Mode of Ventilation During Critical Illness at Multiple Centers (MODEM)

Vanderbilt University Medical Center

Status: Begins enrollment in a year or more

Conditions: Respiratory Failure; Critical Illness; Mechanical Ventilation

Treatments: Other: Adaptive pressure control; Other: Volume control; Other: Pressure control

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07313956

K23HL175246 (U.S. NIH Grant/Contract)

250596

Details and patient eligibility

About

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?

Full description

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.

Enrollment: 4,785 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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
• Patient is receiving extracorporeal membrane oxygenation at the time when inclusion criteria are first met

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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4,785 participants in 3 patient groups

Adaptive Pressure Control Group

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

Pressure Control Group

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

Volume Control Group

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