Identification and Treatment of Hypoxemic Respiratory Failure (HRF) and ARDS With Protection, Paralysis, and Proning: TheraPPP Study
Phase: NA
Conditions: Acute Respiratory Distress Syndrome, Hypoxemic Respiratory Failure, ARDS, Human
Sponsor: University of Calgary

Authors
Ken Kuljit S. Parhar MD, BScH, MSc, FRCPC
Program
University of Calgary Department of Critical Care
Institutions
University of Calgary, Alberta Health Services, University of Alberta 
Title 
Identification and Treatment of Hypoxemic Respiratory Failure 
(HRF) and ARDS with Protection, Paralysis, and Proning: 
TheraPPP Study
Principal Investigator 
Corresponding author 
Medical expert:
Ken Parhar MD, BScH, MSc FRCPC. 
Consultant Intensivist & Clinical Associate Professor
Department of Critical Care Medicine
McCaig Tower, Foothills Hospital
3134 Hospital Drive NW
Calgary, AB T2N 2T9 
Phone (403) 943-5488
ken.parhar@albertahealthservices.ca
Investigator(s) and sub-
investigators responsible 
for the study
Dr Dan Niven, Dr Tom Stelfox, Dr Kirsten Fiest, Dr Chip Doig, Dr Dan Zuege, 
Dr Sean Bagshaw, Dr Fiona Clement, Dr Andrea Soo
Protocol/version #:
Current Version Date: 
REB Application #: 
2.5
February 14, 2023 
20-0646
Previous IRB Approved Version Dates:
October 28, 2022 (2.4)
September 2, 2022 (2.3)
June 13, 2022 (v 2.2)
February 23, 2022 (v 2.1)
December 9, 2020 (v 2.0)
April 27, 2020 (v 1.0)
Protocol and SAP revision history 
Protocol 
SAP
Version & Date
Summary of Change
Version 
Action 
1.0 04/27/2020
First version
N/A
SAP not finalized
2.0 12/09/2020
Access to data in new Clinical Information System 
N/A
SAP not finalized
2.1 02/23/2022
Updated with the completion of the SAP by the Scientific 
Steering Group:
•
Follow-up period increased from 2 to 4 months
1.0 
SAP finalized 
Feb 22, 2022
2.2 06/13/2022
Incentive added for Focus Group participants
1.0
SAP reviewed, no change
2.3 09/02/2022
Increased total number of Focus Groups
1.0
SAP reviewed, no change
2.4 10/28/2022
Incentive added for survey participation
1.0
SAP reviewed, no change
2.5 02/14/2023
Editorial updates, added summary of amendments table
1.0
SAP reviewed, no change
This protocol has been developed by the Principal Investigator and Co-Investigators and its contents are the intellectual property of 
this group. It is an offence to reproduce or use the information and data in this protocol for any purpose other than this study without 
prior approval from the Principal Investigator.
1
Study Summary

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1 Study Summary
Title
Identification and Treatment of Hypoxemic Respiratory Failure (HRF) and ARDS 
with Protection, Paralysis, and Proning: TheraPPP Study
Short Title
TheraPPP Study
Protocol Number
REB20-0646
Methodology
Effectiveness-implementation hybrid study design (type 1). Clinical effectiveness 
and implementation of an HRF and ARDS standardized care pathway will be 
assessed. Implementation will occur via a pragmatic registry-based stepped wedge 
cluster randomization of Intensive Care Units (ICUs).
Study Duration
There will be a 10-month baseline data collection period at the beginning of the 
study. The total study duration will be 29 months.
Study Center(s)
Patients admitted to any one of 17 adult Intensive Care Units (ICUs) in Alberta will 
receive the intervention. 
Objectives
The overall objective is to improve the quality of care for patients with HRF. The 
specific objectives are to evaluate:
(1) Clinical Effectiveness of the pathway using a pragmatic registry-based cluster
randomized stepped-wedge implementation study involving 17 ICUs.
(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.
(3) A cost-effectiveness analysis of the pathway.
Number of Subjects
Effectiveness: We estimate a total of 18816 mechanically ventilated patients will be 
included with 11424 patients pre-implementation and 7392 patients post 
implementation. Within these patients we estimate a total of 2688 sustained ARDS 
patients with 1632 patients pre-implementation and 1056 patients post-
implementation.
Acceptability: We estimate up to a total of 1000 surveys from clinicians and 100 
participants in focus groups. 
Study Population
All patients admitted to ICU who are mechanically ventilated.
Intervention
A comprehensive evidence-based, stakeholder-informed pathway for the diagnosis 
and management of HRF (Venting Wisely). 
Although the pathway is comprehensive with 46 elements, it focuses on 5 key steps
that promote diagnosis and equitable delivery of life saving intervention:
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
Duration of 
Intervention
The intervention will be implemented into one cluster every two months. Two 
Intensive Care Units will comprise each cluster. The first month of each step will be 
a transition period from usual care, during which data will not be analyzed. Once 
implemented, the cluster will continue to receive it for the remainder of the study.
Reference therapy
Usual management

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Analytic Plan
Clinical Effectiveness :
For the primary outcome, we will compare the mean 28-day ventilator free days pre-
implementation and post-implementation using mixed effects linear regression 
models to account for clustering of patients within site and adjusted for age, sex, 
severity of illness, severity of hypoxemia, type of ICU and size of ICU. We will 
include time (days) in models to account for secular trends over time. Differences in 
secondary outcomes will be similarly analyzed using mixed effects linear and logistic 
regression models, as appropriate.
Implementation (fidelity):
Quantitative assessment of fidelity will be tracked using a composite fidelity score 
that reflects adherence to the five key steps of the pathway. Differences in fidelity 
outcomes pre-implementation and post-implementation will be analyzed similarly to 
the effectiveness clinical outcomes using mixed effects regression models.
Implementation (acceptability):
Survey data will be presented as aggregated frequencies with proportions. Data will 
be stratified by participant profession, years of experience, and type of institution. 
Differences will be compared using Fisher’s exact test or Chi-squared test for 
categorical variables, or the Wilcoxon rank-sum test or Kruskal Wallis test for Likert 
scale data, as appropriate. 
Focus groups will be audio taped, transcribed verbatim, de-identified, imported into 
NVivo10 for data management and independently coded by two investigators, 
drawing on qualitative thematic analysis to identify themes and sub-themes.
Cost-Effectiveness (economic analysis):
The trial-based analysis will be based on cost per ventilator free day saved and will 
be captured within the implementation-based analysis for all patients. 
Hospitalisation costs from the index admission will be estimated using micro-
costing data and physician visits will be estimated using physician claims and billing 
codes. Uncertainty will be assessed using non-parametric bootstrap estimates to 
derive 95% confidence interval and mean cost differences between the treatment 
arms.
The decision analytic model will use the observed effectiveness and discharge 
disposition from the trial to model the expected trajectory over the lifetime of the 
patient. A probabilistic analysis will be done with the mean expected QALYs and 
costs calculated for each treatment. The incremental cost per QALY will be 
calculated with the 95% confidence eclipse.

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Table of Contents
1
STUDY SUMMARY...........................................................................................................................................I
2
TABLE OF CONTENTS................................................................................................................................II
3
LIST OF ABBREVIATIONS.........................................................................................................................IV
4
INTRODUCTION AND BACKGROUND ....................................................................................................1
4.1
INTRODUCTION........................................................................................................................................................... 1
4.2
BACKGROUND ............................................................................................................................................................. 1
4.2.1
The problem ............................................................................................................................................................... 1
4.2.2
The potential solution: a comprehensive, multidisciplinary, evidence-informed care pathway............................................... 1
4.2.3
Foundational Work.................................................................................................................................................... 2
5
OBJECTIVES AND HYPOTHESIS............................................................................................................... 3
6
STUDY METHODS ......................................................................................................................................... 4
6.1
STUDY DESIGN............................................................................................................................................................. 4
6.2
SETTING........................................................................................................................................................................ 4
RANDOMIZATION........................................................................................................................................................ 4
6.3
4
6.4
DURATION OF INTERVENTION.................................................................................................................................. 5
6.5
STUDY DURATION....................................................................................................................................................... 5
6.6
DISCONTINUATION..................................................................................................................................................... 5
6.7
PATIENT POPULATION................................................................................................................................................ 5
6.7.1
Inclusion Criteria........................................................................................................................................................ 5
6.7.2
Exclusion Criteria...................................................................................................................................................... 5
6.8
INTERVENTION............................................................................................................................................................ 5
6.9
IMPLEMENTATION OF THE INTERVENTION............................................................................................................. 7
6.10
TAILORING OF THE INTERVENTION AND IMPLEMENTATION ............................................................................... 7
6.11
CONTROL GROUP......................................................................................................................................................... 8
6.12
OUTCOMES................................................................................................................................................................... 8
6.12.1
Effectiveness Outcomes ................................................................................................................................................ 8
6.12.2
Implementation Outcomes............................................................................................................................................ 8
6.12.3
Economic Outcomes .................................................................................................................................................... 9
7
DATA.................................................................................................................................................................10
7.1
DATA ACCESS.............................................................................................................................................................10
7.1.1
Effectiveness..............................................................................................................................................................10
7.1.2
Implementation.........................................................................................................................................................10
7.2
DATA TRANSFER, ENCRYPTION, AND STORAGE...................................................................................................11
7.2.1
Clinical Effectiveness Data........................................................................................................................................11
7.2.2
Implementation Data................................................................................................................................................12
8
ANALYTIC PLAN ...........................................................................................................................................13
8.1
CLINICAL EFFECTIVENESS .......................................................................................................................................13
8.1.1
Primary clinical analysis and sample size determination...............................................................................................13
8.2
IMPLEMENTATION.....................................................................................................................................................13
8.2.1
Primary clinical analysis and sample size determination:..............................................................................................13
8.2.2
Cost-Effectiveness Analysis .......................................................................................................................................14
9
ETHICAL CONSIDERATIONS ...................................................................................................................15
9.1
WAIVER OF CONSENT TO ACCESS FEASIBILITY OUTCOME DATA.........................................................................15
9.2
IMPLIED AND EXPLICIT CONSENT FOR SURVEY AND FOCUS GROUPS.................................................................15
10
FINANCE.........................................................................................................................................................16
11
REPORTING GUIDELINES AND PUBLICATION PLAN.....................................................................16

