CLINICAL TRIAL
JOURNAL ARTICLE
RANDOMIZED CONTROLLED TRIAL
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Weaning children from mechanical ventilation: a prospective randomized trial of protocol-directed versus physician-directed weaning.

Respiratory Care 2001 August
OBJECTIVE: Compare outcomes between physician-directed and protocol-directed weaning from mechanical ventilation in pediatric patients.

DESIGN: Prospective-randomized.

SETTING: Pediatric and cardiac intensive care units in a 307-bed tertiary referral hospital for children.

INTERVENTIONS: The control group (physician-directed) was weaned according to individual physician order for reduction in minute ventilation, positive end-expiratory pressure, and ordered oxygen saturation parameters for reduction in fraction of inspired oxygen (F(IO)(2)). The study group (protocol-directed) was weaned according to a predetermined algorithm developed for the purpose of this investigation.

METHODS: The study enrolled 223 patients (116 physician-directed, 107 protocol-directed). All patients were monitored for hemodynamics, ventilator parameters, arterial blood gas values when available, oxygen saturation, weaning time, pre-weaning time, extubation time, and time on F(IO)(2) > or = 0.40. We also monitored the incidence of reintubation, subglottic stenosis, tracheitis, and pneumonia. The protocol-directed group had additional measurements of actual versus predicted minute volume, comparisons of respiratory rate (actual versus predicted for age), and presence of spontaneous breathing effort for 10 consecutive minutes. Data analysis was done according to intent to treat.

RESULTS: There was no significant difference in 12-hour and 24-hour pediatric risk of mortality (PRISM III) scores between groups. The protocol-directed group overall had shorter total ventilation time, weaning time, pre-weaning time, time to extubation, and time on F(IO)(2) >0.40, although after stratification for respiratory diagnosis, only the difference in weaning time remained significant. There was no difference in the incidence of reintubation, new-onset tracheitis, subglottic stenosis, or pneumonia.

CONCLUSIONS: Protocol-directed weaning resulted in a shorter weaning time than physician-directed weaning in these pediatric patients.

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