Prospective, randomized, controlled clinical trial comparing traditional versus reduced tidal volume ventilation in acute respiratory distress syndrome patients

Objective: To assess the safety and potential efficacy of a mechanical vent ilation strategy designed to reduce stretch-induced lung injury in acute re spiratory distress syndrome. Design: Prospective, randomized, controlled clinical trial. Setting: Eight intensive care units in four teaching hospitals. Patients: Fifty-two patients with acute respiratory distress syndrome. Interventions: Traditional tidal volume patients: tidal volume 10-12 mL/kg ideal body weight, reduced if inspiratory plateau pressure was >55 cm H2O ( 7.3 kPa). Small tidal volume patients: tidal volume 5-8 mL/kg ideal body we ight, to keep plateau pressure < 30 cm H2O (4.0 kPa). Measurements and Main Results: Mean tidal volumes during the first 5 days i n traditional and small tidal volume patients were 10.2 and 7.3 mL/kg, resp ectively (p < .001), with mean plateau pressure = 30.6 and 24.9 cmH(2)O (3. 3 kPa), respectively (p < .001). There were no significant differences in r equirements for positive end-expiratory pressure or Flo(2), fluid intakes/o utputs, requirements for vasopressors, sedatives, or neuromuscular blocking agents, percentage of patients that achieved unassisted breathing, ventila tor days, or mortality. Conclusions: The reduced tidal volume strategy used in this study was safe. Failure to observe beneficial effects of small tidal volume ventilation tr eatment in important clinical outcome variables may have occurred because a ) the sample size was too small to discern small treatment effects; b) the differences in tidal volumes and plateau pressures were modest; or c) reduc ed tidal volume ventilation is not beneficial.