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SUPPLEMENTS..............................................................................................................................................17
13
REFERENCES ...............................................................................................................................................18

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List of Abbreviations
DCCM 
Department of Critical Care Medicine
HRF
Hypoxemic Respiratory Failure
ARDS
Acute Respiratory Distress Syndrome
ICU
Intensive Care Unit
CHREB
Conjoint Health Research Ethics Board
ECLS
Extracorporeal Life Support
PEEP 
Positive End Expiratory Pressure 
PF ratio
PaO2/FiO2 or the arterial oxygen partial pressure to fractional inspired oxygen
HREB
Health Research Ethics Board
LOS 
Length of Stay 
EMR 
Electronic Medical Record
CIS 
Clinical Information System
HIA 
Health Information Act 
QALY 
Quality Adjusted Life Year 

4
Introduction and Background
4.1
Introduction
The Department of Critical Care Medicine in Calgary in partnership with the Department of Critical Care Medicine 
in Edmonton as well as the Alberta Critical Care Strategic Clinical Network is planning to implement a screening 
and management pathway for patients with and at risk of Hypoxemic Respiratory Failure (HRF) and acute 
respiratory distress syndrome (ARDS) across all 17 ICUs in Alberta. The intervention (Venting Wisely pathway) will 
be implemented in all adult ICUs within Alberta and the therapies within the pathway (including proning) are 
routinely used within adult Alberta ICUs and define what should be standard of care. A pilot study to assess 
feasibility and acceptability of the Venting Wisely pathway in one Intensive Care Unit (ICU) was completed in 
September 2020.
We are applying for CHREB approval to: 
(1) Collect patient data to assess effectiveness and cost-effectiveness of the pathway as well as fidelity to the 
delivered interventions. 
(2) Conduct a survey and focus groups post implementation to assess acceptability of the pathway for 
clinicians. 
4.2
Background
4.2.1
The problem
Hypoxemic respiratory failure (HRF) and its most severe subtype, the acute respiratory distress syndrome (ARDS), 
are common and associated with considerable attributable morbidity and mortality among patients admitted to the 
Intensive Care Unit (ICU). (1-4) Acute HRF, defined as an arterial to inspired oxygen (PF) ratio ≤300, is common 
in critical care and occurs in approximately 15% of ICU admissions.(1, 2) For HRF patients who meet criteria for 
ARDS (bilateral infiltrates due to non-cardiogenic pulmonary edema, acute onset, and a known risk factor) 
approximately 40% will not survive to hospital discharge.(1, 2) Those who survive, suffer significant long-term 
functional disability.(5, 6) In addition to its burden on patients and families, HRF is associated with significant 
health care resource utilization.(5, 7)
Life-saving therapies for HRF and ARDS exist but are not consistently provided.(1, 2) Three interventions in 
particular have been shown to save lives: Lung Protective Ventilation (LPV), neuromuscular blockade (paralysis), 
and prone positioning.(8-12) Guidelines endorsing the use of these therapies exist; however, implementation is 
extremely inconsistent owing to challenges with diagnosis (particularly for ARDS), and ineffective knowledge 
translation.(1, 11, 13-20) Female patients with HRF are less likely than their male counterparts to receive life-
saving, evidence-based therapies.(2, 21) In addition to inconsistent use of life-saving therapies, there is frequent use 
of unproven, invasive, and resource intensive therapy (e.g. extracorporeal membrane oxygenation; inhaled
pulmonary vasodilators) rather than proven and less resource intensive therapies such as prone positioning.(1, 2, 
22)
4.2.2
The potential solution: a comprehensive, multidisciplinary, evidence-informed care pathway
To bridge the knowledge-to-action gap, and equitably and rationally deliver life sustaining therapies for HRF 
patients, The Department of Critical Care Medicine in Calgary in partnership with the Department of Critical Care 
Medicine in Edmonton as well as the Alberta Critical Care Strategic Clinical Network is implementing an evidence-
based, stakeholder-informed care pathway. The pathway (see Attachment 1) will standardize the diagnosis and 
management of patients with HRF with the goal of reducing practice variation and improving adherence to 
evidence-informed therapy. As noted above, pilot implementation of the pathway was conducted in one ICU. Full 
implementation of the pathway across Alberta is projected to begin in April 2021.

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4.2.3
Foundational Work
1 - Building Essential Infrastructure. From 2010-2012, we conducted a registry-based (eCritical) HRF screening 
program (4 ICUs, Calgary) that successfully identified patients with HRF and ARDS. An updated registry based 
“HRF screening module” has been incorporated into the Venting Wisely pathway as well as our electronic medical 
record (both eCritical and Connect Care).
2 - Retrospective Review. Utilising eCritical registry data, we retrospectively reviewed the incidence, care practices 
and outcomes of HRF patients (Calgary) (2) and found significant practice variability. See previous CHREB
approval Ethics ID number REB17-0941. 
3 - Systematic Review. We conducted a systematic review to examine the effect of standardized pathways on 
survival in patients with HRF.(23) We demonstrated that the pooled relative risk of mortality was reduced by 23% 
in patients treated with standardized care in comparison to usual management (RR 0.77, 95% CI 0.65-0.91, 12 
studies with 5031 patients). However, these studies had significant limitations due to high risk of methodological 
bias, none evaluating an evidence informed pathway, and none tracking implementation fidelity. Our proposed 
study will address many of the limitations identified in these studies.
4 - Pathway Developed. We brought together a multidisciplinary group of 31 
clinicians (physicians  (MD), respiratory therapists (RT), and nurses (RN) to 
develop a pathway of care for the diagnosis and treatment of HRF and ARDS 
using a modified Delphi consensus process (24) and recent evidence-based 
guidelines on HRF.(13, 14, 25) This evidence-informed applied 5-step 
pathway (Figure 1) aims to improve diagnosis and reduce evidence-care gaps 
by emphasizing the appropriate use of lifesaving therapies (lung protective 
ventilation, paralysis and prone positioning), while de-emphasizing less 
efficacious treatments. See previous CHREB approval Ethics ID number 
REB17-1053.
5 - Pathway Validated. We surveyed ICU clinicians across Alberta to assess 
face validity of the pathway.(24) Over 700 ICU clinicians (including 
physicians, RTs, and nurses, from tertiary, community, and rural ICUs) 
responded. Consensus (>80% agreement) was achieved on 43 of 45 
pathway elements. See previous CHREB approval Ethics ID number 
REB17-1053 MOD2.
6 - Barrier and Facilitators Assessment. We surveyed clinicians (RN/RT/MD) working in diverse ICUs (tertiary, 
community, and rural) to identify barriers and facilitators to pathway implementation. We mapped these barriers to 
the Behaviour Change Wheel (COM-B) and Theoretical Domains Framework.(26, 27) Our implementation strategy will 
specifically target these barriers. See previous CHREB approval Ethics ID number REB17-1053 MOD2.
7 - Pilot Study. We have conducted a single center before-after pilot study to assess feasibility and acceptability of 
the pathway (ClinicalTrials.gov NCT04070053).(28) See previous CHREB approval Ethics ID number REB19-
0939.
Figure 1 – Venting Wisely Pathway 

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5
Objectives and Hypothesis
The overall objective of this study is to improve the quality of care for patients with HRF by implementing a 
rigorously developed, evidence-based, stakeholder-informed, multidisciplinary standardized care pathway called 
Venting Wisely that standardizes the diagnosis and delivery of life-saving therapies for critically ill patients with 
HRF.
The specific objectives are to evaluate:
(1) Clinical Effectiveness of the pathway using a pragmatic registry-based cluster randomized stepped-wedge 
implementation study involving 17 ICUs. 
(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.
(3) A cost-effectiveness analysis of the pathway.
We hypothesize that the pathway will increase adherence to life-saving therapies, improve patient outcomes, and save 
costs within the health care system. 

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6
Study Methods
6.1
Study design
The study is designed as an effectiveness-implementation hybrid study design (type 1).(29) This study design 
evaluates both clinical effectiveness and implementation of the pathway, but is primarily powered to the primary clinical 
effectiveness outcome. Implementation will occur via a pragmatic registry-based stepped wedge cluster 
randomized implementation study. 
6.2
Setting 
The study will be conducted at 17 adult ICUs in Alberta, Canada. These 17 ICUs comprise a mix of tertiary, 
community and rural ICUs as listed in Attachment 2. One ICU (Calgary) served as the setting for a pilot study 
(completed September 2020). The remaining 16 ICUs will participate in the full study.
6.3
Randomization
The unit of randomization will be a cluster. Two ICUs will comprise each cluster. Each ICU will be randomly 
assigned to one of the 8 clusters using a computer-generated random number sequence to initiate the intervention 
at different times according to the stepped wedge allocation schedule (See Figure 2).  Sites will be randomized 
using computer generated random number sequence by a blinded investigator. Details of the randomization 
method are held securely in the statistics master file. Two sites will be selected at any time. ICU sites will be 
excluded in a randomization step if critical unreadiness events are identified which would include, extreme Covid-
19 demands, transition to a new Clinical Information System, and Provincial ICU accreditation. Sites will be 
randomized and notified four to eight weeks prior to the initiation schedule to prevent contamination.
Figure 2 – TheraPPP Study 

