MODE: Mode Of Ventilation During Critical IllnEss Pilot Trial
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Volume Control mode During invasive mechanical ventilation in a study location, Volume Control will be used as the mode for continuous mandatory ventilation. |
Other: Volume Control mode
Volume Control mode for mechanical ventilation
|
| Active Comparator: Pressure Control mode During invasive mechanical ventilation in a study location, Pressure Control will be used as the mode for continuous mandatory ventilation. |
Other: Pressure Control mode
Pressure Control mode for mechanical ventilation
|
| Active Comparator: Adaptive Pressure Control mode During invasive mechanical ventilation in a study location, Adaptive Pressure Control will be used as the mode for continuous mandatory ventilation. |
Other: Adaptive Pressure Control mode
Adaptive Pressure Control mode for mechanical ventilation
|
Outcome Measures
Primary Outcome Measures
- 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.
Other Outcome Measures
- Exposure to assigned study mode in first 3 days (Feasibility Outcome) [Enrollment to 72 hours]
Proportion of time receiving invasive mechanical ventilation in the study ICU during the first 72 hours after enrollment in which the patient was receiving the assigned mode of ventilation
- Adherence to study mode in first 3 days (Feasibility Outcome) [Enrollment to 72 hours]
Proportion of time receiving invasive mechanical ventilation in the study ICU during the first 72 hours after enrollment in which the patient was receiving the assigned mode of ventilation, excluding spontaneous breathing trials
- Time from enrollment to initiation of assigned mode of mechanical ventilation (Feasibility Outcome) [Enrollment to 28 days]
- Number of patients with a "Mode Modification Sheet" completed by treating clinicians (Feasibility Outcome) [Enrollment to 28 days]
- Median daily exhaled tidal volume on each study day (Exploratory Efficacy and Safety Outcome) [Enrollment to 7 days]
- Exhaled tidal volumes above target range (Exploratory Efficacy and Safety Outcome) [Enrollment to 7 days]
Proportion of recorded breaths with exhaled tidal volume values above target range (>8mL/kg PBW) on each study day
- Hypoxemia during mechanical ventilation (Exploratory Safety and Efficacy Outcome) [Enrollment to 28 days]
Episodes of hypoxemia while receiving invasive mechanical ventilation: SpO2 <85% for more than 5 minutes
- Severe acidemia during mechanical ventilation (Exploratory Safety and Efficacy Outcome) [Enrollment to 28 days]
Episodes of severe acidemia during mechanical ventilation: pH < 7.1 on blood gas
- Number of blood gas laboratory tests per day while receiving mechanical ventilation (Exploratory Safety and Efficacy Outcome) [Enrollment to 28 days]
- Pneumomediastinum or pneumothorax during course of mechanical ventilation (Exploratory Efficacy and Safety Outcome) [Enrollment to 28 days]
- SOFA score daily on the first 7 study days (Exploratory Safety and Efficacy Outcome) [Enrollment to 7 days]
- Delirium and coma free days to day 28 (Exploratory Efficacy and Safety Outcome) [Enrollment to 28 days]
Number of days alive and without delirium or coma before 28 days to study day 28
- Intensive care unit-free days to study day 28 (Exploratory Clinical Outcome) [Enrollment to 28 days]
Number of days alive and free from intensive care unit admission after the final transfer out of the intensive care unit before 28 days to study day 28
- Hospital-Free days to study day 28 (Exploratory Clinical Outcome) [Enrollment to 28 days]
Number of days alive and free from hospitalization after the final transfer out of the hospital before 28 days to study day 28
- In-hospital mortality to study day 28 (Exploratory Clinical Outcome) [Enrollment to 28 days]
All-cause mortality prior to discharge from the hospital, assessed at 28 days after enrollment
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Vanderbilt University Medical Center | Nashville | Tennessee | United States | 37232 |
Sponsors and Collaborators
- Vanderbilt University Medical Center
Investigators
- Principal Investigator: Kevin P. Seitz, MD, MSc, Clinical Fellow
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 220446