Mode Of Ventilation During Critical IllnEss Pilot Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

566 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-01

Study Completion Date

2023-08-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Respiratory Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

In the MODE trial, the entire study ICU will be assigned to a single mode for continuous mandatory ventilation and the ICU will switch between volume control, pressure control, and adaptive pressure control every month in a randomly generated sequence (cluster-crossover).

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Observer bias will be minimized by use of objective endpoints collected in duplicate by \[1\] study personnel blinded to group assignment and \[2\] automated data extraction from the electronic health record.

Study Groups

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Volume Control mode

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

Group Type ACTIVE_COMPARATOR

Volume Control mode

Intervention Type OTHER

Volume Control mode for mechanical ventilation

Pressure Control mode

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

Group Type ACTIVE_COMPARATOR

Pressure Control mode

Intervention Type OTHER

Pressure Control mode for mechanical ventilation

Adaptive Pressure Control mode

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

Group Type ACTIVE_COMPARATOR

Adaptive Pressure Control mode

Intervention Type OTHER

Adaptive Pressure Control mode for mechanical ventilation

Interventions

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Volume Control mode

Volume Control mode for mechanical ventilation

Intervention Type OTHER

Pressure Control mode

Pressure Control mode for mechanical ventilation

Intervention Type OTHER

Adaptive Pressure Control mode

Adaptive Pressure Control mode for mechanical ventilation

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No