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6.4
Duration of Intervention 
The intervention will be implemented into one cluster (two ICUs) every two months. The first month of each step 
will be a transition period from usual care, during which data will not be analyzed. Once implemented, the cluster 
will continue to receive it for the remainder of the study.
6.5
Study Duration 
There will be a 10-month baseline data collection period at the beginning of the study. There will be a four month 
follow up period after implementation of the final cluster. The total study duration will be 29 months (Figure 2).
6.6
Discontinuation
On completion of the study, the pathway will remain in place as standard of care. Patients already on the pathway 
will continue with pathway management and their data will be collected as part of the study until hospital 
discharge.
6.7
Patient Population 
6.7.1
Inclusion Criteria
All patients admitted to the adult ICU will be screened for eligibility for the pathway. All mechanically ventilated 
patients admitted to the ICU will be included in the study and receive the pathway intervention. Physician approval 
will not be required. Patients admitted to ICU but cared for in non-traditional ICU settings due to Covid surges 
(Coronary Care Units, Post-operative care units) will be included even if manual data extraction is required.
6.7.2
Exclusion Criteria
There are no exclusion criteria for entry into in the pathway; however, however not all steps will be applicable to 
all patients.
6.8
Intervention 
The intervention is a comprehensive evidence-based, stakeholder-informed pathway for the diagnosis and 
management of HRF called Venting Wisely. Although the Venting Wisely pathway is comprehensive with 46 
elements, it focuses on 5 key steps that promote diagnosis and equitable delivery of life saving interventions 
(Figure 3). See Attachment 1 and 3 for the full Venting Wisely pathway.
Figure 3 – Venting Wisely Pathway

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Step 1. All mechanically ventilated patients will have a height measured and documented
The prescribed tidal volumes on the ventilator are dependent upon an estimation of lung size using the predicted 
body weight.(9)  The predicted body weight is calculated using the height and sex of the patient.(9) Measurement 
and documentation of height will be conducted by Registered Respiratory Therapists (RTs) and will be able to 
independently execute step 1 (without physician approval).
Step 2. Screening for HRF
All patients admitted to the intervention ICUs will be screened for the presence of HRF through analysis of an 
arterial blood gas obtained during steady state (performed as a standard of care between midnight and 0800 and 
after a period of at least 30 minutes with no changes in ventilator settings or patient position). If the arterial to 
inspired oxygen ratio (PaO2:FiO2 or PF ratio) is ≤300, the patient is deemed to have met HRF criteria. Patients 
with HRF will continue to step 3 in the pathway. Those patients who do not meet HRF criteria will repeat step 2 
and be rescreened for HRF at 0800 daily until they either meet criteria for HRF or they improve and are liberated 
from mechanical ventilation. HRF screening will be conducted by RTs. In the event an arterial blood gas is not 
obtainable (e.g. no arterial line), a non-invasive approach using pulse oximetry and the SpO2:FiO2 ratio will be 
used as previously described.(30-32) RTs will be able to independently execute step 2.  
Step 3. Initiate Lung Protective Ventilation (LPV)
For patients with HRF, RTs will initiate LPV using pressure- and volume-limited ventilation in a controlled mode 
of ventilation (e.g. volume or pressure control). LPV includes limiting initial tidal volumes to 6-8 mL/kg predicted 
body weight and limiting the plateau pressure to ≤30 cm H2O. To prevent inappropriately high tidal volumes in 
patients where the predicted body weight method is likely to overestimate lung size, such as in women or patients 
with short stature, driving pressure will be limited to ≤18 cm H2O.(33) RTs will document mechanical ventilation 
goals daily during bedside rounds. Adjunctive measures in step 3 include consideration of a negative fluid balance 
goal to minimize lung edema, the use of recruitment maneuvers to improve atelectasis and reduce dead space 
ventilation, and intensification of sedation to minimize spontaneous or dyssynchronous ventilation (see 
Attachment 3 for details). RTs will be able to independently execute the core parts of step 3, not adjunctive 
therapy.
Step 4. Paralysis
For patients that develop worsening HRF or do not meet LPV goals, therapy will be escalated, beginning with the 
addition of neuromuscular blockade (pharmacological paralysis). For patients with a PF ratio ≤ 150, 
pharmacological paralysis will be suggested and for patients with a PF ratio ≤ 100, pharmacological paralysis will 
be strongly recommended. Paralysis will continue for periods of 24 hours or until criteria are no longer met. 
Patients whose HRF is due to a diagnosis not consistent with ARDS (commonly cardiogenic pulmonary edema, 
unilateral pneumonia, or pulmonary embolism) will be excluded from this step. Physician approval will be required 
prior to initiating paralysis.
Step 5. Prone Positioning
Patients with a worsening PF ratio despite steps 1-4 will be considered for prone positioning. This will be 
suggested for patients with a PF ratio ≤ 150 and on an FiO2 ≥ 0.60 (as applied in the RCT that demonstrated its 
lifesaving ability(34) and strongly recommended for patients with a PF ratio ≤ 100 and on an FiO2 ≥ 0.60. Prone 
positioning of the patient will be performed as per local unit policy and subject to standard exclusion criteria (e.g. 
diagnosis not consistent with ARDS such as cardiogenic pulmonary edema, unilateral pneumonia, and pulmonary 
embolism). Prone positioning will be maintained for 16-hours and repeated daily until criteria for its initiation are 
no longer present. Physician approval will be required prior to initiating prone positioning.
Rescue Therapies
Patients that do not respond to steps 1-5, will be considered for rescue therapies (e.g. referral for extracorporeal 
life support).

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6.9
Implementation of the Intervention 
Implementation will include eight key strategies including education, decision-support, reminders, audit and
feedback, training, champions, implementation support, and empowerment (Attachment 4 for detailed strategy). 
Selected implementation strategies were informed by our assessment of contextual barriers and facilitators, which 
were mapped to the Capability Opportunity Motivation – Behaviour (COM-B) components and Theoretical Domains 
Framework of the Behaviour Change Wheel. The most common barriers identified include lack of skill or knowledge, 
lack of perceived benefit, and lack of opportunity to implement. The implementation strategies chosen specifically 
target these barriers and been previously reviewed and utilised by our team members in the Critical Care setting 
(e.g., lack of knowledge barrier targeted by education rounds).(35-39) Furthermore, feasibility of the 
implementation strategy was demonstrated by our pilot study. Implementation will be delivered by a 
multidisciplinary group of pathway champions (nurses, RTs and physicians). 
Education: The principal investigator, implementation team, and pathway champions will conduct up to weekly 
inservice/interactive rounds for clinicians (Attachment 5) during the implementation period at each site.
Clinical decision-support tools: A clinical pathway guideline document has been developed to provide granular 
operational details for each pathway step. Clinical support tools have also been built into the eCritical/Connect 
Care user interface where RTs document elements of the pathway, to provide decision support (Attachment 6).
Reminders: RTs and nurses will be empowered to discuss pathway management suggestions during daily bedside 
rounds. RT supervisors and educators will audit adherence to the pathway and offer feedback to the respiratory 
care team. Direct reminders will include printed posters, digital pathways (smart phone compatible PDF), and 
laminated pocket cards. 
Audit and feedback: Data will be abstracted from eCritical, synthesized and provided to clinician leadership (run 
chart) on a monthly basis with fidelity tracked to follow improvement (See Fidelity 6.12.2).
Training: Training via inservices, simulation, guidelines, and coaching will be provided for challenging pathway 
interventions; for example, prone positioning. Repetition with certification will be encouraged.
Champions: Respected pathway champions will provide education, training, support, and audit and feedback. 
ICUs who have successfully implemented the pathway, support and share lessons and expertise with onboarding 
ICUs.
Implementation support: Champions and implementation teams will collaboratively problem solve barriers to 
performing pathway interventions such as limited human and physical resources. Champions at successfully 
implemented sites will share ways in which other sites have dealt with similar challenges. If an intervention is 
critical to the pathway, the implementation team will attempt to make it available or develops workarounds.
Empowerment: Education will be made available to all disciplines to empower “out of scope” conversations. 
Prompts will be available to cue all members of the team toward evidence informed care. Champions will reinforce 
the ability to expand roles. Clinical decision support will empower RTs and RNs to suggest treatment options. 
Concerns regarding expansion of roles may be alleviated as audit and feedback demonstrates improvement in 
adherence to the evidence-informed care,
6.10 Tailoring of the intervention and implementation
Team leads at each site have been identified. Assessment of individual ICU characteristics (patient volumes/mix, 
staffing) and readiness has been conducted to tailor the intervention for implementation based on local contextual 
factors (i.e. timing of screening based on RT availability at night in community ICUs). Learnings from the pilot 
study continue to be incorporated into the implementation strategy. Further tailoring of the intervention will be 
conducted during the 1-month implementation transition phase for each ICU.

