Mode of Ventilation During Critical Illness at Multiple Centers

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

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

4785 participants

Study Classification

INTERVENTIONAL

Study Start Date

2027-07-31

Study Completion Date

2030-03-31

Brief Summary

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The goal of this clinical trial is to learn whether the choice of ventilator mode for patients on breathing machines in the intensive care unit affects their survival and recovery. To do this, researchers will assign the entire participating intensive care unit to one of the three available ventilator modes, alternating which mode is assigned in random sequence every 2 months. The main question it aims to answer is: Does the choice between volume control, pressure control, and adaptive pressure control affect the number of days that patients are alive and free of the breathing machine?

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Detailed Description

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The MODEM trial is a cluster-randomized, cluster-crossover clinical trial comparing the effectiveness of three ventilator modes (volume control vs pressure control vs adaptive pressure control) for mechanical ventilation of critically ill adults at multiple centers. A total of 4,785 critically ill adults receiving invasive mechanical ventilation in intensive care units will be enrolled and included in the primary analysis. Each study unit will be assigned to a ventilator mode and will switch between modes every 2 months in an order determined by randomization. Enrolled patients will be assigned to receive volume control, pressure control, or adaptive pressure control according to the mode assigned to the unit at the time they were enrolled. The primary outcome will be ventilator-free days in the first 28 days, and the secondary outcome will be all-cause, 28-day in-hospital mortality.

Conditions

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Respiratory Failure Mechanical Ventilation Critical Illness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

In the MODEM trial, the entire study ICU will be assigned to a single ventilator mode (cluster-randomized) and the ICU will switch between volume control, pressure control, and adaptive pressure control modes every two months in a randomly generated sequence (cluster-crossover). Enrolled patients will be assigned to only one group at the time of their enrollment.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

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

Study Groups

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Adaptive Pressure Control Group

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

Intervention Type OTHER

Adaptive pressure control for invasive mechanical ventilation

Pressure Control Group

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

Intervention Type OTHER

Pressure control mode for invasive mechanical ventilation

Volume Control Group

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

Intervention Type OTHER

Volume control mode for invasive mechanical ventilation

Interventions

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Volume control

Volume control mode for invasive mechanical ventilation

Intervention Type OTHER

Pressure control

Pressure control mode for invasive mechanical ventilation

Intervention Type OTHER

Adaptive pressure control

Adaptive pressure control for invasive mechanical ventilation

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patient is receiving mechanical ventilation through an endotracheal tube or tracheostomy
* Patient is physically located in a participating adult ICU

Exclusion Criteria

* Patient is known to be less than 18 years old
* Patient is known to be a prisoner
* Patient is known to have been receiving invasive mechanical ventilation at place of residence prior to hospital admission

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No