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

NCT04744298 | Active Not Recruiting

• 1 other identifier: REB20-0646
• Study Type: interventional
• Target: 19,916
• Locations: 1 country
• Sites: 17

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 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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

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

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

  4 months (after the study post-intervention period)

• IMPLEMENTATION (primary fidelity outcome) 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, 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 (step 2) 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 study post-intervention period)

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

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

  4 months (after the study post-intervention period)

Secondary Outcomes (22)

• 28-day and hospital survival

  90 days

• Ventilator duration

  4 months (after the study post-intervention period)

• Driving Pressure

  4 months (after the study post-intervention period)

• Mechanical Power

  4 months (after the study post-intervention period)

• ICU and hospital length of stay

  4 months (after the study post-intervention period)

Study Arms (1)

TheraPPP Pathway

EXPERIMENTAL

The investigators will perform an effectiveness-implementation hybrid study design (type 1) to evaluate the effectiveness and implementation of the TheraPPP pathway. All mechanically ventilated patients admitted to the ICU will enter the pathway. To evaluate effectiveness the investigators will collect patient data for approximately 29 months. To assess acceptability of the pathway the investigators will conduct a survey and focus groups to clinicians who used the Pathway.

Other: TheraPPP

Interventions

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.

TheraPPP Pathway

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• none

Sponsors & Collaborators

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

Study Sites (17)

Peter Lougheed Centre (PLC)

Calgary, Alberta, T1Y 6J4, Canada

Location

Foothills Hospital Intensive Care Unit

Calgary, Alberta, T2N 2T9, Canada

Location

Foothills Medical Center Cardiovascular ICU

Calgary, Alberta, T2N 2T9, Canada

Location

Rockyview General Hospital

Calgary, Alberta, T2V 1P9, Canada

Location

South Health Campus

Calgary, Alberta, T3M 1M4, Canada

Location

Royal Alexandra Hospital

Edmonton, Alberta, T5H 3V9, Canada

Location

Misericordia Community Hospital

Edmonton, Alberta, T5R 4H5, Canada

Location

Mazankowski Alberta Heart Institute

Edmonton, Alberta, T6G 2B7, Canada

Location

University of Alberta Hospital General Systems ICU

Edmonton, Alberta, T6G 2B7, Canada

Location

University of Alberta Hospital Neurosciences Intensive Care Unit

Edmonton, Alberta, T6G 2B7, Canada

Location

Grey Nuns Community Hospital

Edmonton, Alberta, T6L 5X8, Canada

Location

Northern Lights Regional Health Centre

Fort McMurray, Alberta, T9H 1P2, Canada

Location

Queen Elizabeth II Hospital

Grande Prairie, Alberta, T8V 2E8, Canada

Location

Chinook Regional Hospital

Lethbridge, Alberta, T1J 1W5, Canada

Location

Medicine Hat Regional Hospital

Medicine Hat, Alberta, T1A 4H6, Canada

Location

Red Deer Regional Hospital Centre

Red Deer, Alberta, T4N 4E7, Canada

Location

Sturgeon Community Hospital

St. Albert, Alberta, T8N 6C4, Canada

Location

Related Publications (2)

• Krewulak KD, Knight G, Irwin A, Morrissey J, Stelfox HT, Bagshaw SM, Zuege D, Roze des Ordons A, Fiest K, Parhar KKS. Acceptability of the Venting Wisely pathway for use in critically ill adults with hypoxaemic respiratory failure and acute respiratory distress syndrome (ARDS): a qualitative study protocol. BMJ Open. 2024 May 28;14(5):e075086. doi: 10.1136/bmjopen-2023-075086.

  PMID: 38806421 DERIVED

• Parhar KKS, Soo A, Knight G, Fiest K, Niven DJ, Rubenfeld G, Scales D, Stelfox HT, Zuege DJ, Bagshaw S. Protocol and statistical analysis plan for the identification and treatment of hypoxemic respiratory failure and acute respiratory distress syndrome with protection, paralysis, and proning: A type-1 hybrid stepped-wedge cluster randomised effectiveness-implementation study. Crit Care Resusc. 2023 Dec 13;25(4):207-215. doi: 10.1016/j.ccrj.2023.10.008. eCollection 2023 Dec.

  PMID: 38234326 DERIVED

MeSH Terms

Conditions

Respiratory Distress Syndrome; Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Officials

• Ken K 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 Affiliation: University of Calgary

Model Details: The study uses an effectiveness-implementation hybrid design (type 1). Phase 1 will evaluate effectiveness and Phase 2 will assess the implementation of the pathway. Implementation will occur via a pragmatic registry-based stepped wedge cluster randomization of ICUs. The unit of randomization will be a cluster of 2 ICUs. The intervention will be implemented into 1 cluster every 2 months. Once implemented, the cluster will continue to receive it for the remainder of the study. Effectiveness: There will be a 10-month baseline data collection period at the beginning of the study. The total study duration will be 29 months (Estimated18816 mechanically ventilated patients including 2688 in the ARDS subgroup). The comparison (control) therapy will be usual management assessed in the baseline period. Implementation: A process evaluation of pathway implementation will be conducted to 1) quantitatively evaluate fidelity, 2) qualitatively assess acceptability (Estimate 1100 clinicians).

Study Record Dates

• First Submitted: February 1, 2021
• First Posted: February 8, 2021
• Study Start: April 1, 2021
• Primary Completion: March 20, 2024
• Study Completion: October 1, 2025
• Last Updated: June 25, 2024

Record last verified: 2024-06

Locations

CA (17)