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6.11
Control group
ICUs in the control group will continue with usual management. Implementation strategies including education, 
decision-support, reminders, audit and feedback, training, champions, implementation support, and empowerment
will be restricted to intervention ICUs to prevent contamination. 
6.12 Outcomes
6.12.1
Effectiveness Outcomes
Primary clinical effectiveness outcome:
28-day ventilator free days. This is a composite outcome of survival and days spent not ventilated over the first 28 
days.
Secondary clinical effectiveness outcomes:
1) 28-day hospital survival (censored at hospital discharge), hospital survival (censored at 90 days), and ICU survival
2) Ventilator duration is the number of ventilated days
3) Driving Pressure (Plateau pressure – Positive End Expiratory Pressure (PEEP))
4) Mechanical power (0.098*respiratory rate•*(tidal volume/1000)*(Peak Pressure  – (0.5 • Driving Pressure) 5) Length 
of Stay (LOS). ICU LOS and hospital LOS (censored at 90 days). We consider LOS both a clinical and economic 
outcome. 
6) Utilization of veno-venous Extracorporeal Membrane Oxygenation (VV-ECMO) 
All of the above measures are captured electronically in eCritical. See Attachment 7 for further details of data 
sources and data linkage.
6.12.2
Implementation Outcomes
A process evaluation of the Venting Wisely pathway implementation will be conducted using multi-methods to 1) 
quantitatively evaluate fidelity of the intervention, 2) qualitatively assess acceptability and 3) use these results to 
iteratively refine the pathway and implementation strategy. The process evaluation will provide vital information 
on why the implementation may or may not have worked as anticipated (type III error), identify opportunities for 
iteratively improving pathway fidelity, as well as insights for future sustainability and scalability to other ICUs 
nationally and internationally.
Primary implementation outcome:
Composite fidelity score. The primary implementation outcome is a composite score (out of 5) that is calculated daily 
and assesses adherence to the 5 key steps.
Secondary implementation outcomes (fidelity):
Secondary fidelity outcomes are individual process of care indicators that reflect the five key steps of the pathway:
1) Proportion of patients ventilated with a height ever documented (step 1) 
2) Proportion of eligible patient days with PF 300 who receive a tidal volume  8mL/kg predicted body weight
(step2/3)
3) Proportion of eligible patient days who have a plateau pressure measured (step 3)
4) Proportion of eligible patient days who receive neuromuscular blockade (step 4)
5) Proportion of eligible patient days receiving prone ventilation (step 5).
Fidelity process of care indicators will also be used to improve pathway adherence through audit and feedback 
reports, (see 6.9).  
Secondary implementation outcomes (acceptability):
Secondary acceptability outcomes are based on the seven component constructs of the Theoretical Framework of Acceptability 
(TFA) listed below. These are measured on a five-point Likert scale, with a median of four or above indicating
agreement.

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1) The Composite acceptability score is the proportion of the seven TFA constructs on the acceptability survey graded 
with a median score of four or above from a 5-point Likert scale, indicating agreement 
2) Intervention coherence (the extent to which the clinician (physician, RT, or RN) understands the intervention)
3) Opportunity costs (benefits or costs to the participant for using the pathway)
4) Perceived effectiveness of the pathway (the extent to which the intervention is perceived as likely to achieve its 
purpose)
5) Self-efficacy (clinician’s confidence that they can use the pathway)
6) Affective attitude (how a clinician feels about the intervention)
7) Burden (the perceived amount of effort that is required to participate in the intervention)
8) Ethicality (the extent to which the intervention aligns with a clinician’s value system).
6.12.3
Economic Outcomes
Full details of the statistical analysis plan for the economic analysis will be provided in a separate protocol. 
Primary economic outcome:
Cost per ventilator free day saved from the perspective of the health care system over the index hospitalization period. 
Secondary economic outcomes:
1) Total cost for the ICU admission
2) Total cost for the index hospitalization
3) ICU and hospital length of stay
4) Cost per quality adjusted life year (QALY) from the health care system perspective over the patient’s lifetime. 
See Attachment 8 for details on effectiveness and implementation outcomes. 

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7
Data 
7.1
Data Access 
7.1.1
Effectiveness 
Demographic, clinical, and outcome data to evaluate effectiveness will be collected via TRACER which 
prospectively captures data for all patients admitted to Alberta ICUs using an integrated bedside electronic medical 
record (MetaVisionTM, EPIC Connect Care).(40) Data is stored in a repository (TRACER) which can be merged 
with provincial administrative databases maintained by Alberta Health Services. The provincial administrative 
databases include information on all hospitalizations, laboratory data, and orders. Within eCritical, an updated 
HRF screening module will facilitate decision support and data collection for patients who have HRF (Attachment 6). 
Additionally, Sunrise Clinical Manager (SCM) and Connect Care will be accessed to review discharge summaries, 
admission history and labwork. Impax will be used to review chest imaging, Xcelera to review echocardiograms, 
and TRACER to review respiratory and mechanical ventilation parameters.
Manual data extraction with direct access to paper charts will be required to audit data and ensure its integrity, as 
well as acquire missing data for patients cared for in non-traditional ICU settings (Coronary Care Unit, Post-
operative care unit) due to Covid surges. 
Cost-effectiveness data will be acquired from detailed AHS corporate financial databases will be used to calculate 
precise micro-costing estimates for inpatients. All of the above databases have been validated and used to support 
extensive prior research initiatives in Alberta.(39-41)
7.1.2
Implementation 
Fidelity: Fidelity process of care indicators will be collected via eCritical TRACER and EPIC Connect Care as 
described above (7.1.1). 
Acceptability: The target population includes clinicians (physicians, RTs, registered nurses, nurse practitioners) 
who participated in the intervention. Clinicians will be recruited using email addresses associated with eCritical 
login identification and patient care manager staff lists (as per previous studies by our team).(42, 43) Demographic 
data collected (in both survey and focus groups) will include age, gender, years of ICU experience, professional 
designation, and institution to ensure perceptions do not differ by provider characteristics. 
On Surveys, participants will be asked for their perspectives on the acceptability of the pathway and its 
implementation. It will also assess their knowledge of HRF management and recollection of implementation 
strategies. Respondents will use multiple choice responses for best practice questions. Elements of the pathway 
and implementation strategy will be rated using a 5-point Likert scale as previously described by our group.(42, 43)
Participants for the acceptability survey will be identified using patient care manager staff lists for employees 
working during the one month implementation and one year post implementation period. Data will be collected 
via Qualtrics, an online survey tool available to University of Calgary faculty and staff. To thank survey 
respondents and encourage participation, a $200 gift card may be offered to the unit managers of Intensive Care 
Units after clinicians complete at least 30 acceptability surveys per unit.  See Attachment 9 for the acceptability 
survey.
Focus groups will be conducted as previously described by members of our team.(44) Purposive sampling will be 
conducted to ensure homologous representation from clinicians across institutions and with diversity in level of 
experience and primary discipline. Focus groups will be moderated by a trained qualitative research assistant, who 
will follow a semi-structured focus group guide designed to explore participants’ perceptions of the pathway and 
the process of implementation (see draft interview guide, Attachment 10). Each focus group will include an 
introduction to the purpose, an icebreaker exercise, a series of questions which proceed from general to specific, 
and a summary to highlight and verify key points. Domains of inquiry will reflect the seven component constructs 
of the theoretical framework of acceptability(45) and include: 1) intervention coherence (the extent to which the 

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clinician (physician, respiratory therapist, registered nurse or nurse practitioner) understands the intervention, 2) 
opportunity costs (benefits or costs to the participant for using the pathway, 3) perceived effectiveness of the 
pathway (the extent to which the intervention is perceived as likely to achieve its purpose), 4) self-efficacy 
(participant’s confidence that they can use the pathway), 5) affective attitude (clinician’s confidence that they can 
use the pathway), 6) Burden (the perceived amount of effort that is required to participate in the intervention), and 
7) Ethicality (the extent to which the intervention aligns with a clinician’s value system). The focus group guide will 
be pilot-tested on a small group of specialty-specific stakeholders to refine wording and flow of questions. As we 
will use an iterative approach to data analysis, questions may be added or subtracted as the study progresses. A $50 
gift card may be offered to all focus group participants to thank them for their time and mitigate recruitment
challenges. See Attachment 10 for the focus group interview guide.
7.2
Data Transfer, Encryption, and Storage
7.2.1
Clinical Effectiveness Data
Data handling, record keeping, and confidentiality. Data collected from the Electronic Medical Record (eCritical 
MetaVision, EPIC Connect Care) will be accessed by only one member of the team. Direct access to paper charts 
will be required to audit the integrity of registry acquired data and manually collect data for a small proportion of 
patients cared for in non-traditional ICU settings during Covid surges. Patient charts will not leave the hospital 
where they are made available to the study team. Manually collected data will be entered into REDCap, a secure 
web application for building and managing online databases. No patient names will be entered into any database 
associated with patient data. Only one encrypted excel spreadsheet with patient record numbers and corresponding 
anonymized numbers will be kept on a password-protected Alberta Health Services Server in a locked office of the 
principal investigator/Senior Biostatistician (Andrea Soo). In a completely separate encrypted excel spreadsheet, 
the anonymized patient numbers will have corresponding patient data such as vitals, blood work, or imaging. All 
data abstracted will remain saved on the AHS protected and secure internal computer drive, encrypted and 
password protected. This data will be compiled as averages or total sums of all patients in the study if 
published. No individual patient data or lab values that could lead to identification will ever be disclosed.
Data available in the registries and databases will be abstracted by employees of eCritical/TRACER Alberta and 
DIMR. eCritical will assign a unique de-identified number in the initial database extract, in addition to identifying 
numbers (MRN/PHN). For paper charts, the Senior Biostatistician Andrea Soo will assign a random de-identified 
number. Identifying information will be stored within the data files until the data extracted from different 
repositories (eCritical) is linked through DIMR. The data files returned to the research team will be de-identified
except for the MRN. The purpose of obtaining the MRN from the AHS analyst is to link 10% of patient charts 
(eCritical MetaVision, EPIC Connect Care) with eCritical TRACER data. This will allow us to manually audit these 
patient charts (eCritical MetaVision, EPIC Connect Care) to ensure the data variables that are electronically pulled 
from eCritical TRACER are the same data that we are looking at manually in eCritical MetaVison and EPIC 
Connect Care. Only one member of our team, Andrea Soo, Senior Biostatistician, will have access to eCritical 
TRACER MRNs. Subsequent to the linking of patient charts with eCritical TRACER data, the identifying 
information (MRN) will be removed from our database.
The databases will be stored on a secure AHS server in a password protected file a single secure password-
protected AHS computer in a locked office (held by the study biostatistician). Data will only be presented in 
aggregate.
Meetings between the principal investigator and all other investigators have been held. Confidentiality and ethics 
have been discussed at these meetings. We will continue to hold regular meetings for this research project, where 
the importance of confidentiality for this study will be emphasized.
Records Retention: All identifiable data will be destroyed 5 years after publication. Patient charts will remain in the 
possession of Alberta Health Services.

