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

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 2021

Detailed 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 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.

Interventions

  • Other: TheraPPP Pathway
    • 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.

Arms, Groups and Cohorts

  • Experimental: TheraPPP Pathway
    • 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.

Clinical Trial Outcome Measures

Primary Measures

  • 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).
  • 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
  • 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 Measures

  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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)
  • 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
  • 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
  • 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.
  • Total cost for the ICU admission
    • Time Frame: 4 months (after the post-implementation period)
    • Total cost for the ICU admission
  • Total cost for the index hospitalization
    • Time Frame: 4 months (after the post-implementation period)
    • Total cost for the index hospitalization
  • 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
  • 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)

Participating in This Clinical Trial

Inclusion Criteria

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

Exclusion Criteria

  • none

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Calgary
  • Collaborator
    • Alberta Health Services
  • Provider of Information About this Clinical Study
    • Principal Investigator: Ken Kuljit Parhar, MD, Consultant Intensivist & Clinical Assistant Professor – University of Calgary
  • Overall Official(s)
    • Ken Parhar, MD MSc, Principal Investigator, University of Calgary
  • Overall Contact(s)
    • Ken Parhar, MD MSc, 403-944-0735, ken.parhar@ahs.ca

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.