NCT07313956

Mode of Ventilation During Critical Illness at Multiple Centers

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 4,785 (estimated)
• Sponsor: Vanderbilt University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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?

Detailed 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.

Conditions

• Respiratory Failure
• Mechanical Ventilation
• Critical Illness

Interventions

Type	Name	Description
OTHER	Volume control	Volume control mode for invasive mechanical ventilation
OTHER	Pressure control	Pressure control mode for invasive mechanical ventilation
OTHER	Adaptive pressure control	Adaptive pressure control for invasive mechanical ventilation

Timeline

• Start date: 2027-07-01
• Primary completion: 2030-01-01
• Completion: 2030-03-01
• First posted: 2026-01-02
• Last updated: 2026-01-02

Locations

1 site across 1 country: United States