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Regulatory Binder:  The authors will keep a regulatory binder with all information pertinent to this study.
7.2.2
Implementation Data
Data handling, record keeping, and confidentiality:
Fidelity: Fidelity process of care indicators collected via eCritical TRACER will be handled and retained as detailed 
above for effectiveness data (See 7.2.1).
Acceptability: Surveys will be administered via Qualtrics, an online survey tool, made available through the 
University of Calgary institutional license. Survey data collected through Qualtrics online survey tool is stored on 
servers located in Canada. Qualtrics uses advanced technology for internet security including but not limited to 
authentication, password, single-user sign on, and data encryption.
Focus groups will be conducted via the videoconferencing platform (Zoom) through a University of Calgary 
institutional account. The focus groups will be audio recorded using the Zoom recording feature as well as via a 
physical, handheld recorder (as backup). We are audio recording the focus groups to produce a written transcript 
for data analysis. All focus group audio recordings will be transcribed verbatim by a member of the research team 
or professional transcription service (REV.com) and be de-identified (remove identifying information and use 
pseudonyms when needed). The de-identified datasets (audio-recordings and transcriptions from focus groups) will 
be saved on the AHS password protected and secure computer server. The files will be encrypted and password 
protected also. No individual clinician data that could lead to identification will ever be disclosed.
No results or records of surveys or focus groups will be identifiable to the stakeholders involved in the study. Only 
one encrypted excel spreadsheet with participant and corresponding anonymized numbers will be kept on a 
password-protected computer in a locked office of the principal investigator. All data abstracted and synthesized 
will remain saved on the AHS protected and secure internal computer drive, encrypted and password protected. 
This data will be compiled as averages or total sums of all participants in the study if being published. 
Records Retention: All identifiable data will be destroyed 5 years after publication. 

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8
Analytic plan
8.1
Clinical Effectiveness
8.1.1
Primary clinical analysis and sample size determination
Based on historical ICU admission rates in Alberta from 2018-2019, we estimate a total of 18816 mechanically 
ventilated patients will be included in this study with 11424 patients pre-implementation and 7392 patients post 
implementation. Based on this, a baseline mean VFDs of 21 (SD 10), a 90% power and a two-sided α=0.05 we 
estimate an ability to detect a difference of 0.9 VFDs (see Statistical Analysis Plan). To estimate the ARDS 
population within this cohort, we applied a population-based incidence of ARDS that was derived within Calgary 
using standardized screening for ARDS.  Using this historical population-based incidence, we anticipate an average 
of 12 ARDS patients per 2-month period per site (based on our observed ARDS incidence of 0.42 per bed per 
month in Calgary).(2) Based on the stepped wedge design (8 clusters, with initiation of a new cluster every 2 
months, a 10-month pre-period and a 4-month post period) we estimate that this will generate a sample size of 
2688 sustained ARDS patients within the study cohort with 1632 ARDS patients pre-implementation and 1056 
ARDS patients post-implementation. For the primary outcome of 28-day ventilator free days, we currently observe 
a mean 28-day ventilator free days (per patient) of 11 days (standard deviation of 10 days). This number of patients 
will provide the ability to detect a difference of 2.4 days (11 to 13.4) in the mean 28-day ventilator free days (with a 
90% power and a two-sided α=0.05, ICC = 0.01). The power calculation was performed using the Stata function 
“steppedwedge”. (46, 47)  An expanded rationale and modelling for the sample size is provided within the 
Statistical Analysis Plan.
Clinical outcomes will be analyzed at the patient-level and will account for the clustering of patients within ICUs. 
For the primary analysis, we will compare the mean 28-day ventilator free days pre-implementation and post-
implementation using mixed effects linear regression models to account for clustering of patients within site. 
Differences in secondary outcomes pre and post-implementation will be analyzed using mixed effects linear and 
logistic regression models accounting for clustering of patients within site, as appropriate. Models will be adjusted 
for age, sex, severity of illness (sequential organ failure assessment score on admission) and severity of hypoxemia 
(mild, moderate, or severe on diagnosis of HRF as defined using Berlin criteria), as well as type and size of 
ICU.(48) We will include time (days) in the models to account for secular trends over time, since failure to include 
such time effects can bias estimates of effect sizes. Data from the 1-month implementation transition phase within 
each step will not be included in the analysis of primary and secondary outcomes.
Additional details of the analysis plan, including detailed outcome definitions, pre-planned subgroup and sensitivity
analyses can be found in the Statistical Analysis Plan.
8.2
Implementation
8.2.1
Primary clinical analysis and sample size determination: 
Fidelity: Differences in fidelity outcomes pre-implementation and post-implementation will be analyzed similarly to 
the effectiveness clinical outcomes using mixed effects regression models.
Based on the sample of 2688 sustained ARDS patients (calculated for the primary clinical outcome) and a baseline 
mean Composite Fidelity Score (CFS) of 56% (standard deviation of 29%), this study will be powered to detect a 
minimum difference of 7.1% (56% to 63.1%) in the mean CFS score (with 90% power and a two-sided α=0.05, 
ICC=0.02) in patients with sustained ARDS.  
Acceptability Surveys: Invitations will be sent to clinicians (nurse practitioners, nurses, physicians, and RTs) two to 
six months post implementation in each cluster. Based on our pilot study/previous work,(24) we anticipate a 

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conservative response rate of 50% (625 surveys completed of 1250 distributed) which will provide 95% binomial 
confidence intervals of ±3.9%. 
Survey data will be presented as aggregated frequencies with proportions. Data will be stratified by participant 
profession, years of experience, and type of institution. Differences will be compared using Fisher’s exact test or 
Chi-squared test for categorical variables, or the Wilcoxon rank-sum test or Kruskal Wallis test for Likert scale 
data, as appropriate. All analyses will be conducted using statistical software (R, Vienna Austria) and statistical 
significance set at α = 0.05.
Acceptability Focus Groups: There are no a priori sample size considerations. We plan to conduct up to 17 ICU
site specific focus groups, with up to eight clinicians from one profession per group, ( approximately 100 
participants), although additional groups may be required to achieve theoretical saturation of themes.(49) Focus 
groups will be conducted approximately two to six months post implementation on sites when their Composite 
Fidelity Score is above 70% or 10% above baseline. 
Focus groups will be audio taped, transcribed verbatim, de-identified, imported into NVivo10 for data 
management and independently coded by two investigators with qualitative research experience, drawing on 
qualitative thematic analysis to identify themes and sub-themes.(50) The researchers will begin by reading the 
transcripts to gain familiarity with the content, followed by line-by-line coding and constant comparison analysis. 
They will meet after reviewing every 2 – 3 transcripts to review codes and identify emerging themes; discrepancies 
will be resolved through discussion. All focus group participants will be provided with a copy of the study report 
to review and comment upon as a form of member-checking. 
Qualitative work will be reported using Standards of Reporting of Quality Research guidelines.(51)
8.2.2
Cost-Effectiveness Analysis
Trial-based analysis: cost per ventilator free day saved. Economic data will be captured within the implementation-
based analysis for all patients. We will include both one time and ongoing costs of the intervention (creation of 
materials, ongoing educational activities, website maintenance for education). Hospitalisation costs from the index 
admission will be estimated using micro-costing data, providing a detailed cost per patient including all resources 
consumed during the hospital stay (overhead, drugs, nursing time, and physician fees). Physician visits will be 
estimated using physician claims and billing codes. These data are accessible from provincial administrative 
databases. Uncertainty will be assessed using non-parametric bootstrap estimates to derive 95% confidence interval 
and mean cost differences between the treatment arms. 1000 bias-corrected bootstrap replications (including 
sampling with replacement from the original data) will be conducted to estimate the distribution of a sampling 
statistic to derive 95% confidence intervals. Decision analytic model: Using the observed effectiveness and 
discharge disposition from the trial, we will model the expected trajectory over the lifetime of the patient. Long-
term costs, utilities and survival estimates will be informed by previous work of this team, along with robust 
published Canadian data for ARDS patients (utilities).(2, 6, 52) Following best practices,(53) a probabilistic analysis 
will be done with the mean expected QALYs and costs calculated for each treatment. The incremental cost per 
QALY will be calculated with the 95% confidence eclipse. Full details of the statistical analysis plan for the 
economic analysis will be provided in a separate protocol.

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9
Ethical Considerations
This study will be conducted according to Canadian and International Standards of Good Clinical Practice for all 
studies. Applicable government regulations and University of Calgary research policies and procedures will also be 
followed. This protocol and any amendments will be submitted to the University of Calgary CHREB for formal 
approval to conduct the study (Attachment 11).
The intervention (Venting Wisely pathway) will be implemented in all adult ICUs within Alberta and the therapies 
within the pathway (including proning) are routinely used within adult Alberta ICUs and define what should be
standard of care. All data required in this study is collected as part of standard clinical documentation and will not 
require any additional measurements, and the interventions do not pose any additional risk. As a result, we propose 
to perform the study with a waiver of consent from our local research ethics board. This approach was used 
successfully in our pilot study (Calgary REB-19-0939).
9.1
Waiver of consent to access feasibility outcome data 
To evaluate this initiative we are requesting a waiver of consent for research access to personal health information
based on criteria outlined in the Health Information Act, Section 50 and detailed below. 
(1) Obtaining consent for access to the personal health information is not feasible. We are not part of the 
direct line of care and do not have the resources to get consent from all mechanically ventilated patients in 
the ICU.
(2) We believe the research is of sufficient importance to justify a waiver of consent. The HRF and ARDS 
pathway is an important strategy to provide equitable and rational care to a high mortality patient group. It 
is important to know if they pathway improves patient and health systems as it may become the standard 
of care in Alberta ICUs. 
(3) Adequate safeguards are in place to protect the privacy of personal information collected in the research 
as outlined in section 4.2.1.1.
9.2
Implied and explicit consent for survey and focus groups
The acceptability survey will be prefaced with an implied consent form explaining that participation is voluntary 
and implies consent. See Attachment 12 for the acceptability survey implied consent form. Participation in the 
focus group will be considered explicit oral consent; however, each participant will receive a copy of the consent 
form for their review prior to participation in the interview. See Attachment 13 for the focus group consent form.

