Proportional Assist Ventilation for Minimizing the Duration of Mechanical Ventilation: The PROMIZING Study
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Critically Ill
- Sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Enrollment
- 575
- Locations
- 22
- Primary Endpoint
- Time from randomization to successful liberation from invasive mechanical ventilation.
- Status
- Completed
- Last Updated
- 11 months ago
Overview
Brief Summary
For adult patients with acute respiratory failure requiring invasive mechanical ventilation, does a ventilation strategy using proportional assist ventilation with load-adjustable gain factors (PAV+) result in a shorter duration of time spent on mechanical ventilation than a ventilation strategy using pressure support ventilation (PSV)?
Detailed Description
Patients with acute respiratory failure require mechanical ventilation to help them breathe until they recover from their acute illness. Although mechanical ventilation is necessary to sustain life in such situations, it can induce weakness of the respiratory muscles which may lead to prolonged dependence on the ventilator. Prolonged dependence on mechanical ventilation is associated with increased mortality, morbidity and costs to the healthcare system. Thus, a main goal of assisted mechanical ventilation is to reduce the patient's respiratory distress while maintaining some respiratory muscle activity. To attain this goal, the amount of ventilator assistance should theoretically be adjusted to target normal or reasonable levels of respiratory effort. Modes of Mechanical Ventilation: Proportional assist ventilation with load-adjustable gain factors (PAV+) is a mode of mechanical ventilation which delivers assistance to breathe in proportion to the patient's effort. The proportional assistance, called the gain, can be adjusted by the clinician to maintain the patient's respiratory effort or workload within a reasonable range. This is the only mode of ventilation which allows for measurement and targeting of a specific range of respiratory muscle activity by the patient. Pressure support ventilation (PSV) is a mode of ventilation which is considered the current standard of care for assisting breathing of patients during the recovery phase of acute respiratory failure. Several studies have shown short term advantages of PAV over PSV, including improved patient-ventilator synchronization, improved adaptability to changes in patient effort, and improved sleep quality. Goal of this Randomized Controlled Trial: To demonstrate that for patients with acute respiratory failure, ventilation with PAV+, being more physiological, will result in a shorter duration of time spent on mechanical ventilation than ventilation with PSV.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Time from randomization to successful liberation from invasive mechanical ventilation.
Time Frame: up to 90 days
"Successful liberation" is defined as removal of the endotracheal tube AND remaining alive with no need for reintubation/reinstitution of invasive mechanical ventilation for 7 days post extubation, or until successful ICU discharge, or until live hospital discharge, whichever comes first.
Secondary Outcomes
- Weaning Progress(up to 90 days)
- Serious Adverse Events(90 days)
- Time from randomization to live ICU discharge (up to day 90)(up to 90 days)
- Ventilator-free days at 14, 21 and 28 days post randomization(14, 21 and 28 days post randomization)
- Time from randomization to live hospital discharge (up to day 90)(up to 90 days)
- Weaning Difficulties(90 days)
- Weaning Complications(90 days)
- Tolerance of modes(90 days)
- Mortality(up to 90 days)