Study Summary
This trial is testing a new way to treat patients with hypoxemic respiratory failure and ARDS. The hope is that this new way will save lives.
Eligible Conditions
- Hypoxemic Respiratory Failure
- Acute Respiratory Distress Syndrome
- Acute Respiratory Distress Syndrome (ARDS)
Treatment Effectiveness
Study Objectives
5 Primary · 29 Secondary · Reporting Duration: 4 months (after the study post-intervention period)
Month 4
Cost per quality adjusted life year (QALY)
Days of safe ventilation
Driving Pressure
ECONOMIC (primary economic outcome) Cost per ventilator free day saved
Ventilator - respiratory equipment
Ventilator - respiratory equipment
ICU and hospital length of stay
IMPLEMENTATION (primary acceptability outcome) Theoretical Framework of Acceptability - Composite Acceptability Score
IMPLEMENTATION (primary fidelity outcome) Composite Fidelity Score
Mechanical Power
Continuous Positive Airway Pressure
Proportion of patient days with HRF and PF ratio ≤100 who receive neuromuscular blockade
Proportion of patient days with HRF and PF ratio ≤150 and FiO2 ≥0.6 receiving prone ventilation
Proportion of patient days with HRF and PF ratio ≤150 who receive neuromuscular blockade
Proportion of patient days with PF ratio ≤300 with a plateau pressure measured
Proportion of patient days with PF ratio ≤300 with a tidal volume ≤8mL/kg
Proportion of patient days with PF ratio ≤300 with a tidal volume ≤8mL/kg stratified by volume and pressure control
Proportion of patients receiving rescue therapies
Proportion of patients receiving rescue therapies specifically Extracorporeal Life Support (ECLS)
Continuous Positive Airway Pressure
The proportion of patients ventilated with a height measured
The proportion of patients ventilated ≥24 hours with a height measured
Theoretical Framework of Acceptability - Affective attitude construct
Theoretical Framework of Acceptability - Burden construct
Theoretical Framework of Acceptability - Composite Acceptability Score
Theoretical Framework of Acceptability - Ethicality construct
Theoretical Framework of Acceptability - Intervention coherence construct
Theoretical Framework of Acceptability - Opportunity costs construct
Theoretical Framework of Acceptability - Perceived effectiveness construct
Theoretical Framework of Acceptability - Self efficacy construct
Total cost: ICU admission
Total cost: Index hospitalization
Ventilator duration
90 days
28-day and hospital survival
Trial Safety
Trial Design
1 Treatment Group
TheraPPP Pathway
1 of 1
Experimental Treatment
19916 Total Participants · 1 Treatment Group
Primary Treatment: TheraPPP · No Placebo Group · N/A
TheraPPP Pathway
Other
Experimental Group · 1 Intervention: TheraPPP · Intervention Types: OtherTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 4 months (after the study post-intervention period)
Who is running the clinical trial?
University of CalgaryLead Sponsor
717 Previous Clinical Trials
554,329 Total Patients Enrolled
2 Trials studying Hypoxemic Respiratory Failure
1,516 Patients Enrolled for Hypoxemic Respiratory Failure
Alberta Health servicesOTHER
145 Previous Clinical Trials
307,635 Total Patients Enrolled
2 Trials studying Hypoxemic Respiratory Failure
1,516 Patients Enrolled for Hypoxemic Respiratory Failure
Ken K Parhar, MD, MScPrincipal InvestigatorUniversity of Calgary
Eligibility Criteria
Age 18+ · All Participants · 2 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You are currently on a breathing machine.