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

NCT04070053 | Completed

• 3 other identifiers: REB19-09398972019
• Study Type: interventional
• Target: 920
• Locations: 1 country
• Sites: 1

Brief 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 (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.

Conditions

Acute Respiratory Distress Syndrome; Hypoxemic Respiratory Failure; ARDS, Human

Outcome Measures

Primary Outcomes (3)

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

  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, 1. If ventilated ≥24 hours, is a height measured (step 1) 2. 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) 3. If PF ratio ≤300, is a plateau pressure measured (step 3) 4. IF patient has HRF and PF ratio ≤150, was neuromuscular blockade used in that 24 hour period (step 4) 5. If the patient has HRF and PF ratio ≤150 and FiO2 ≥0.6, did the patient receive prone ventilation (step 5).

  4 months (after the post-implementation period)

• FEASIBILITY (Economic) Cost per safe ventilation day

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

  4 months (after the post-implementation period)

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

  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.

  4 months (after the post-implementation period)

Secondary Outcomes (18)

• The proportion of ventilated patients with a height measured

  4 months (after the post-implementation period)

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

  4 months (after the post-implementation period)

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

  4 months (after the post-implementation period)

• The median time to height measurement from admission

  4 months (after the post-implementation period)

• 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

  4 months (after the post-implementation period)

Study Arms (1)

TheraPPP Pathway

EXPERIMENTAL

We will perform a before and after study to evaluate the feasibility and acceptability of the HRF and ARDS Pathway during its pilot implementation. All mechanically ventilated patients will enter the pathway during the one month implementation and one year post-implementation periods. To assess Pathway feasibility we will collect patient data for approximately two years and one month: one year immediately prior to implementation, one month during, and one year following implementation. To assess acceptability of the pathway we will conduct a survey to clinicians who used the Pathway.

Other: TheraPPP Pathway

Interventions

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.

TheraPPP Pathway

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• none

Sponsors & Collaborators

• University of Calgary: lead
• Alberta Health services: collaborator

Study Sites (1)

Foothills Hospital Intensive Care Unit

Calgary, Alberta, T2N 2T9, Canada

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome; Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Officials

• Ken Parhar, MD MSc

  University of Calgary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Intensivist & Clinical Assistant Professor

Model Details: We will perform a before and after study to evaluate the feasibility and acceptability of the HRF and ARDS Pathway during its pilot implementation. All mechanically ventilated patients will enter the pathway during the one month implementation period and one year post-implementation period. To assess Pathway feasibility we will collect patient data for two years and one month: one year immediately prior to implementation as well as one month during plus one year following implementation. To assess acceptability of the pathway we will conduct a survey to clinicians who used the pathway.

Study Record Dates

• First Submitted: August 22, 2019
• First Posted: August 28, 2019
• Study Start: August 23, 2019
• Primary Completion: March 16, 2021
• Study Completion: March 30, 2022
• Last Updated: June 18, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)