Identification and Treatment of Hypoxemic Respiratory Failure and ARDS With Protection, Paralysis, and Proning Pathway

Last updated: June 21, 2024
Sponsor: University of Calgary
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Acute Respiratory Distress Syndrome (Ards)

Cataplexy

Lung Injury

Treatment

TheraPPP

Clinical Study ID

NCT04744298
REB20-0646
  • Ages > 18
  • All Genders

Study Summary

Treatment of patients with Hypoxemic respiratory failure (HRF) and Acute Respiratory Distress Syndrome (ARDS) is complex. Therapies that have been shown to save the lives of patients with HRF and ARDS are available but they are not always provided. To reduce practice variation and improve adherence to evidence-informed therapies, the investigators developed the Treatment of Hypoxemic Respiratory Failure and ARDS with Protection, Paralysis, and Proning (TheraPPP) Pathway.

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Admitted to the one of the 17 adult Intensive Care Units in Alberta

  • Invasively mechanically ventilated

Exclusion

Exclusion Criteria:

  • none

Study Design

Total Participants: 19916
Treatment Group(s): 1
Primary Treatment: TheraPPP
Phase:
Study Start date:
April 01, 2021
Estimated Completion Date:
October 31, 2025

Study Description

Hypoxemic respiratory failure (HRF) and ARDS are common conditions among patients admitted to the Intensive care unit (ICU). Treatment of these patients is complex. Evidence based therapies that can improve survival exist; however, implementation is extremely inconsistent. As a potential solution to this problem, the investigators developed the Treatment of Hypoxemic Respiratory Failure (HRF) and ARDS with Protection, Paralysis, and Proning (TheraPPP) Pathway to reduce practice variation and improve adherence to evidence-informed therapy.

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.

Connect with a study center

  • Foothills Hospital Intensive Care Unit

    Calgary, Alberta T2N 2T9
    Canada

    Site Not Available

  • Foothills Medical Center Cardiovascular ICU

    Calgary, Alberta T2N 2T9
    Canada

    Site Not Available

  • Peter Lougheed Centre (PLC)

    Calgary, Alberta T1Y 6J4
    Canada

    Site Not Available

  • Rockyview General Hospital

    Calgary, Alberta T2V 1P9
    Canada

    Site Not Available

  • South Health Campus

    Calgary, Alberta T3M 1M4
    Canada

    Site Not Available

  • Grey Nuns Community Hospital

    Edmonton, Alberta T6L 5X8
    Canada

    Site Not Available

  • Mazankowski Alberta Heart Institute

    Edmonton, Alberta T6G 2B7
    Canada

    Site Not Available

  • Misericordia Community Hospital

    Edmonton, Alberta T5R 4H5
    Canada

    Site Not Available

  • Royal Alexandra Hospital

    Edmonton, Alberta T5H 3V9
    Canada

    Site Not Available

  • University of Alberta Hospital General Systems ICU

    Edmonton, Alberta T6G 2B7
    Canada

    Site Not Available

  • University of Alberta Hospital Neurosciences Intensive Care Unit

    Edmonton, Alberta T6G 2B7
    Canada

    Site Not Available

  • Northern Lights Regional Health Centre

    Fort McMurray, Alberta T9H 1P2
    Canada

    Site Not Available

  • Queen Elizabeth II Hospital

    Grande Prairie, Alberta T8V 2E8
    Canada

    Site Not Available

  • Chinook Regional Hospital

    Lethbridge, Alberta T1J 1W5
    Canada

    Site Not Available

  • Medicine Hat Regional Hospital

    Medicine Hat, Alberta T1A 4H6
    Canada

    Site Not Available

  • Red Deer Regional Hospital Centre

    Red Deer, Alberta T4N 4E7
    Canada

    Site Not Available

  • Sturgeon Community Hospital

    St. Albert, Alberta T8N 6C4
    Canada

    Site Not Available

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