Design and implementation of a controlled trial of pediatric endotracheal intubation in the out-of-hospital setting.

This article describes the design and implementation of the Pediatric Airway Management Project. The project was completed January 1, 1997, and evaluated the effectiveness of endotracheal intubation relative to bag-valve-mask ventilation in improving survival to hospital discharge and neurologic outcome in children, the effect of training on paramedic airway management skills and self-efficacy, the length of time the skills can be retained, and the costs of training and retraining. The main focus of project design was the implementation of a controlled trial comparing methods of airway management for acutely ill and injured pediatric patients in the out-of-hospital setting. To date, this project is the largest prospective, controlled, out-of-hospital study of the care of children ever reported. Barriers to implementation of a study of this size are described.