Respiratory Failure
Conditions
Brief summary
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.
Interventions
OTHERVolume Control mode
Volume Control mode for mechanical ventilation
Pressure Control mode for mechanical ventilation
OTHERAdaptive Pressure Control mode
Adaptive Pressure Control mode for mechanical ventilation
Sponsors
Vanderbilt University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
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.
Intervention model description
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).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ventilator-free Days (VFDs) to Day 28 After Enrollment | Enrollment to 28 days | Number of days alive and free from invasive mechanical ventilation between the final liberation from invasive mechanical ventilation before 28 days and study day 28. Patients who continue to receive invasive mechanical ventilation at day 28 or have died prior to day 28 will receive zero VFDs. For patients who return to invasive mechanical ventilation and are subsequently liberated from invasive mechanical ventilation prior to day 28, VFDs will be counted from final liberation from mechanical ventilation. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORKevin P. Seitz, MD, MSc
Clinical Fellow
Participant flow
Recruitment details
During the 9 months of enrollment in the MODE trial, the entire medical ICU will be assigned to a single ventilator mode with the assigned mode alternating between volume control, pressure control, and adaptive pressure control modes every month in a randomly generated sequence. All patients who receive invasive mechanical ventilation and meet inclusion criteria without meeting exclusion criteria will be enrolled. The study mode will be assigned according to the month of enrollment.
Pre-assignment details
Patients will be assigned to only the mode of ventilation at enrollment and analyzed according to the assigned mode. If patients continue to receive mechanical ventilation at the start of the next study block, choice of the ventilator mode will be at the discretion of clinicians. Patients will not crossover to another mode of ventilation. Participation ends at the first of hospital discharge or death.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 57.7 Years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 7 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 176 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 5 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 5 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 94 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 35 Participants |
| Race (NIH/OMB) White | 138 Participants |
| Sex: Female, Male Female | 82 Participants |
| Sex: Female, Male Male | 99 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 59 / 181 | 67 / 198 | 60 / 187 |
| other Total, other adverse events | 0 / 181 | 0 / 198 | 0 / 187 |
| serious Total, serious adverse events | 0 / 181 | 0 / 198 | 0 / 187 |
Outcome results
None listed