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10 Finance 
We have received funding from the Canadian Institutes of Health Research (CIHR) and the Health Innovation 
Implementation and Spread (HIIS 2) grant from Alberta Health and Alberta Health Services. 
11 Reporting guidelines and Publication Plan
The Identification and Treatment of Hypoxemic Respiratory Failure and ARDS with Protection, Paralysis, and 
Proning (TheraPPP Study) is registered on clinicaltrials.gov (NCT04744298) and will be published in a peer-
reviewed journal. Study methods will be conducted and reported in accordance with standards for reporting 
stepped wedge cluster randomised trials (CONSORT, SW-CRT extension),(54) and standards for reporting 
implementation studies(StaRI) (55) and their replication (TIDieR).(56) Qualitative work will be reported using 
Standards of Reporting of Quality Research guidelines (SRQR) and Consolidated criteria for Reporting Qualitative 
research (COREQ). (51, 57) The protocol is also reported in accordance with the Standard Protocol Items: 
Recommendations for Interventional Trials (SPIRIT) guidance and checklist 2013(58). 

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12 Supplements
Attachment 1
Pathway diagram 
Attachment 2
Setting (hospital sites)
Attachment 3
Comprehensive HRF and ARDS standardized management (Venting Wisely) pathway
Attachment 4
Detailed Implementation Strategy
Attachment 5
Education example 
Attachment 6
HRF Screening Module
Attachment 7
Data sources and linkage
Attachment 8
Outcomes
Attachment 9
Acceptability survey
Attachment 10
Interview Guide 
Attachment 11
Ethics modifications 
Attachment 12
Acceptability survey implied consent form
Attachment 13
Focus group consent form

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-9-"5-,56&(%&-&7-16&,8&7-16&,-1"1&"%&6U76:#"(%-5&7"*7)01#-%761

 
Attachment 2. Setting – hospital sites  
 
Calgary: 
(1) 
Foothills Medical Centre General Systems Intensive Care Unit (pilot site)  
 
(2) 
Foothills Medical Centre Cardiovascular Intensive Care Unit 
 
(3) 
Rockyview Hospital ICU General Systems Intensive Care Unit 
 
(4) 
Peter Lougheed Hospital General Systems Intensive Care Unit 
 
(5) 
South Health Campus General Systems Intensive Care Unit 
 
Edmonton: 
(6) 
University of Alberta Hospitals (UAH) General Systems Intensive Care Unit 
 
(7) 
University of Alberta Hospitals (UAH) Neuro-Intensive Care Unit  
 
(8) 
Mazankowski Alberta Heart Institute Cardiovascular Intensive Care Unit  
 
(9) 
Grey Nuns Community Hospital Intensive Care Unit 
 
(10) Misericordia Community Hospital Intensive Care Unit 
 
(11) Royal Alexandra Hospital Intensive Care Unit  
 
Lethbridge: 
(12) Chinook Regional Hospital Intensive Care Unit 
 
Medicine Hat:  
(13) Medicine Hat Regional Hospital Intensive Care Unit 
 
Red Deer:  
(14) Red Deer Regional Hospital Centre Intensive Care Unit 
 
St. Albert: 
(15) Sturgeon Community Hospital Intensive Care Unit  
 
Grande Prairie:  
(16) Queen Elizabeth II Hospital Intensive Care Unit  
 
Fort McMurray:  
(17) Northern Lights Regional Health Centre Intensive Care Unit 

TheraPPP Protocol V 2.1
February 14, 2023
REB20-0646
Attachment 3. Venting Wisely comprehensive pathway 
ALL PATIENTS
Within 1 hour of intubation/admission to ICU all mechanically ventilated patients should have documented in electronic 
medical record:
1.
Height
2.
Predicted Body Weight (PBW)
SCREENING
1.
All patients who are mechanically ventilated at midnight (00:00 hrs) AND have a PF ratio less than or equal to 300 on 
ANY arterial blood gas (ABG) should be identified for screening for HRF/ARDS by the RRT
2.
Screening for HRF consists of:
a.
ABG performed at clinical steady state between 00:00 and 08:00 to demonstrate PF ratio less than or equal to 300 
(on a minimum PEEP of 5)
3.
Screening for ARDS consists of the following 3 criteria:
a.
Meeting criteria for HRF (see step 2 above) plus:
b.
Bilateral infiltrates: Screening chest x-ray should be performed and interpreted by intensivist/delegate to 
determine the presence of bilateral infiltrates
c.
Absence of heart failure: Intensivist/delegate appropriately rules out heart failure as the primary cause of HRF
4.
Results of the HRF/ARDS screen (positive or negative) should be reported on daily multidisciplinary rounds by the RRT
5.
Patients should be screened every 24 hours to determine eligibility in the pathway and/or identify applicability of any 
new interventions
GOALS AND EARLY MANAGEMENT
1.
Controlled mode of ventilation should be used for all patients with new onset HRF/ARDS 
2.
On controlled ventilation the following initial “lung protective” goals should be targeted:  
a.
Tidal volume 6-8mL/Kg PBW
b.
Plateau pressure less than or equal to 30 cm H2O
c.
Driving pressure less than or equal to 18 cm H2O (Pplat-PEEP)
3.
Oxygenation and ventilation goals should be defined on patient admission and reviewed on daily multidisciplinary 
rounds. These should be documented by the RRT and intensivist/delegate in the electronic medical record.
4.
Target neutral or negative fluid balance in the absence of contraindications (e.g. unstable hemodynamics, rising 
creatinine, hypovolemia)
5.
Escalation of treatment should be based on:
a.
Increasing FiO2 requirements,
b.
decreasing PF ratio,
c.
worsening respiratory acidosis, and/or
d.
violation of lung protective ventilation (e.g. oxygenating or treating respiratory acidosis by using higher tidal 
volumes, higher plateau pressures, higher driving pressures than accepted)

TheraPPP Protocol V 2.1
February 14, 2023
REB20-0646
MONITORING AND BASIC INTERVENTIONS
Monitoring Plateau and Driving Pressures
1.
Measure a plateau and driving pressure on all patients with a controlled mode of ventilation (independent of PF ratio, 
Fi02 requirements, or lung compliance)
a.
Initial plateau pressures should be measured within 1H of meeting criteria for HRF 
b.
Should be repeated at least Q12H (consider Q4H)
c.
RRT to determine appropriateness and perform
Sedatives
1.
Consider using sedatives to a target RASS of less than or equal to -3 or to reduce ventilator dyssynchrony
2.
Sedatives may be proposed by any member of multidisciplinary team; however, needs Most Responsible Health 
Practitioner (MRHP) approval prior to initiation. RN to administer and meet sedation goals
Recruitment Maneuvers
1.
Recruitment maneuvers should be routinely assessed for appropriateness
a.
If used, should be performed Q4H
b.
Recruitment maneuvers may be proposed by any member of the multidisciplinary team; however, needs MRHP
approval prior to initiation. RRT to perform
Optimal PEEP Study
1.
A PEEP study should be completed for patients with a PF ratio less than or equal to 200
a.
First PEEP study should be completed within 4H of meeting PF ratio threshold 
b.
Should be repeated Q24H
c.
A PEEP study may be proposed by any member of the multidisciplinary team. RRT to perform
Esophageal balloon
1.
Consider an esophageal balloon to guide/determine both end inspiratory (trans-pulmonary plateau) and end expiratory 
(trans-pulmonary PEEP) pressures (especially if a patient is obese or is suspected to have a stiff chest wall)
a.
Esophageal balloons may be proposed by any member of the multidisciplinary team; however, needs MRHP
approval prior to initiation.  RRT to perform if available

TheraPPP Protocol V 2.1
February 14, 2023
REB20-0646
ADVANCED INTERVENTIONS
Neuromuscular blockade
1.
Neuromuscular blockade:
a.
Consider for patients with a PF ratio less than or equal to 150
b.
Strongly recommend for patients with a PF ratio less than or equal to 100
c.
Goals for neuromuscular blockade (e.g. EtCO2, train of four or ventilator dyssynchrony) should be determined 
by MRHP and documented in the appropriate electronic medical record
d.
Neuromuscular blockade may be proposed by any member of the multidisciplinary team; however, needs 
MRHP approval prior to initiation. RN to administer and meet goals
Proning
1.
Proning:
a.
Consider for patients with a PF ratio less than or equal to 150 AND FiO2 requirement greater than or equal to 
0.60
b.
Strongly recommend for PF ratio less than or equal to 100 AND FiO2 requirement greater than or equal to 
0.60, in the absence of contraindications
c.
Proning may be proposed by any member of the multidisciplinary team; however, needs MRHP approval prior 
to initiation. Multidisciplinary team to enact.
Extracorporeal Life Support (ECLS)
1.
Should be considered as a potential treatment modality for HRF/ARDS only if a patient has a PF ratio less than or 
equal to 100 despite above therapies and in the absence of contraindications
2.
Referral for ECLS may be proposed by any member of the multidisciplinary team; however, needs MRHP approval 
prior to initiation of referral
Inhaled Vasodilators
1.
Routine use of inhaled vasodilators is not recommended; however, they are available on a case by case basis in 
exceptional circumstances

TheraPPP Protocol V 2.1 
February 14, 2023 
REB20-0646 
 
Attachment 4. Detailed Implementation Strategy  
Menu of Implementation Activities  
Implementation Strategy 
Description  
Details  
(1) Education  
 
Distribution of Educational 
material  
 
Web based educational 
materials  
 
Learning modules (linked to on through 
eCritical) 
 
Pathway document with detailed explanation 
in each section  
Educational rounds  
Didactic seminars with 
individual clinician 
groups 
Grand rounds 
Weekly in service seminars for each type of 
clinician  
Educational outreach training 
visits  
Trained person(s) in 
ICU to provide skill 
specific training with 
the intent of changing 
practice  
Champion/Clinician teams with expertise in 
pathway elements will provide hands on 
inservice/training on specific pathway 
elements (ie prone positioning).  
 
