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Protective Measures + Paralysis + Proning for Acute Respiratory Distress Syndrome

N/A
Recruiting
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

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.

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.Check my eligibility
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.See study design
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 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
ECONOMIC (primary economic outcome) Cost per ventilator free day saved
Ventilator - respiratory equipment
IMPLEMENTATION (primary fidelity outcome) Composite Fidelity Score
Secondary outcome measures
28-day and hospital survival
Cost per quality adjusted life year (QALY)
Driving Pressure
+19 more

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.

Find a Location

Who is running the clinical trial?

Alberta Health servicesOTHER
157 Previous Clinical Trials
629,628 Total Patients Enrolled
University of CalgaryLead Sponsor
791 Previous Clinical Trials
848,818 Total Patients Enrolled
Ken K Parhar, MD, MScPrincipal InvestigatorUniversity of Calgary

Media Library

TheraPPP (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04744298 — N/A
Acute Respiratory Distress Syndrome Research Study Groups: TheraPPP Pathway
Acute Respiratory Distress Syndrome Clinical Trial 2023: TheraPPP Highlights & Side Effects. Trial Name: NCT04744298 — N/A
TheraPPP (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04744298 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Identification and Treatment of Hypoxemic Respiratory Failure and ARDS With Protection, Paralysis, and Proning Pathway
Ken Kuljit Parhar, MD 2021. "Identification and Treatment of Hypoxemic Respiratory Failure and ARDS With Protection, Paralysis, and Proning Pathway". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04744298.
~4979 spots leftby Apr 2025
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