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

Acute Respiratory Distress Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04744298
• Other study ID #: REB20-0646
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2021
• Est. completion date: February 2024

Study information

• Verified date: November 2023
• Source: University of Calgary
• Contact: Ken K Parhar, MD, MSc
• Phone: 403-944-2471
• Email: ken.parhar[@]albertahealthservices.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 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:

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

2. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 19916
• Est. completion date: February 2024
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

• Invasively mechanically ventilated

Exclusion Criteria:

• none

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• ARDS, Human
• Hypoxemic Respiratory Failure
• Paralysis
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn
• Respiratory Insufficiency

Intervention

Other:
• TheraPPP
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.

Locations

Country	Name	City	State
Canada	Foothills Hospital Intensive Care Unit	Calgary	Alberta
Canada	Foothills Medical Center Cardiovascular ICU	Calgary	Alberta
Canada	Peter Lougheed Centre (PLC)	Calgary	Alberta
Canada	Rockyview General Hospital	Calgary	Alberta
Canada	South Health Campus	Calgary	Alberta
Canada	Grey Nuns Community Hospital	Edmonton	Alberta
Canada	Mazankowski Alberta Heart Institute	Edmonton	Alberta
Canada	Misericordia Community Hospital	Edmonton	Alberta
Canada	Royal Alexandra Hospital	Edmonton	Alberta
Canada	University of Alberta Hospital General Systems ICU	Edmonton	Alberta
Canada	University of Alberta Hospital Neurosciences Intensive Care Unit	Edmonton	Alberta
Canada	Northern Lights Regional Health Centre	Fort McMurray	Alberta
Canada	Queen Elizabeth II Hospital	Grande Prairie	Alberta
Canada	Chinook Regional Hospital	Lethbridge	Alberta
Canada	Medicine Hat Regional Hospital	Medicine Hat	Alberta
Canada	Red Deer Regional Hospital Centre	Red Deer	Alberta
Canada	Sturgeon Community Hospital	St. Albert	Alberta

Sponsors (2)

Lead Sponsor	Collaborator
University of Calgary	Alberta Health services

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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: 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)	4 months (after the study post-intervention period)
Primary	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	28-day and hospital survival	Number of patients who die in the ICU, hospital, and at or before 28-day hospital censored at 90 days	90 days
Secondary	Ventilator duration	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.	4 months (after the study post-intervention period)
Secondary	Driving Pressure	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 months (after the study post-intervention period)
Secondary	Mechanical Power	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)).	4 months (after the study post-intervention period)
Secondary	ICU and hospital length of stay	The number of days that patients stay in the ICU and in hospital	4 months (after the study post-intervention period)
Secondary	Proportion of patients receiving rescue therapies specifically Extracorporeal Life Support (ECLS)	The proportion of patients receiving rescue therapies including ECLS	4 months (after the study post-intervention period)
Secondary	The proportion of patients ventilated with a height measured	Total number of ventilated patients for with a height measured divided by the total number of patients ventilated	4 months (after the study post-intervention period)
Secondary	Proportion of patient days with PF ratio =300 with a tidal volume =8mL/kg	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	4 months (after the study post-intervention period)
Secondary	Proportion of patient days with PF ratio =300 with a plateau pressure measured	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	4 months (after the study post-intervention period)
Secondary	Proportion of patient days with HRF and PF ratio =150 who receive neuromuscular blockade	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	4 months (after the study post-intervention period)
Secondary	Proportion of patient days with HRF and PF ratio =150 and FiO2 =0.6 receiving prone ventilation	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	4 months (after the study post-intervention period)
Secondary	Theoretical Framework of Acceptability - Composite Acceptability Score	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).	4 months (after the study post-intervention period)
Secondary	Theoretical Framework of Acceptability - Opportunity costs construct	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)	4 months (after the study post-intervention period)
Secondary	Theoretical Framework of Acceptability - Perceived effectiveness construct	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)	4 months (after the study post-intervention period)
Secondary	Theoretical Framework of Acceptability - Affective attitude construct	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)	4 months (after the study post-intervention period)
Secondary	Theoretical Framework of Acceptability - Burden construct	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)	4 months (after the study post-intervention period)
Secondary	Theoretical Framework of Acceptability - Ethicality construct	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)	4 months (after the study post-intervention period)
Secondary	Theoretical Framework of Acceptability - Self efficacy construct	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)	4 months (after the study post-intervention period)
Secondary	Theoretical Framework of Acceptability - Intervention coherence construct	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)	4 months (after the study post-intervention period)
Secondary	Total cost: ICU admission	Total cost for the ICU admission	4 months (after the study post-intervention period)
Secondary	Total cost: Index hospitalization	Total cost for the index hospitalization	4 months (after the study post-intervention period)
Secondary	Cost per quality adjusted life year (QALY)	Cost per quality adjusted life year (QALY) from the health care system perspective over the patient's lifetime	4 months (after the study post-intervention period)