Mode Of Ventilation During Critical IllnEss Pilot Trial (MODE)

Vanderbilt University Medical Center

Status: Completed

Conditions: Respiratory Failure

Treatments: Other: Adaptive Pressure Control mode; Other: Volume Control mode; Other: Pressure Control mode

Study type: Interventional

Funder types: Other

Identifiers

NCT05563779

220446

Details and patient eligibility

About

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.

Enrollment: 566 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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566 participants in 3 patient groups

Volume Control mode

Active Comparator group

Description:

During invasive mechanical ventilation in a study location, Volume Control will be used as the mode for continuous mandatory ventilation.

Treatment:

Other: Volume Control mode

Pressure Control mode

Active Comparator group

Description:

During invasive mechanical ventilation in a study location, Pressure Control will be used as the mode for continuous mandatory ventilation.

Treatment:

Other: Pressure Control mode

Adaptive Pressure Control mode

Active Comparator group

Description:

During invasive mechanical ventilation in a study location, Adaptive Pressure Control will be used as the mode for continuous mandatory ventilation.

Treatment:

Other: Adaptive Pressure Control mode