Critical Illness, Mechanical Ventilation, Respiratory Failure
Conditions
Brief 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.
Interventions
OTHERVolume control
Volume control mode for invasive mechanical ventilation
OTHERPressure control
Pressure control mode for invasive mechanical ventilation
OTHERAdaptive pressure control
Adaptive pressure control for invasive mechanical ventilation
Sponsors
Vanderbilt University Medical Center
National Heart, Lung, and Blood Institute (NHLBI)
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Masking description
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.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ventilator-free days in the first 28 days | From enrollment to 28 days after enrollment | The number of calendar days between enrollment and 28 days after enrollment, on which the patient is alive and free of invasive mechanical ventilation. Receipt of invasive mechanical ventilation will be considered to end when patients undergo the final tracheal extubation or disconnection of the ventilator from a tracheostomy tube between enrollment and day 28. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| All-cause, 28-day, in-hospital mortality | From enrollment to 28 days after enrollment | All-cause, 28-day, in-hospital mortality, defined as death from any cause occurring between enrollment and 28 days after enrollment with outcome ascertainment ending at hospital discharge. |
Countries
United States
Outcome results
None listed