(2) Clinical Decision Support  Resources to help 
inform clinicians about 
how to follow pathway 
Pathway document with detailed explanation 
criteria for each step and clinician roles and 
responsibilities 
 
eCritical built in decision support based on 
pathway.  PF ratio will autopopulate suggested 
management in RT documentation section.  
This will allow RT to suggest and remind 
about appropriate therapies at rounds. 
 
(3) Audit and Feedback  
AUDIT: Collect what 
is going on  
FEEDBACK: Use this 
data to target messages 
back to people  
 
 
Audit and feedback on  
(1) Height documented within 24 hours  
(2) Tidal Volume 8mL/kg if PF300 
(3) Plateau Pressure measured if PF300 
(4) Neuromuscular blockade appropriately if 
PF150  
(5) Proning appropriately if PF150 and FiO2 
0.6  
 
Data will be collected through eCritical and 
run charts automatically created.  Local 
pathway champions will provide feedback to 
clinicians 
(4) Reminders  
Charts, checklist, daily 
goals, alarm  
Reminders through local pathway champions 
eCritical Flags 
Pocket Cards, posters, digital pathway (smart 
phone compatible) 
(5) Pathway Champions  
RT, MD, RN 
Champions 
Study team 
Local site leads 
Champions will be local supports, perform 
teaching, and provide audit and feedback to 
remainder of group 
 
(6) Implementation support  
Support is available to 
overcome site barriers   
Implementation team and other sites provide 
support and trouble shoot to overcome 
barriers  

TheraPPP Protocol V 2.1 
February 14, 2023 
REB20-0646 
 
 
 
(7) Empowerment 
Empowered to 
support care toward  
Provide practice guidelines for all pathway 
elements for sites to refine to their context.  
Policies, checklists, and reminders are 
accessible to staff on unit 
(8) Training  
Training and 
simulations 
Training provided for challenging pathway 
interventions 

Attachment 5. Sample slides from educational in-services  
 
TheraPPP Protocol V 2.1 
February 14, 2023 
REB20-0646 
 
 
 
 
 
   
 
 
   
 
 
 
      
 
  
 
 
 
  
 
 
 

Attachment 6. HRF Screening and Data Entry Module 
 
 
 

 
 
 

 

Feb 2023 
REB20-0646 
 
Attachment 7. Data sources and Linkage  
 
 
 
Fig. 1. eCritical system information data flow. Abbreviations: ADT - Admission, Discharge, Transfer; 
CIS - Clinical Information System; PHI - Patient Health Identifier. 
 
Data source descriptions: 
Sunrise Clinical Manager is an enterprise clinical information and electronic order entry system 
implemented in Calgary hospitals. 
 
Edmonton and Calgary ADT systems are the Admission, Discharge and Transfer systems supporting 
Edmonton and Calgary hospitals. 
 
Meditech is an enterprise ADT system and CIS implemented in a number of hospitals in Alberta. 
 
Data, Integration, Measurement Reporting is a service of AHS providing analytic products through data 
integration across multiple provincial information systems. 
 
eCritical MetaVision is the bedside critical care clinical information system that supports standardized 
clinical documentation, electronic data capture from medical devices and clinical decision supports in the 
electronic patient record. 
 
eCritical TRACER is the data warehouse for the critical care clinical information system, supporting clinical 
analytics and reporting functions. 
 
EPIC Connect Care is a clinical information system that is currently being implemented across Alberta Health Services in 9 waves.  
 
Adapted from : Brundin-Mather R, Soo A, Zuege DJ, Niven DJ, Fiest K, Doig CJ, Zygun D, Boyd JM, 
Parsons Leigh J, Bagshaw SM, Stelfox HT (2018) Secondary EMR data for quality improvement and research: 
A comparison of manual and electronic data collection from an integrated critical care electronic medical 
record system. J Crit Care 47:295-301. 
 
EPIC 
Connect 
Care 

Ethics ID: REB20-0646 
Study Title: TheraPPP 
PI: Dr. Ken Parhar 
V3/ Feb 14, 2023 
 
Attachment 8. Primary and secondary effectiveness, fidelity, and acceptability outcomes 
 
Effectiveness Outcomes 
Patient or subgroup 
Timepoints at 
which the 
outcomes are 
measured 
Primary or 
Secondary 
Outcome 
Reporting of results (unit of measurement) 
Clinical effectiveness outcomes 
 
 
 
 
28-day ventilator-free days (VFDs)  
(a composite of survival & days spent not ventilated over the first 28 
days) 
All patients/subgroups 
 
Per admission 28-
days 
Censored at hospital 
discharge 
Primary  
Meam (SD) and Median with interquartile range 
 
 
ICU survival  
All patients/select subgroups 
Per admission  
Secondary  
Frequency with proportion of patients 
ICU Length of Stay  
All patients/select subgroups 
Per admission  
Secondary 
Median with interquartile range 
28-day hospital survival  
All patients/select subgroups 
28-days 
The first day of 
mechanical 
ventilation is day 0 
Censored at hospital 
discharge 
Secondary  
Frequency with proportion of patients 
Ventilator duration 
All patients/select subgroups 
Per admission  
Secondary  
Median with interquartile range 
Hospital survival  
All patients/select subgroups 
Per admission 
censored at 90 days 
after mechanical 
ventilation  
Secondary  
Frequency with proportion of patients 
Hospital Length of stay  
All patients/select subgroups 
Per admission  
censored at 90 days 
after mechanical 
ventilation 
Secondary 
Median with interquartile range 
Driving Pressure 
(Plateau pressure – PEEP) 
 
Patients ventilated with PF 
ratio ≤ 300 on controlled 
mode 
Throughout the ICU 
stay  
Secondary  
Median with interquartile range 
Mechanical Power 
(Mechanical power is calculated using the formula Power = 
0.098*respiratory rate•*(tidal volume/1000)*(Peak Pressure  – (0.5 • 
Driving Pressure) 
Patients ventilated with PF 
ratio ≤ 300 on controlled 
mode 
Throughout the ICU 
stay 
Secondary  
Median with interquartile range 
Utilization of veno-venous Extracorporeal Membrane Oxygenation (VV-
ECMO). 
 
 
 
 
All patients/select subgroups 
Per admission 
Secondary 
Frequency with proportion of patients 

Ethics ID: REB20-0646 
Study Title: TheraPPP 
PI: Dr. Ken Parhar 
V3/ Feb 14, 2023 
 
Implementation Outcomes - Fidelity 
Patient or subgroup 
Timepoints at 
which the 
outcomes are 
measured 
Primary or 
Secondary 
Outcome 
Reporting of results (unit of measurement) 
Fidelity Indicators 
 
 
 
 
Composite fidelity score  
The Composite Fidelity Score awards point for fidelity indicators 
. It can be interpreted as the average proportion of time pathway elements 
are appropriately performed, it: 
▪ 
Includes all mechanically ventilated patients  
▪ 
Is based on patients being eligible for up to four possible 
interventions per day and height ever documented during the 
ICU stay (specific indicators indicated by asterisk* below) 
▪ 
A day is only included if patient is eligible for that day 
▪ 
Height measurement only contributes 1 point to the score if it 
is ever measured during the ICU stay 
 
Patient subgroups for 
individual fidelity indicators are 
indicated by asterisk* in rows 
below 
Per admission 
(height) & daily (tidal 
volume, plateau 
pressure, 
neuromuscular 
blockade and 
proning) 
Primary  
 
For each patient, the composite fidelity score is 
calculated as: The number of times pathway 
elements were appropriately performed out of 
the number of times the patient was eligible for 
pathway elements throughout their ICU stay. 
 
The composite fidelity score is reported as 
Median (IQR) % and Mean (SD) % 
*Height ever documented 
Mechanically Ventilated 
patients  
Per admission 
Secondary 
Frequency with proportion of patients 
Height documented within 1 hour of admission to ICU 
Mechanically Ventilated 
patients 
Per admission 
Secondary  
Frequency with proportion of patients 
Height documented within 2 hours of admission to ICU 
Mechanically Ventilated 
patients 
Per admission 
Secondary  
Frequency with proportion of patients 
Time in minutes to height measurement from ICU admission (among 
patients with height ever documented) 
Mechanically Ventilated 
patients with a height 
measured  
Per admission 
Secondary 
Median with interquartile range  
*Tidal volume ≤ 8ml/kg PBW: Previously noted as Days of safe ventilation  
 
±If height is not documented, tidal volume indicator is determined based 
on using an average height of: 
- 
162cm for females [IBW 54.2kg, TV <=434ml] 
- 
176cm for males [IBW 71.5kg, TV <=572ml] 
Tidal volume set will be used for volume-controlled mode and tidal 
volume inhaled will be used for pressure-controlled mode. If inhaled or 
set tidal volume is not available, exhaled tidal volume is used. Indicator is 
based on the median daily tidal volume being ≤ 8 ml/kg PBW 
Patients ventilated: 
- ABG done that day between 
0000-0800 
- PF ratio ≤ 300 on that day  
- On controlled mode 
 
