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NCT Number: NCT04070053

Treatment of Hypoxemic Respiratory Failure and ARDS With Protection, Paralysis, and Proning (TheraPPP) 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 (HRF) and ARDS with Protection, Paralysis, and Proning (TheraPPP) Pathway.

The purpose of this pilot study is to test the feasibility and acceptability of the TheraPPP Pathway. To assess feasibility, the investigators will test the ability to measure adherence to the pathway as well as patient and economic outcomes. To assess perceptions about the acceptability of the TheraPPP Pathway, the investigators will conduct a survey to clinicians who used the Pathway.

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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, T2N 2T9, Canada

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 objective of this pilot before and after study is to evaluate the feasibility and acceptability of the TheraPPP Pathway.

The pilot study will use a before and after quasi-experimental design to evaluate the feasibility and acceptability of the TheraPPP pathway. The TheraPPP pathway is a comprehensive evidence-based, stakeholder-informed pathway for the diagnosis and management of HRF. The study will be conducted in a single center mixed medical surgical ICU. The study population will include all patients who are admitted to the ICU and are mechanically ventilated.

The pathway will be implemented over a one month period, followed by a one year post implementation assessment period. The comparison (control) therapy will be usual management assessed in the one year pre-implementation period. We estimate approximately 1000 patients will be included in the study.

The primary objectives of the pilot study will be to assess feasibility and acceptability. To assess feasibility, the investigators will test the ability to measure: (1) Fidelity through 5 process of care indicators (2) Patient and economic outcomes. To assess the acceptability of the Pathway, the investigators will conduct a survey to clinicians who used the pathway. The acceptability survey will be sent to approximately 250 ICU clinicians.

For data analysis, no specific comparisons will be made as the investigators are testing the ability to measure the outcomes. However, feasibility and acceptability data will be presented in aggregate as frequency with proportion or median with interquartile range, as appropriate.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Foothills Medical Center Intensive Care Unit (Pod A)
  • Invasively mechanically ventilated

Exclusion criteria

  • none

Treatment and study plan

TheraPPP Pathway

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. FEASIBILITY (Fidelity) Fidelity of the intervention using a composite fidelity score

    Time frame: 4 months (after the post-implementation 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 ≥24 hours, 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 stratified by volume and pressure control (step2/3)
    • 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).

  2. FEASIBILITY (Economic) Cost per safe ventilation day

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

    Cost per safe ventilation day from the perspective of the health care system

  3. ACCEPTABILITY Pathway Acceptability measured using the Theoretical Framework of Acceptability (TFA)

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

    The primary outcome for acceptability is the proportion of seven TFA constructs (7 constructs of acceptability) graded with a median score of 5 or above from a 7-point Likert scale, indicating agreement.

Secondary outcomes

  1. The proportion of ventilated patients with a height measured

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

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

  2. The proportion of ventilated patients with a height measured within 1 hour of admission

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

    Total number of ventilated patients with a height measured within 1 hour of admission divided by the total number of ventilated patients

  3. The proportion of patients ventilated ≥24 hours with a height measured

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

    Total number of ventilated patients for ≥24 hours with a height measured divided by the total number of ventilated patients ≥24 hours

  4. The median time to height measurement from admission

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

    The median time to height measurement from admission for patients ventilated ≥24 hours

  5. The proportion of patient days with arterial to inspired oxygen ratio(PaO2:FiO2 ratio or PF ratio) ≤300 with a tidal volume ≤8mL/kg stratified by volume and pressure control

    Time frame: 4 months (after the post-implementation 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 stratified by volume and pressure control

  6. The proportion of patient days with PF ratio ≤300 with a plateau pressure measured

    Time frame: 4 months (after the post-implementation 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

  7. The proportion of patient days with HRF and PF ratio ≤150 who receive neuromuscular blockade

    Time frame: 4 months (after the post-implementation 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

  8. The proportion of patient days with HRF and PF ratio ≤100 who receive neuromuscular blockade

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

    The number of patient days with HRF and PF ratio ≤100 who receive neuromuscular blockade divided by the number of patient days with HRF and PF ratio ≤100

  9. The proportion of patient days with HRF and PF ratio ≤150 and FiO2 ≥0.6 receiving prone ventilation

    Time frame: 4 months (after the post-implementation 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

  10. The proportion of patient days with HRF and PF ratio ≤100 and FiO2 ≥0.6 receiving prone ventilation

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

    The number of patient days with HRF and PF ratio ≤100 and FiO2 ≥0.6 receiving prone ventilation divided by the number of patient days with HRF and PF ratio ≤100 and FiO2 ≥0.6

  11. Days of safe ventilation for females

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

    Days of safe ventilation for females (proportion of days of safe ventilation with a median daily tidal volume ≤ 8 mL/kg predicted body weight)

  12. Number of patients who do not survive

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

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

  13. Number of ventilator-free days (VFDs) 28-day ventilator-free days (VFDs)

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

    Number of days that patients are not on the ventilator

  14. The proportion of patients receiving rescue therapies

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

    The proportion of patients receiving rescue therapies including inhaled vasodilators, Extracorporeal Life Support.

  15. Total cost for the ICU admission

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

    Total cost for the ICU admission

  16. Total cost for the index hospitalization

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

    Total cost for the index hospitalization

  17. Length of Stay (LOS) (ICU, hospital) / the number of days that patients stay in the ICU and in hospital

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

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

  18. Days of safe ventilation

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

    Days of safe ventilation (proportion of days of safe ventilation with a median daily tidal volume ≤ 8 mL/kg predicted body weight)

Sponsors and collaborators

Lead sponsor

University of Calgary

Other

Collaborators

  • Alberta Health services

Registry information

Official study title

Treatment of Hypoxemic Respiratory Failure and ARDS With Protection, Paralysis, and Proning (TheraPPP) Pathway: a Pilot Before and After Study

Acronym: TheraPPP

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
Aug 28, 2019
Registry last updated
Jun 18, 2023

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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