Proportional Assist Ventilation for Minimizing the Duration of Mechanical Ventilation: The PROMIZING Study (PROMIZING)
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|ClinicalTrials.gov Identifier: NCT02447692|
Recruitment Status : Recruiting
First Posted : May 19, 2015
Last Update Posted : March 31, 2022
|Condition or disease||Intervention/treatment||Phase|
|Critically Ill Acute Respiratory Failure||Other: PSV ventilation strategy Other: PAV+ ventilation strategy||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||558 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Proportional Assist Ventilation for Minimizing the Duration of Mechanical Ventilation: The PROMIZING Study|
|Actual Study Start Date :||September 14, 2016|
|Estimated Primary Completion Date :||December 2022|
|Estimated Study Completion Date :||December 2022|
Active Comparator: PSV ventilation strategy
The control is the standard of care PSV ventilation strategy, designed to adjust the level of support according to usual clinical parameters.
Other: PSV ventilation strategy
An algorithm for adjusting the level of pressure support according to usual clinical parameters; patients not tolerating PSV will be switched to Assist/Control mode according to predefined criteria
Active Comparator: PAV+ ventilation strategy
The intervention is a PAV+ ventilation strategy, designed to adjust the level of support (gain) to target a predefined range of respiratory muscle pressure.
Other: PAV+ ventilation strategy
An algorithm for adjusting the level of support (gain) to maintain a predefined range of respiratory muscle pressure; patients not tolerating PAV+ (Puritan Bennett™ 840 or 980 ventilator) will be switched to Assist/Control mode according to predefined criteria
- 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.
- Ventilator-free days at 14, 21 and 28 days post randomization [ Time Frame: 14, 21 and 28 days post randomization ]"Ventilator-free days" (VFDs) are defined as the number of days alive and free of INVASIVE ventilation post SUCCESSFUL EXTUBATION or post successful termination of invasive mechanical ventilation (MV) from time of randomization to day 21 post randomization. "Successful extubation" 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.
- Time from randomization to live ICU discharge (up to day 90) [ Time Frame: up to 90 days ]Patients will remain in the study and will continue on the assigned ventilation strategy until: successful extubation, successful ICU discharge, live hospital discharge, death, or 90 days post randomization, whichever comes first.
- Time from randomization to live hospital discharge (up to day 90) [ Time Frame: up to 90 days ]Patients will remain in the study and will continue on the assigned ventilation strategy until: successful extubation, successful ICU discharge, live hospital discharge, death, or 90 days post randomization, whichever comes first.
- Mortality [ Time Frame: up to 90 days ]Measured as ICU mortality; hospital mortality; 14, 21, 28, and 90 day mortality
- Weaning Progress [ Time Frame: up to 90 days ]Measured as time from randomization to: first SBT; first successful SBT; first extubation
- Weaning Difficulties [ Time Frame: 90 days ]Measured as the number of patients failing first SBT or first extubation attempt and requiring up to 7 days to extubate (difficult weaning group/group 2); failing first SBT or first extubation attempt and requiring more than 7 days to extubate (prolonged weaning group/group 3)
- Weaning Complications [ Time Frame: 90 days ]Measured as the number of patients: requiring non-invasive ventilation post-extubation; ventilated more than 7 days post randomization, ventilated more than 21 days from time of intubation (prolonged MV group); receiving tracheostomy post-randomization, requiring re-intubation (up to 7d after planned extubation)
- Tolerance of modes [ Time Frame: 90 days ]Measured as number of patients ever requiring A/C mode post randomization; number of patient-days requiring A/C mode post randomization
- Cumulative dose of narcotics (converted to morphine equivalents); benzodiazepines (converted to midazolam equivalents); propofol, and dexmedetomidine [ Time Frame: 90 days ]These are measures of sedation
- Number of patients and number of patient-days receiving any antipsychotic medication [ Time Frame: 28 days ]This is a surrogate measure of delirium
- Subgroup analyses based on: (a) duration of MV prior to randomization greater than 5 days [ Time Frame: 90 days ]Identifies a subgroup of patients at time of randomization who are at risk for prolonged weaning
- Subgroup analyses based on (b) failing an SBT prior to randomization [ Time Frame: 90 days ]Identifies a subgroup of patients at time of randomization classified as difficult weaning vs. failed CPAP 0 trial vs. failed weaning criteria prior to randomization
- Subgroup analyses based on (c) failed extubation prior to randomization [ Time Frame: 90 days ]Identifies a subgroup of patients at time of randomization classified as having "difficult weaning".
- Subgroup analyses based on (d) mild vs. moderate vs. severe frailty [ Time Frame: 90 days ]Differentiates between severely frail and less frail
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02447692
|Contact: Sorcha Mulligan||416-360-4000 ext 77049||Sorcha.Mulligan@unityhealth.to|
|Contact: Karen J Bosma||519-663-3531||KarenJ.Bosma@lhsc.on.ca|
|Principal Investigator:||Karen J Bosma||London Health Sciences Centre, London, Ontario, Canada|
|Principal Investigator:||Laurent Brochard||St. Michael's Hospital, Toronto, Ontario, Canada|