Protective Measures + Paralysis + Proning for Acute Respiratory Distress Syndrome

N/A

Waitlist Available

Led By Ken K Parhar, MD, MSc

Research Sponsored by University of Calgary

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 months (after the study post-intervention period)

Awards & highlights

No Placebo-Only Group

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.

Who is the study for?

This trial is for patients in any of the 17 adult Intensive Care Units in Alberta who are on invasive mechanical ventilation due to severe respiratory issues like ARDS or hypoxemic respiratory failure. There are no specific exclusion criteria, so a wide range of patients with these conditions can participate.

What is being tested?

The TheraPPP Pathway is being tested to see if it improves care for patients with acute respiratory problems. It involves evidence-based treatments including protection (lung-protective ventilation), paralysis (medication-induced), and proning (lying face down) to help breathing.

What are the potential side effects?

Potential side effects may include discomfort from lying face down, muscle weakness from paralysis agents, and possible complications related to lung-protective ventilation strategies.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 months (after the study post-intervention period)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 months (after the study post-intervention period)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 months (after the study post-intervention period) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

ECONOMIC (primary economic outcome) Cost per ventilator free day saved

Ventilator - respiratory equipment

IMPLEMENTATION (primary fidelity outcome) Composite Fidelity Score

Secondary study objectives

28-day and hospital survival

Cost per quality adjusted life year (QALY)

Driving Pressure

+19 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: TheraPPP PathwayExperimental Treatment1 Intervention

The investigators will perform an effectiveness-implementation hybrid study design (type 1) to evaluate the effectiveness and implementation of the TheraPPP pathway. All mechanically ventilated patients admitted to the ICU will enter the pathway. To evaluate effectiveness the investigators will collect patient data for approximately 29 months. To assess acceptability of the pathway the investigators will conduct a survey and focus groups to clinicians who used the Pathway.

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