Identification and Treatment of Hypoxemic Respiratory Failure and ARDS With Protection, Paralysis, and Proning Pathway
NCT ID: NCT04744298
Last Updated: 2024-06-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
NA
19916 participants
INTERVENTIONAL
2021-04-01
2025-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The overall objective of TheraPPP Pathway is to improve the quality of care for patients with HRF. Implementation of the pathway across Alberta will test the effectiveness and implementation of the TheraPPP Pathway.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Treatment of Hypoxemic Respiratory Failure and ARDS With Protection, Paralysis, and Proning (TheraPPP) Pathway
NCT04070053
Severe ARDS: Generating Evidence
NCT03021824
High Flow Therapy for the Treatment of Respiratory Failure in the ED
NCT02236559
Physiologic Effects of Continuous Positive Airway Pressure and High Flow Nasal Oxygenation in Patients with Acute Respiratory Distress Syndrome.
NCT06694311
Veno-venous Extracorporeal CO2 Removal in ARDS-patients to Treat Respiratory Acidosis
NCT01911533
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The TheraPPP pathway is a comprehensive evidence-based, stakeholder-informed pathway for the diagnosis and management of HRF. The overall objective of the pathway is to improve the quality of care for patients with HRF. The specific objectives are to evaluate:
1. Effectiveness of the pathway. A cost-effectiveness analysis is a secondary objective.
2. Implementation of the pathway by conducting a process evaluation which will assess fidelity of the delivered interventions and clinician perceptions about the acceptability of the pathway.
Mechanically ventilated patients admitted to any one of 17 adult ICUs in Alberta will receive the intervention. One ICU (Calgary) is the setting for a pilot study (NCT04070053).
For data analysis, the investigators will use chart abstraction to quantitatively assess the fidelity of the delivered intervention, and surveys and focus groups to qualitatively assess clinician perceptions about the acceptability of the pathway. Fidelity of the intervention will be tracked using process of care indicators that reflect the five key steps of the pathway.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
Effectiveness: There will be a 10-month baseline data collection period at the beginning of the study. The total study duration will be 29 months (Estimated18816 mechanically ventilated patients including 2688 in the ARDS subgroup). The comparison (control) therapy will be usual management assessed in the baseline period.
Implementation: A process evaluation of pathway implementation will be conducted to 1) quantitatively evaluate fidelity, 2) qualitatively assess acceptability (Estimate 1100 clinicians).
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
TheraPPP Pathway
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.
TheraPPP
TheraPPP Steps:
Step 1. All mechanically ventilated patients will have a height measured and documented. Step 2. Screening for HRF. Step 3. Initiate Lung Protective Ventilation (LPV). Step 4. Paralysis. Step 5. Prone Positioning.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
TheraPPP
TheraPPP Steps:
Step 1. All mechanically ventilated patients will have a height measured and documented. Step 2. Screening for HRF. Step 3. Initiate Lung Protective Ventilation (LPV). Step 4. Paralysis. Step 5. Prone Positioning.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Invasively mechanically ventilated
Exclusion Criteria
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Alberta Health services
OTHER
University of Calgary
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Ken Kuljit Parhar, MD
Consultant Intensivist & Clinical Assistant Professor Affiliation: University of Calgary
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Ken K Parhar, MD, MSc
Role: PRINCIPAL_INVESTIGATOR
University of Calgary
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Peter Lougheed Centre (PLC)
Calgary, Alberta, Canada
Foothills Hospital Intensive Care Unit
Calgary, Alberta, Canada
Foothills Medical Center Cardiovascular ICU
Calgary, Alberta, Canada
Rockyview General Hospital
Calgary, Alberta, Canada
South Health Campus
Calgary, Alberta, Canada
Royal Alexandra Hospital
Edmonton, Alberta, Canada
Misericordia Community Hospital
Edmonton, Alberta, Canada
Mazankowski Alberta Heart Institute
Edmonton, Alberta, Canada
University of Alberta Hospital General Systems ICU
Edmonton, Alberta, Canada
University of Alberta Hospital Neurosciences Intensive Care Unit
Edmonton, Alberta, Canada
Grey Nuns Community Hospital
Edmonton, Alberta, Canada
Northern Lights Regional Health Centre
Fort McMurray, Alberta, Canada
Queen Elizabeth II Hospital
Grande Prairie, Alberta, Canada
Chinook Regional Hospital
Lethbridge, Alberta, Canada
Medicine Hat Regional Hospital
Medicine Hat, Alberta, Canada
Red Deer Regional Hospital Centre
Red Deer, Alberta, Canada
Sturgeon Community Hospital
St. Albert, Alberta, Canada
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Krewulak KD, Knight G, Irwin A, Morrissey J, Stelfox HT, Bagshaw SM, Zuege D, Roze des Ordons A, Fiest K, Parhar KKS. Acceptability of the Venting Wisely pathway for use in critically ill adults with hypoxaemic respiratory failure and acute respiratory distress syndrome (ARDS): a qualitative study protocol. BMJ Open. 2024 May 28;14(5):e075086. doi: 10.1136/bmjopen-2023-075086.
Parhar KKS, Soo A, Knight G, Fiest K, Niven DJ, Rubenfeld G, Scales D, Stelfox HT, Zuege DJ, Bagshaw S. Protocol and statistical analysis plan for the identification and treatment of hypoxemic respiratory failure and acute respiratory distress syndrome with protection, paralysis, and proning: A type-1 hybrid stepped-wedge cluster randomised effectiveness-implementation study. Crit Care Resusc. 2023 Dec 13;25(4):207-215. doi: 10.1016/j.ccrj.2023.10.008. eCollection 2023 Dec.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
REB20-0646
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.