The MODE trial was a pragmatic, cluster-randomized, crossover pilot trial conducted in a medical ICU evaluating whether the choice of initial ventilator mode affects outcomes for critically ill adults receiving invasive mechanical ventilation. Patients were assigned by month to receive volume control, pressure control, or adaptive pressure control during continuous mandatory ventilation, and the primary outcome was ventilator-free days through 28 days. Among 566 patients, ventilator-free days were similar across groups (median 23, 22, and 24 days, respectively; P = .60). The trial demonstrated feasibility for testing ventilator mode using a pragmatic crossover design and identified differences in intermediate ventilation metrics that support evaluation in a larger trial.

MODE Trial (Ventilator Mode and Ventilator-Free Days)

When critically ill patients need a breathing machine, clinicians must choose a mode of mechanical ventilation. The three most common modes used for mandatory ventilation are volume control, pressure control, and adaptive pressure control, but it is uncertain whether the initial choice of ventilator mode affects outcomes. The MODE trial compared these commonly used ventilator modes in routine ICU care to evaluate whether mode selection influences duration of mechanical ventilation and patient outcomes.

Importance

Mechanical ventilation is a life-sustaining therapy in critical illness, but it can also contribute to lung injury and other complications. Before the MODE Trial, it was unknown whether the choice of ventilator mode during mandatory ventilation affects clinical outcomes for critically ill adults.

Objective

To determine the effects of volume control, pressure control, and adaptive pressure control ventilation modes on ventilator-free days through 28 days among critically ill adults receiving invasive mechanical ventilation.

Interventions

In a pragmatic, cluster-randomized, crossover pilot trial conducted in a medical ICU between November 1, 2022, and July 31, 2023, patients were assigned by month to receive volume control, pressure control, or adaptive pressure control during continuous mandatory ventilation. The primary outcome was ventilator-free days through 28 days.

Results

Among 566 patients included in the primary analysis, adherence to the assigned mode during the first 72 hours was high (median proportion of assessments in the assigned mode 100% in each group). The median number of ventilator-free days was 23 days in the volume control group, 22 days in the pressure control group, and 24 days in the adaptive pressure control group (P = .60). Intermediate ventilation patterns differed across groups, including the percentage of breaths with tidal volume >8 mL/kg predicted body weight, which was higher with pressure control than with volume control or adaptive pressure control.

Conclusions and Relevance

In this pragmatic pilot trial, ventilator-free days were similar among patients assigned to volume control, pressure control, or adaptive pressure control. The trial demonstrated feasibility of a cluster-randomized crossover design for ventilator mode and identified differences in intermediate ventilation measures that support evaluation in a larger trial.  

Seitz KP, Lloyd BD, Wang L, Shotwell MS, Qian ET, Muhs AL, Richardson RK, Rooks JC, Hennings-Williams V, Sandoval CE, Richardson WD, Morgan TL, Thompson AN, Hastings PG, Ring TP, Stollings JL, Talbot EM, Krasinski DJ, DeCoursey BR, Marvi TK, DeMasi SC, Gibbs KW, Self WH, Mixon AS, Rice TW, Semler MW, Casey JD; Pragmatic Critical Care Research Group. Effect of Ventilator Mode on Ventilator-Free Days in Critically Ill Adults: A Randomized Clinical Trial. Chest. 2025 Oct;168(4):912-923. doi: 10.1016/j.chest.2025.03.024. Epub 2025 Apr 4. PMID: 40189043