PAV+ ventilation strategy for Acute Respiratory Failure

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Acute Respiratory Failure+1 MorePSV ventilation strategy - Other
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

This trial found that for patients requiring mechanical ventilation, PAV+ resulted in a shorter duration of time spent on mechanical ventilation than PSV.

Eligible Conditions
  • Acute Respiratory Failure
  • Critically Ill Patients

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 21 Secondary · Reporting Duration: 14, 21 and 28 days post randomization

Day 28
Ventilator-free days at 14 and 28 days post randomization
Day 28
Ventilator-free days at 14, 21 and 28 days post randomization
28 days
Cumulative doses of narcotics
Number of patients and number of patient-days receiving any antipsychotic medication
Number of patients receiving any antipsychotic medication
90 days
Cumulative dose of narcotics (converted to morphine equivalents); benzodiazepines (converted to midazolam equivalents); propofol, and dexmedetomidine
Difficult Weaning
Sensitivity analyses of primary and assigning a value of 0 ventilator-free days to any participant who dies at any time during the study period
Tracheal Extubation
Subgroup analyses based on (b) failing an SBT prior to randomization
Subgroup analyses based on (c) failed extubation prior to randomization
Subgroup analyses based on (d) mild vs. moderate vs. severe frailty
Subgroup analyses based on: (a) duration of MV prior to randomization greater than 5 days
Tolerance of Modes
Tolerance of modes
Weaning Complications
Weaning Difficulties
Day 21
Ventilator Free Days (VFDs) at 21 days post randomization
up to 90 days
Mortality
Mortality measured as ICU mortality, hospital mortality, 14, 21, 28 and 90 day mortality
Time from randomization to live ICU discharge
Time from randomization to live ICU discharge (up to day 90)
Time from randomization to live hospital discharge
Time from randomization to live hospital discharge (up to day 90)
Time from randomization to successful liberation
Time from randomization to successful liberation from invasive mechanical ventilation.
Weaning Progress

Trial Safety

Trial Design

2 Treatment Groups

PAV+ ventilation strategy
1 of 2
PSV ventilation strategy
1 of 2

Active Control

558 Total Participants · 2 Treatment Groups

Primary Treatment: PAV+ ventilation strategy · No Placebo Group · N/A

PAV+ ventilation strategy
Other
ActiveComparator Group · 1 Intervention: PAV+ ventilation strategy · Intervention Types: Other
PSV ventilation strategy
Other
ActiveComparator Group · 1 Intervention: PSV ventilation strategy · Intervention Types: Other

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 14, 21 and 28 days post randomization

Who is running the clinical trial?

MedtronicIndustry Sponsor
574 Previous Clinical Trials
732,333 Total Patients Enrolled
Canadian Critical Care Trials GroupOTHER
28 Previous Clinical Trials
223,414 Total Patients Enrolled
Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,232 Previous Clinical Trials
24,675,094 Total Patients Enrolled
Lawson Health Research InstituteLead Sponsor
613 Previous Clinical Trials
401,563 Total Patients Enrolled
Laurent BrochardPrincipal InvestigatorSt. Michael's Hospital, Toronto, Ontario, Canada
Karen J BosmaPrincipal InvestigatorLondon Health Sciences Centre, London, Ontario, Canada

Eligibility Criteria

Age 18+ · All Participants · 1 Total Inclusion Criteria

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