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NCT Number: NCT04744298

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Acute Respiratory Distress Syndrome ARDS, Human Hypoxemic Respiratory Failure Lung Diseases Respiration Disorders Respiratory Distress Syndrome Respiratory Insufficiency Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Foothills Hospital Intensive Care Unit, Calgary, Alberta, Canada

Loading trial locations.

About this study

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:

  • Effectiveness of the pathway. A cost-effectiveness analysis is a secondary objective.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • none

Treatment and study plan

TheraPPP

Other

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.

Primary outcomes

  1. EFFECTIVENESS (primary clinical outcome) 28-day ventilator free days

    Time frame: 4 months (after the study post-intervention period)

    A composite outcome of survival and days spent not ventilated over the first 28 days

  2. IMPLEMENTATION (primary fidelity outcome) Composite Fidelity Score

    Time frame: 4 months (after the study post-intervention period)

    The composite fidelity score is measured daily for each patient. It is scored out of 5 and awards 1 point for each fidelity indicator (listed below) that investigators are able to measure:

    • If ventilated, is a height measured (step 1)
    • If arterial to inspired oxygen ratio (PaO2:FiO2 ratio or PF ratio) ≤300, is the medial tidal volume ≤8mL/kg (step 2)
    • If PF ratio ≤300, is a plateau pressure measured (step 3)
    • IF patient has HRF and PF ratio ≤150, was neuromuscular blockade used in that 24 hour period (step 4)
    • If the patient has HRF and PF ratio ≤150 and FiO2 ≥0.6, did the patient receive prone ventilation (step 5)

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

    Time frame: 4 months (after the study post-intervention period)

    Cost per ventilator free day saved from the perspective of the health care system over the index hospitalization period

Secondary outcomes

  1. 28-day and hospital survival

    Time frame: 90 days

    Number of patients who die in the ICU, hospital, and at or before 28-day hospital censored at 90 days

  2. Ventilator duration

    Time frame: 4 months (after the study post-intervention period)

    The number of ventilated days. If a patient is invasively mechanically ventilated via endotracheal tube or tracheostomy for any period of time in a 24 hour period (0000-2359) this is considered a ventilated day. A ventilated day is the component of VFDs that reflects duration of ventilation.

  3. Driving Pressure

    Time frame: 4 months (after the study post-intervention period)

    Calculated on patients ventilated with PF ratio (partial pressures of oxygen (paO2) / fraction of inspired oxygen (FiO2) ≤ 300 on a controlled mode as plateau pressure - positive end expiratory pressure (PEEP).

  4. Mechanical Power

    Time frame: 4 months (after the study post-intervention period)

    Calculated on patients ventilated with PF ratio ≤ 300 on a controlled mode using the formula Power = 0.098*respiratory rate•(tidal volume/1000)*(Peak Pressure - (0.5 • Driving Pressure)).

  5. ICU and hospital length of stay

    Time frame: 4 months (after the study post-intervention period)

    The number of days that patients stay in the ICU and in hospital

  6. Proportion of patients receiving rescue therapies specifically Extracorporeal Life Support (ECLS)

    Time frame: 4 months (after the study post-intervention period)

    The proportion of patients receiving rescue therapies including ECLS

  7. The proportion of patients ventilated with a height measured

    Time frame: 4 months (after the study post-intervention period)

    Total number of ventilated patients for with a height measured divided by the total number of patients ventilated

  8. Proportion of patient days with PF ratio ≤300 with a tidal volume ≤8mL/kg

    Time frame: 4 months (after the study post-intervention period)

    The total number of patient days with arterial to inspired oxygen ratio(PaO2:FiO2 ratio or PF ratio) ≤300 with a tidal volume ≤8 mL/kg divided by the total number of of patient days with arterial to inspired oxygen ratio (PaO2:FiO2 ratio or PF ratio) ≤300

  9. Proportion of patient days with PF ratio ≤300 with a plateau pressure measured

    Time frame: 4 months (after the study post-intervention period)

    The total number of patient days with PF ratio ≤300 with a plateau pressure measured divided by the total number of patient days with PF ratio ≤300

  10. Proportion of patient days with HRF and PF ratio ≤150 who receive neuromuscular blockade

    Time frame: 4 months (after the study post-intervention period)

