Acute Respiratory Distress SyndromeTheraPPPNCT04070053
Treatment of Hypoxemic Respiratory Failure and ARDS With Protection, Paralysis, and Proning (TheraPPP) Pathway
A study testing TheraPPP Pathway in people with Acute Respiratory Distress Syndrome and Hypoxemic Respiratory Failure, run by University of Calgary at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Distress Syndrome, Hypoxemic Respiratory Failure, ARDS, Human
- What is being tested?
- TheraPPP Pathway
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 920 participants
- Where
- 1 siteCanada
- Study dates
- 23 Aug 2019to 30 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Foothills Medical Center Intensive Care Unit (Pod A)
- Invasively mechanically ventilated
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment of Hypoxemic Respiratory Failure and ARDS With Protection, Paralysis, and Proning (TheraPPP) Pathway: a Pilot Before and After Study
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.
Read the 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.
- Being tested
- TheraPPP Pathway
- Medical subject headings
- Respiratory Distress Syndrome, Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TheraPPP PathwayOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: TheraPPP Pathway |
What is being measured
The primary outcome is the main question the study is designed to answer.
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,
- 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).
Measured: 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
Measured: 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.
Measured: 4 months (after the post-implementation period)
Secondary outcomes (18)
The proportion of ventilated patients with a height measured
Total number of ventilated patients with a height measured divided by the total number of ventilated patients
Measured: 4 months (after the post-implementation period)
The proportion of ventilated patients with a height measured within 1 hour of admission
Total number of ventilated patients with a height measured within 1 hour of admission divided by the total number of ventilated patients
Measured: 4 months (after the post-implementation period)
The proportion of patients ventilated ≥24 hours with a height measured
Total number of ventilated patients for ≥24 hours with a height measured divided by the total number of ventilated patients ≥24 hours
Measured: 4 months (after the post-implementation period)
The median time to height measurement from admission
The median time to height measurement from admission for patients ventilated ≥24 hours
Measured: 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
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
Measured: 4 months (after the post-implementation period)
The 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
Measured: 4 months (after the post-implementation period)
The 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
Measured: 4 months (after the post-implementation period)
The proportion of patient days with HRF and PF ratio ≤100 who receive neuromuscular blockade
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
Measured: 4 months (after the post-implementation period)
The 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
Measured: 4 months (after the post-implementation period)
The proportion of patient days with HRF and PF ratio ≤100 and FiO2 ≥0.6 receiving prone ventilation
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
Measured: 4 months (after the post-implementation period)
Days of safe ventilation for females
Days of safe ventilation for females (proportion of days of safe ventilation with a median daily tidal volume ≤ 8 mL/kg predicted body weight)
Measured: 4 months (after the post-implementation period)
Number of patients who do not survive
Number of patients who die in the ICU, hospital, and at or before 28-day hospital
Measured: 4 months (after the post-implementation period)
Number of ventilator-free days (VFDs) 28-day ventilator-free days (VFDs)
Number of days that patients are not on the ventilator
Measured: 4 months (after the post-implementation period)
The proportion of patients receiving rescue therapies
The proportion of patients receiving rescue therapies including inhaled vasodilators, Extracorporeal Life Support.
Measured: 4 months (after the post-implementation period)
Total cost for the ICU admission
Total cost for the ICU admission
Measured: 4 months (after the post-implementation period)
Total cost for the index hospitalization
Total cost for the index hospitalization
Measured: 4 months (after the post-implementation period)
Length of Stay (LOS) (ICU, hospital) / the number of days that patients stay in the ICU and in hospital
The number of days that patients stay in the ICU and in hospital
Measured: 4 months (after the post-implementation period)
Days of safe ventilation
Days of safe ventilation (proportion of days of safe ventilation with a median daily tidal volume ≤ 8 mL/kg predicted body weight)
Measured: 4 months (after the post-implementation period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start23 Aug 2019
- Primary completion16 Mar 2021
- Study completion30 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory Distress SyndromeStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 920 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Collaborators
- Alberta Health services
- Responsible party
- Principal investigator, Ken Kuljit Parhar, MD, University of Calgary
- Investigators
- Ken Parhar, MD MSc, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04070053
- Sponsor's protocol ID
- REB19-0939
- Other IDs
- 897, 2019
- Acronym
- TheraPPP
- Status last verified
- Jun 2023
- First submitted
- 22 Aug 2019
- Last updated
- 18 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Hypoxemic Respiratory Failure and ARDS With Protection, Paralysis, and Proning (TheraPPP) Pathway: a Pilot Before and After Study
- ClinicalTrials.gov ID
- NCT04070053
- Acronym / sponsor ID
- TheraPPP / REB19-0939
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 920 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Collaborators
- Alberta Health services
- Study start
- 23 Aug 2019 (actual)
- Primary completion
- 16 Mar 2021 (actual)
- Study completion
- 30 Mar 2022 (actual)
- First posted
- 28 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| TheraPPP Pathway | Experimental | Other: TheraPPP PathwayWe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Foothills Medical Center Intensive Care Unit (Pod A)
- Invasively mechanically ventilated
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TheraPPP PathwayTheraPPP 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. | Other | TheraPPP Pathway |
Primary outcome
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, 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).
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.
18 secondary outcomes
The proportion of ventilated patients with a height measured
Time frame: 4 months (after the post-implementation period)
The proportion of ventilated patients with a height measured within 1 hour of admission
Time frame: 4 months (after the post-implementation period)
The proportion of patients ventilated ≥24 hours with a height measured
Time frame: 4 months (after the post-implementation period)
The median time to height measurement from admission
Time frame: 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
Time frame: 4 months (after the post-implementation period)
The proportion of patient days with PF ratio ≤300 with a plateau pressure measured
Time frame: 4 months (after the post-implementation period)
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 proportion of patient days with HRF and PF ratio ≤100 who receive neuromuscular blockade
Time frame: 4 months (after the post-implementation period)
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 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)
Days of safe ventilation for females
Time frame: 4 months (after the post-implementation period)
Number of patients who do not survive
Time frame: 4 months (after the post-implementation period)
Number of ventilator-free days (VFDs) 28-day ventilator-free days (VFDs)
Time frame: 4 months (after the post-implementation period)
The proportion of patients receiving rescue therapies
Time frame: 4 months (after the post-implementation period)
Total cost for the ICU admission
Time frame: 4 months (after the post-implementation period)
Total cost for the index hospitalization
Time frame: 4 months (after the post-implementation period)
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)
Days of safe ventilation
Time frame: 4 months (after the post-implementation period)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ken Parhar, MD MSc principal investigator
University of Calgary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TheraPPP Pathway in people with Acute Respiratory Distress Syndrome and Hypoxemic Respiratory Failure, run by University of Calgary at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FEASIBILITY (Fidelity) Fidelity of the intervention using a composite fidelity score (time frame: 4 months (after the post-implementation period)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2023.