Mode Of Ventilation During Critical IllnEss Pilot Trial
NCT05563779 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 566
Last updated 2026-02-23
Summary
Landmark trials in critical care have demonstrated that, among critically ill adults receiving invasive mechanical ventilation, the use of low tidal volumes and low airway pressures prevents lung injury and improves patient outcomes. Limited evidence, however, informs the best method of mechanical ventilation to achieve these targets. To provide mechanical ventilation, clinicians must choose between modes of ventilation that directly control tidal volumes ("volume control"), modes that directly control the inspiratory airway pressure ("pressure control"), and modes that are hybrids ("adaptive pressure control"). Whether the choice of the mode used to target low tidal volumes and low inspiratory plateau pressures affects clinical outcomes for critically ill adults receiving mechanical ventilation is unknown. All three modes of mechanical ventilation are commonly used in clinical practice. A large, multicenter randomized trial comparing available modes of mechanical ventilation is needed to understand the effect of each mode on clinical outcomes. The investigators propose a 9-month cluster-randomized cluster-crossover pilot trial evaluating the feasibility of comparing three modes (volume control, pressure control, and adaptive pressure control) for mechanically ventilated ICU patients with regard to the outcome of days alive and free of invasive mechanical ventilation.
Conditions
Interventions
- OTHER
-
Volume Control mode
Volume Control mode for mechanical ventilation
- OTHER
-
Pressure Control mode
Pressure Control mode for mechanical ventilation
- OTHER
-
Adaptive Pressure Control mode
Adaptive Pressure Control mode for mechanical ventilation
Sponsors & Collaborators
-
Vanderbilt University Medical Center
lead OTHER
Principal Investigators
-
Kevin P. Seitz, MD, MSc · Clinical Fellow
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-11-01
- Primary Completion
- 2023-08-28
- Completion
- 2023-08-28
Countries
- United States
Study Locations
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