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Proportional Assist Ventilation for Minimizing the Duration of Mechanical Ventilation: The PROMIZING Study

Not Applicable
Completed
Conditions
Critically Ill
Acute Respiratory Failure
Interventions
Other: PSV ventilation strategy
Other: PAV+ ventilation strategy
Registration Number
NCT02447692
Lead Sponsor
Lawson Health Research Institute
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
575
Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
PSV ventilation strategyPSV ventilation strategyThe control is the standard of care PSV ventilation strategy, designed to adjust the level of support according to usual clinical parameters.
PAV+ ventilation strategyPAV+ ventilation strategyThe intervention is a PAV+ ventilation strategy, designed to adjust the level of support (gain) to target a predefined range of respiratory muscle pressure.
Primary Outcome Measures
NameTimeMethod
Time from randomization to successful liberation from invasive mechanical ventilation.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 Outcome Measures
NameTimeMethod
Weaning Progressup to 90 days

Measured as time from randomization to: first SBT; first successful SBT; first extubation

Serious Adverse Events90 days

Incidence of reported serious adverse events

Time from randomization to live ICU discharge (up to day 90)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.

Ventilator-free days at 14, 21 and 28 days post randomization14, 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 hospital discharge (up to day 90)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.

Weaning Difficulties90 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 Complications90 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)

Mortalityup to 90 days

Measured as time to death, ICU mortality; hospital mortality; 21, 28, and 90 day mortality

Tolerance of modes90 days

Measured as number of patients ever requiring A/C mode post randomization; number of patient-days requiring A/C mode post randomization

Trial Locations

Locations (22)

Kingston General Hospital

🇨🇦

Kingston, Ontario, Canada

Victoria Hospital

🇨🇦

London, Ontario, Canada

Sunnybrook Hospital - Health Sciences Centre

🇨🇦

Toronto, Ontario, Canada

UHN- Toronto General Hospital

🇨🇦

Toronto, Ontario, Canada

Hôpital Universitaire Pitié-Salpêtrière

🇫🇷

Paris, France

El Centro de Educación Médica e Investigaciones Clínicas "Norberto Quirno"

🇦🇷

Buenos Aires, Argentina

London Health Sciences Centre - University Hospital

🇨🇦

London, Ontario, Canada

North York General Hospital

🇨🇦

Toronto, Ontario, Canada

St. Michael's Hospital

🇨🇦

Toronto, Ontario, Canada

UHN- Toronto Western Hospital

🇨🇦

Toronto, Ontario, Canada

Centre hospitalier de l'Université de Montréal (CHUM)

🇨🇦

Montréal, Quebec, Canada

Royal Victoria Hospital

🇨🇦

Montréal, Quebec, Canada

Institut Universitaire de cardiologie et de pneumologie de Quebec

🇨🇦

Québec, Quebec, Canada

Centre Hospitalier Universitaire (CHU) de Angers

🇫🇷

Angers, France

Centre Hospitalier Intercommunal de Créteil

🇫🇷

Créteil, France

Hôpital Henri Mondor (Assistance Publique-Hôpitaux de Paris)

🇫🇷

Créteil, France

University Hospital of Ferrara

🇮🇹

Ferrara, Italy

Centre Hospitalier Universitaire (CHU) de Rouen

🇫🇷

Rouen, France

University Hospital of Heraklion

🇬🇷

Heraklion, Greece

Hospital de Sant Pau

🇪🇸

Barcelona, Spain

San Giovanni Battista University Hospital

🇮🇹

Turin, Italy

King Abdulaziz Medical City

🇸🇦

Riyadh, Saudi Arabia

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