Use of initial tidal volumes less than 8 ml/kg PBW is common at hospitals participating in the NHLBI PETAL Network. After considering the size and budgetary requirement for a cluster-randomized trial of LTVV vs. usual care in acute respiratory failure (ARF), the PETAL network deemed the proposed trial infeasible. A rapid observational study and simulations to model anticipated power may help better design trials. We included 2484 newly mechanically ventilated patients (31% with ARDS) from 49 hospitals. Hospital mortality was 28%. Mean initial tidal volume was 7.1 mL/kg predicted body weight (PBW) (95% CI 7.1-7.2) with 78% of patients receiving tidal volumes ≤ 8 mL/kg. We prospectively enrolled consecutive patients with acute respiratory failure admitted to intensive care units expected to participate in the proposed trial.

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