    The number of patient days with HRF and PF ratio ≤150 who receive neuromuscular blockade divided by the number of patient days with HRF and PF ratio ≤150

  11. Proportion of patient days with HRF and PF ratio ≤150 and FiO2 ≥0.6 receiving prone ventilation

    Time frame: 4 months (after the study post-intervention period)

    The number of patient days with HRF and PF ratio ≤150 and FiO2 ≥0.6 receiving prone ventilation divided by the number of patient days with HRF and PF ratio ≤150 and FiO2 ≥0.6

  12. Theoretical Framework of Acceptability - Composite Acceptability Score

    Time frame: 4 months (after the study post-intervention period)

    Pathway acceptability is measured using the Theoretical Framework of Acceptability (TFA). The primary outcome for acceptability is a composite score of the proportion of seven TFA constructs [(1) affective attitude (2) burden (3) ethicality (4) intervention coherence (5) opportunity costs (6) perceived effectiveness (7) self-efficacy] graded with a median score of 4 or above from a 5-point Likert scale, in which 1 indicates strong disagreement (and lower acceptability) and 5 indicates strong agreement (and higher acceptability).

  13. Theoretical Framework of Acceptability - Opportunity costs construct

    Time frame: 4 months (after the study post-intervention period)

    Benefits or costs to the participant for using the pathway graded on a 5-point Likert scale in which 1 indicates strong disagreement (and lower acceptability) and 5 indicates strong agreement (and higher acceptability), Median (IQR)

  14. Theoretical Framework of Acceptability - Perceived effectiveness construct

    Time frame: 4 months (after the study post-intervention period)

    The extent to which the intervention is perceived as likely to achieve its purpose graded graded on a 5-point Likert scale in which 1 indicates strong disagreement (and lower acceptability) and 5 indicates strong agreement (and higher acceptability), Median (IQR)

  15. Theoretical Framework of Acceptability - Affective attitude construct

    Time frame: 4 months (after the study post-intervention period)

    How an individual feels about the intervention graded on a 5-point Likert scale in which 1 indicates strong disagreement (and lower acceptability) and 5 indicates strong agreement (and higher acceptability), Median (IQR)

  16. Theoretical Framework of Acceptability - Burden construct

    Time frame: 4 months (after the study post-intervention period)

    The perceived amount of effort that is required to participate in the intervention graded on a 5-point Likert scale in which 1 indicates strong disagreement (and lower acceptability) and 5 indicates strong agreement (and higher acceptability), Median (IQR)

  17. Theoretical Framework of Acceptability - Ethicality construct

    Time frame: 4 months (after the study post-intervention period)

    The extent to which the intervention has a good fit with an individual's value graded on a 5-point Likert scale in which 1 indicates strong disagreement (and lower acceptability) and 5 indicates strong agreement (and higher acceptability), Median (IQR)

  18. Theoretical Framework of Acceptability - Self efficacy construct

    Time frame: 4 months (after the study post-intervention period)

    The participant's confidence that they can perform the behavior(s) required to participate in the intervention graded on a 5-point Likert scale in which 1 indicates strong disagreement (and lower acceptability) and 5 indicates strong agreement (and higher acceptability), Median (IQR)

  19. Theoretical Framework of Acceptability - Intervention coherence construct

    Time frame: 4 months (after the study post-intervention period)

    The extent to which the participant understands the invention and how it works graded on a 5-point Likert scale in which 1 indicates strong disagreement (and lower acceptability) and indicates strong agreement (and higher acceptability), Median (IQR)

  20. Total cost: ICU admission

    Time frame: 4 months (after the study post-intervention period)

    Total cost for the ICU admission

  21. Total cost: Index hospitalization

    Time frame: 4 months (after the study post-intervention period)

    Total cost for the index hospitalization

  22. Cost per quality adjusted life year (QALY)

    Time frame: 4 months (after the study post-intervention period)

    Cost per quality adjusted life year (QALY) from the health care system perspective over the patient's lifetime

Sponsors and collaborators

Lead sponsor

University of Calgary

Other

Collaborators

  • Alberta Health services

Registry information

Official study title

Identification and Treatment of Hypoxemic Respiratory Failure (HRF) and ARDS With Protection, Paralysis, and Proning: TheraPPP Study

Important dates

Study start
2021
Primary completion
2024
Study completion
2026
First posted
Feb 8, 2021
Registry last updated
May 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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