Purpose: Duration of weaning from mechanical ventilation is decreased with the use of written protocols in adults. In children, the use of written protocols has not had such an impact.
Methods and measurements: We conducted a single-center trial to assess the feasibility of conducting a multicenter randomized clinical trial comparing the duration of weaning from mechanical ventilation in those managed by a computer-driven explicit protocol versus usual care. Mechanically ventilated children aged between 2 and 17 years on pressure support and not receiving inotropes were included. After randomization, children were weaned either by usual care (n = 15) that was characterized by no protocolized decisions by attending physicians, or by a computer-driven protocol (Smartcare/PS™, Drager Medical) (n = 15). Weaning duration until first extubation was the primary outcome. For comparison, a Mann-Whitney U test was employed (p < 0.05).
Results: Patients characteristics at inclusion were similar. The median duration of weaning was 21 h (range 3-142 h) in the SmartCare/PS™ group and 90 h (range 4-552 h) in the usual care group, p = 0.007. The rate of reintubation within 48 h after extubation and the rate of noninvasive ventilation after extubation in the SmartCare/PS™ and usual care groups were 2/15 versus 1/15 and 2/15 versus 2/15, respectively.
Conclusions: A pediatric randomized trial on mechanical ventilation with a computerized protocol in North America is feasible. A computer-driven protocol that also manages children younger than 2 years old would help to decrease the number of PICU admissions screened in a multicentre trial on this topic.
Trial registration: ClinicalTrials.gov NCT00678912.