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N/A N=566 Randomized Single-blind Treatment

Mode Of Ventilation During Critical IllnEss Pilot Trial

Respiratory Failure

Enrolled (actual)
566
Serious AEs
0.0%
Results posted
Feb 2026
Primary outcome: Primary: Ventilator-free Days (VFDs) to Day 28 After Enrollment — 23; 22; 24 Ventilator-free days to day 28

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Volume Control mode (Other); Pressure Control mode (Other); Adaptive Pressure Control mode (Other)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Vanderbilt University Medical Center
Primary completion
Aug 2023

Outcome Measures

OutcomeResultp-value
PRIMARY
Ventilator-free Days (VFDs) to Day 28 After Enrollment
23; 22; 24

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.

Eligibility Criteria

Inclusion Criteria

  • Age ≥ 18 years
  • Receiving mechanical ventilation through an endotracheal tube or tracheostomy
  • Admitted to the study ICU

Exclusion Criteria

  • Patient is pregnant
  • Patient is a prisoner
  • Patient receiving invasive mechanical ventilation at place of residence prior to hospital admission
  • Patient receiving extracorporeal membrane oxygenation at the time of admission to the study ICU
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05563779). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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