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

  • STATUS
    Recruiting
  • End date
    Dec 19, 2022
  • participants needed
    558
  • sponsor
    Lawson Health Research Institute
Updated on 19 April 2022
mechanical ventilation
pressure support

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)?

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.

Details
Condition Critically Ill, Acute Respiratory Failure
Treatment PSV ventilation strategy, PAV+ ventilation strategy
Clinical Study IdentifierNCT02447692
SponsorLawson Health Research Institute
Last Modified on19 April 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

C1. Patient/SDM has provided consent OR Plan to obtain deferred consent as Patient
incapable and no SDM available to provide consent within the randomization window
E1. Upon review of Criteria A, B, and C, the patient still passes and the patient has
passed the PST
E2. Does not meet Weaning Criteria OR Fails the ZERO CPAP Trial OR Fails the SBT

Exclusion Criteria

B9. Patient has met enrolment inclusion criteria B1-B5 AND has tolerated pressure
support of 0-20 cm H2O or proportional assist ventilation of 0-85% ≥24 consecutive
hours (including time on CPAP, t-piece, or tracheostomy mask). Note (1): It is
acceptable to include a patient who has been tried on pressure support or proportional
assist ventilation but has required pressures >20 cmH2O or assistance >85% or has
required return to A/C ventilation within the 24 hour time window; Note (2): B9 does
not apply to patients while on ECMO
C4. Patient/SDM has declined consent
C5. Patient incapable and no SDM available to provide consent (not applicable if plan
to obtain deferred consent)
E3. Passed SBT on t-piece, FiO2 0.40 for 30-120 minutes
E4. Approval withdrawn (by physician or patient/SDM)
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