OPALS Pediatric Study
Condition: Seizure
MeSH terms: Seizures
Study type: Interventional

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

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.
    

Intervention name(s): Advanced Life Support
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Single Group Assignment
Primary purpose: Treatment
Keywords: Pediatrics; Seizure; Trauma; Respiratory; Cardiac; Arrest