Mechanical ventilation of patients with acute respiratory distress syndrome should balance lung and diaphragm protective principles, which may be difficult to achieve in routine clinical practice. Through a Phase I clinical trial, we sought to determine whether a computerized decision support–based protocol (real-time effort–driven ventilator management) is feasible to implement, results in improved acceptance for lung and diaphragm protective ventilation, and improves clinical outcomes over historical controls.
Interventional nonblinded pilot study.
Mechanically ventilated children with acute respiratory distress syndrome.
A computerized decision support tool was tested which prioritized lung-protective management of peak inspiratory pressure–positive end-expiratory pressure, positive end-expiratory pressure/Fio2, and ventilatory rate. Esophageal manometry was used to maintain patient effort in a physiologic range. Protocol acceptance was reported, and enrolled patients were matched 4:1 with respect to age, initial oxygenation index, and percentage of immune compromise to historical control patients for outcome analysis.
Measurements and Main Results:
Thirty-two patients were included. Acceptance of protocol recommendations was over 75%. One-hundred twenty-eight matched historical controls were used for analysis. Compared with historical controls, patients treated with real-time effort–driven ventilator management received lower peak inspiratory pressure–positive end-expiratory pressure and tidal volume, and higher positive end-expiratory pressure when Fio2 was greater than 0.60. Real-time effort–driven ventilator management was associated with 6 more ventilator-free days, shorter duration until the first spontaneous breathing trial and 3 fewer days on mechanical ventilation among survivors (all p ≤ 0.05) in comparison with historical controls, while maintaining no difference in the rate of reintubation.
A computerized decision support–based protocol prioritizing lung-protective ventilation balanced with reduction of controlled ventilation to maintain physiologic levels of patient effort can be implemented and may be associated with shorter duration of ventilation.