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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 27, 2014