OPALS Pediatric Study

The Ontario Prehospital Advanced Life Support (OPALS) Study for Critically Ill and Injured Pediatric Patients

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

Study Overview

• Status: Completed
• Conditions: Seizure
• Intervention / Treatment: Procedure: Advanced Life Support

Detailed Description

Background: Pediatric patients constitute a significant proportion of all ambulance transports by emergency medical services (EMS) with the most common conditions being trauma, respiratory distress, and seizures. Cardiopulmonary arrest is a less common condition but has a mortality rate in children in excess of 98%. Very little evidence is available regarding the effectiveness of prehospital interventions for children. Canadian communities require guidance as to whether their local EMS services should implement full advanced life support (ALS) measures for pediatric patients. This proposal builds upon the Adult OPALS Study, the largest controlled out-of-hospital study ever conducted worldwide, which is evaluating the impact of ALS programs in multiple Ontario cities on 35,000 adult patients.

Objectives: The goal of the Pediatric OPALS Study is to evaluate the benefit of introducing a prehospital program of full ALS measures (intubation and intravenous drug therapy) on the outcomes of critically ill and injured pediatric patients. Specific objectives are to determine the impact of this ALS program on mortality, other clinical outcomes, morbidity (quality of life), EMS response intervals, and cost-effectiveness for these critical conditions: a) Respiratory distress and obstruction, b) Seizure, c) Major trauma, and d) Cardio-pulmonary arrest. We hypothesize, for each of the four patient populations separately, that in the Intervention period: i) Mortality will be reduced (primary hypothesis); ii) Other Clinical Measures will be improved for other clinical outcomes, ED interventions, admission rates, and lengths of stay; iii) Quality of Life of survivors will be improved for both generic and disease-specific measures; iv) Response Time Intervals will not be increased; and, v) Economic Evaluation will reveal that the costs and effects are distributed more favourably.

Methods: The Pediatric OPALS Study will incorporate a before-after design with the unit of study being all eligible patients seen during each of two distinct 36-month periods in 17 Ontario cities. During the baseline Control (Before) Period (1992-1998), the study cities provided BLS-D level of care with first-responder firefighters and Primary Care Paramedics. During the Intervention (After) Period (1998-2002), the study cities provided a full pre-hospital ALS program. The study population is all patients under the age of 16 years who were treated out-of-hospital for any of these four conditions: a) Respiratory Distress or Obstruction, defined as patients with a chief complaint of shortness of breath, respiratory arrest, or airway obstruction; b) Seizure, defined as patients having suffered a generalized convulsion; c) Major Trauma, defined as patients with injuries caused by any mechanism and associated with an Injury Severity Score (ISS) more than 12; d) Cardiopulmonary Arrest, defined as patients with absence of a detectable pulse, unresponsiveness, and apnea. The study intervention was implemented during the "Run-in" period, immediately prior to the Intervention period, and entails a program of pre-hospital ALS care provided by EMS: a) Endotracheal Intubation, b) Intravenous therapy, and c) Administration of intravenous drugs. Study cities had to meet four strict performance criteria. Data will be obtained by electronic or hard copy means from the following sources: Ambulance Call Reports, Fire Medical Reports, Base Hospital Reviews, Ambulance Response Information System, Hospital Records, Ontario Trauma Registry, and Follow-up Interviews. The primary outcome measure will be mortality. Secondary outcomes include a) Other Clinical Measures (Other Survival, Need for Interventions in the ED, Admission, Lengths of Stay), b) Generic Quality of Life (HUI3), c) Disease-specific Quality of Life (CPC, FIM), d) Response Time Intervals, and g) Direct Costs. The primary data analysis will test the hypothesis that mortality discharge will be improved when comparing the after period to the before period by chi-square analysis techniques. Stepwise logistic regression analysis will be performed to control for the possible confounding effects of various indicators and to assess the effect of the study period on survival. The study will involve a total of 18,000 pediatric patients over 72 months.

Importance: This proposed study has a unique opportunity to evaluate the effectiveness of ALS interventions on the outcomes of critically ill and injured patients. Never again may there be such an opportunity to conduct a controlled evaluation of the impact of an ALS program in such a large population. The results of this study will be very important to health care planners in Canada and throughout the world.

• Study Type: Interventional
• Enrollment: 9000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Cambridge, Ontario, Canada, N3C 3X4
      • Cambrige Base Hospital
    • Kingston, Ontario, Canada, K7L 1S4
      • Kingston Base Hospital
    • London, Ontario, Canada, N6A 4G5
      • London Base Hospital
    • Mississauga, Ontario, Canada, L6K 3S3
      • Halton Base Hospital
    • Niagara Falls, Ontario, Canada, L2E 6X2
      • Niagara Falls Base Hospital
    • Ottawa, Ontario, Canada, K1H 8L6
      • Ottawa Base Hospital
    • Peterborough, Ontario, Canada, K9J 7C6
      • Peterborough Base Hospital
    • Sudbury, Ontario, Canada
      • Sudbury Base Hospital
    • Thunder Bay, Ontario, Canada, P7B 6V4
      • Thunder Bay Regional Health Science Centre
    • Windsor, Ontario, Canada, N9A 1E1
      • Hotel Dieu Grace Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 15 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: SINGLE_GROUP

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Ottawa Hospital Research Institute
• Collaborators: Ontario Ministry of Health and Long Term Care

Study record dates

Study Major Dates

• Study Start: July 1, 1992
• Primary Completion (ACTUAL): January 1, 2007
• Study Completion (ACTUAL): January 1, 2008

Study Registration Dates

• First Submitted: March 1, 2006
• First Submitted That Met QC Criteria: March 1, 2006
• First Posted (ESTIMATE): March 2, 2006

Study Record Updates

• Last Update Posted (ESTIMATE): October 15, 2010
• Last Update Submitted That Met QC Criteria: October 13, 2010
• Last Verified: October 1, 2010

More Information

Terms related to this study

• Keywords: Pediatrics; Trauma; Cardiac; Respiratory; Seizure; Arrest
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Seizures
• Other Study ID Numbers: MOP 64269