OPALS Pediatric Study

NCT00298532 | Completed

• 1 other identifier: MOP 64269
• Study Type: interventional
• Target: 9,000
• Locations: 1 country
• Sites: 10

Brief Summary

The OPALS Pediatric Study will examine the incremental impact of introducing a prehospital full advanced life support in pediatric patients.

Conditions

Seizure

Keywords

Pediatrics; Seizure; Trauma; Respiratory; Cardiac; Arrest

Outcome Measures

Primary Outcomes (1)

• Survival to discharge Quality of life Response time intervals Performance of ALS intervals Emergency department interventions Admission rates Length of stay

Study Arms (1)

standard therapy

NO INTERVENTION

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

Interventions

Advanced Life Support PROCEDURE

standard therapy

Eligibility Criteria

• Age: 1 Day - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Patients less than 16 years of age transported to the Emergency Department with either seizure, acute trauma, respiratory distress or cardiac arrest.

You may not qualify if:

• Patients over 16 years of age or older.

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead
• Ontario Ministry of Health and Long Term Care: collaborator

Study Sites (10)

Cambrige Base Hospital

Cambridge, Ontario, N3C 3X4, Canada

Location

Sudbury Base Hospital

Greater Sudbury, Ontario, Canada

Location

Kingston Base Hospital

Kingston, Ontario, K7L 1S4, Canada

Location

London Base Hospital

London, Ontario, N6A 4G5, Canada

Location

Halton Base Hospital

Mississauga, Ontario, L6K 3S3, Canada

Location

Niagara Falls Base Hospital

Niagara Falls, Ontario, L2E 6X2, Canada

Location

Ottawa Base Hospital

Ottawa, Ontario, K1H 8L6, Canada

Location

Peterborough Base Hospital

Peterborough, Ontario, K9J 7C6, Canada

Location

Thunder Bay Regional Health Science Centre

Thunder Bay, Ontario, P7B 6V4, Canada

Location

Hotel Dieu Grace Hospital

Windsor, Ontario, N9A 1E1, Canada

Location

MeSH Terms

Conditions

Seizures; Wounds and Injuries; Heart Arrest

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Heart Diseases; Cardiovascular Diseases

Study Officials

• Ian Stiell, MD

  OHRI

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 1, 2006
• First Posted: March 2, 2006
• Study Start: July 1, 1992
• Primary Completion: January 1, 2007
• Study Completion: January 1, 2008
• Last Updated: October 15, 2010

Record last verified: 2010-10

Locations

CA (10)