Daily  
Secondary 
Median (IQR) and mean (SD) proportion of 
eligible days 
Outcome is assessed daily, but then summarized 
as a proportion for each patient, and then the 
median or mean is taken 
*Plateau pressure measured   
*Patients ventilated  
- ABG done that day 
- PF ratio ≤ 300 on that day  
- On controlled mode 
Daily  
Secondary 
Median (IQR) and mean (SD) proportion of 
eligible days 
Outcome is assessed daily, but then summarized 
as a proportion for each patient, and then the 
median or mean is taken 

Ethics ID: REB20-0646 
Study Title: TheraPPP 
PI: Dr. Ken Parhar 
V3/ Feb 14, 2023 
 
*Receive neuromuscular blockade (NMB) in the consider group 
*Patients ventilated 
 - ABG done that day 
- PF ratio ≤ 150 on that day  
- On controlled mode 
 
Daily  
Secondary 
Median (IQR) and mean (SD) proportion of 
eligible days 
Outcome is assessed daily, but then summarized 
as a proportion for each patient, and then the 
median or mean is taken 
*Patient proned for those in the consider group  
*Patients ventilated  
- ABG done that day 
- PF ratio ≤ 150 and FiO2 ≥ 
0.60 on that day  
- On controlled mode 
- Not receiving ECLS that day  
Daily  
Secondary 
Median (IQR) and mean (SD) proportion of 
eligible days 
Outcome is assessed daily, but then summarized 
as a proportion for each patient, and then the 
median or mean is taken 
Implementation Outcomes - Acceptability 
Patient or subgroup 
Timepoints at 
which the 
outcomes are 
measured 
Primary or 
Secondary 
Outcome 
Reporting of results (unit of measurement) 
Pathway acceptability (Survey) 
 
 
 
 
Composite Acceptability Score: Summary of pathway acceptability 
measured using the 7 Theoretical Framework of Acceptability (TFA) 
component constructs (listed below†) 
Survey clinicians and pathway 
educators / champions 
Two to six months 
after implementation 
at each site  
Secondary 
Proportion of TFA component with median 
score 4 or 5 o a 5-point Likert scale, indicating 
agreement  
†Affective attitude (How an individual feels about the intervention) 
Survey clinicians and pathway 
educators / champions 
“ 
Secondary  
Median (IQR)  
†Burden (The perceived amount of effort that is required to participate 
in the intervention) 
Survey clinicians and pathway 
educators / champions 
“ 
Secondary  
Median (IQR)  
†Ethicality (The extent to which the intervention has a good fit with an 
individual’s value) 
Survey clinicians and pathway 
educators / champions 
“ 
Secondary 
Median (IQR)  
†Intervention coherence (The extent to which the participant 
understands the invention and how it works) 
Survey clinicians and pathway 
educators / champions 
“ 
Secondary 
Median (IQR)  
†Opportunity costs (The extent to which benefits, profits, or values 
must be given up to engage in the intervention 
Survey clinicians and pathway 
educators / champions 
“ 
Secondary 
Median (IQR)  
†Perceived effectiveness (The extent to which the intervention is 
perceived as likely to achieve its purpose) 
Survey clinicians and pathway 
educators / champions 
“ 
Secondary 
Median (IQR)  
†Self-efficacy (The participant’s confidence that they can perform the 
behavior(s) required to participate in the intervention) 
Survey clinicians and pathway 
educators / champions 
“ 
Secondary 
Median (IQR)  
 
 
 
 
 
 
 

Ethics ID: REB20-0646 
Study Title: TheraPPP 
PI: Dr. Ken Parhar 
V3/ Feb 14, 2023 
 
Effectiveness Outcomes - economic 
Patient or subgroup 
Timepoints at 
which the 
outcomes are 
measured 
Primary or 
Secondary 
Outcome 
Reporting of results (unit of measurement) 
Economic effectiveness outcomes  
 
 
 
 
Cost per ventilator free day  
All patients/subgroups 
Daily 
Primary  
Median (IQR) 
Total cost for the ICU admission 
All patients/subgroups 
Per admission 
Secondary 
Median (IQR) 
Total cost for the index hospitalization 
All patients/subgroups 
Per admission 
Secondary 
Median (IQR) 
ICU LOS (also noted as secondary clinical effectiveness outcome)  
All patients/subgroups 
Per admission  
Secondary 
Median (IQR) 
Hospital LOS also noted as secondary clinical effectiveness outcome) 
All patients/subgroups 
Per admission  
Secondary 
Median (IQR) 
Cost per quality adjusted life year (QALY) from the health care system 
perspective over the patient’s lifetime. 
All patients/subgroups 
Per admission 
Secondary 
Median (IQR) 
ABG=arterial blood gas. ECLS=extracorporeal life support. IBW=ideal body weight. ICU=intensive care unit. IQR=intraquartile range. LOS=length of stay. NMB=neuromuscular blockade. 
PEEP=positive end expiratory unit. PF ratio=PaO2/FiO2. TV=tidal volume. VFDs=ventilator free days.  
 

TheraPPP Protocol V 2.2
Feb 14, 2023
REB20-0646
1
Attachment 9. Acceptability survey 
Please take a few minutes to complete the following survey about your experience with the Venting 
Wisely Pathway.
Demographics (Q 1-5)
Please share a little information about yourself.
The following questions will help us tailor the Venting Wisely Pathway implementation and sustainment.
Space will be provided at the end of the survey for additional notes/comments.
1. What is your gender identity?
Man
Woman
Non-binary
Transgender
Two-Spirit
Prefer not to answer
Prefer to self-identify
REQUIREMENT: Request Response 
2. What is your age?
3. What is your primary role in the Intensive Care Unit? 
**Intensivist
**Critical Care Fellow 
** Resident
**Other Physician
Registered Nurse
Registered Respiratory therapist
Other clinician (Please specify, e.g. Physiotherapist, Occupational Therapist, Manager)
3a. What is your base specialty? 
BRANCHING LOGIC if ** above are checked 
4. The hospital / ICU I primarily work at is:
Chinook Regional Hospital Lethbridge
CVICU Calgary (at FMC)
CVICU (Mazankowski Heart Institute)
Foothills Medical Centre –  ICU
Grey Nuns Hospital
Medicine Hat Regional Hospital
Misericordia Community Hospital
Northern Lights Regional Health Centre
Peter Lougheed Centre
QE II – Grande Prairie Regional Hospital

TheraPPP Protocol V 2.2
Feb 14, 2023
REB20-0646
2
Red Deer Regional Hospital
Rockyview General Hospital
Royal Alexandra Hospital
South Health Campus
Sturgeon Community Hospital
University of Alberta Hospital – General Systems ICU
University of Alberta Hospital – Neuroscience ICU
5. How many years of experience do you have working in an Intensive Care Unit?
(Numerical response only)
Knowledge Assessment (Q 6-17)
The following 12 questions aid us in determining which aspects of education may require additional attention.
Space will be provided at the end of the survey for additional notes/comments.
6. It is essential for heights to be measured and documented on all mechanically ventilated patients.
True
False 
7. What information do you need to determine predicted body weight? (choose all that apply)
○
Weight
○
Sex  
○
Age    
○
Height    
8. In the Venting Wisely pathway, the arterial blood gas screening for hypoxemic respiratory failure (HRF) must be done:
(choose all that apply).
○
While the patient is 
at steady state    
○
Between 0000-0800   
○
Any time during the 
day or night 
○
When the patient is 
unstable
9. On an arterial blood gas that is obtained on a patient in a clinical steady state, what is the PF ratio threshold to be 
considered for the steps beyond height measurement in the Venting Wisely pathway?
○
Less than or equal 
to 100 
○
Less than or equal 
to 200
○
Less than or equal 
to 300 
○
Less than or equal 
to 400
10. Lung protective ventilation includes all of the following:
(Choose all that apply)
○
Calculating a predicted body 
weight 
○
Limiting tidal volumes
○
Limiting plateau pressure 
11. For patients with hypoxemic respiratory failure (HRF), when limiting tidal volume , what initial goal (mL/kg predicted 
body weight) should be targeted?
o
4-6
o
6-8
o
8-10
o
10-12

TheraPPP Protocol V 2.2
Feb 14, 2023
REB20-0646
3
12. For patients with hypoxemic respiratory failure (HRF), when limiting plateau pressure, an upper limit of how many 
cmH2O should be targeted?
o
Less than or equal 
to 25
o
Less than or equal 
to 30
o
Less than or equal 
to 35
o
Less than or equal 
to 40
13. To prevent inappropriately high tidal volumes in patients where the predicted body weight method is likely to 
overestimate lung size, such as in women or patients with short stature, driving pressure should be limited to: 
o
Less than or equal to 18
o
Less than or equal to 20
o
Less than or equal to 22
14. In the Venting Wisely pathway if a patient develops worsening hypoxemic respiratory failure (HRF) or does not meet 
lung protective ventilation goals, therapy will be escalated, beginning with neuromuscular blockade (paralysis). At what PF 
ratio should paralytics be considered?
o
Less than or equal 
to 100
o
Less than or equal 
to 150
o
Less than or equal 
to 200
o
Less than or equal 
to 300
15. In the Venting Wisely Pathway, neuromuscular blockade (paralytics) (choose all that apply)
o
May be PROPOSED by any 
member of the 
multidisciplinary team 
o
Need Most Responsible 
Health Practitioner 
APPROVAL prior to 
initiation 
o
Goals [eg. End-tidal CO2, Train of 
Four, ventilator dyssynchrony] should 
be determined by the Most 
Responsible Health Practitioner and 
documented in the Electronic Health
Record 
16. In the Venting Wisely pathway, a patient with a worsening PF ratio despite receiving lung protective ventilation and 
paralytics should be considered for prone positioning when they have: 
○
PF ratio less than or equal 
to 150
○
PF ratio less than or equal 
to 150 and FiO2 
requirement greater than 
or equal to 0.6
○
PF ratio less than or equal to 200 and 
FiO2 requirement greater than or 
equal to 0.6
17. According to the landmark PROSEVA trial, the minimal duration of prone positioning should be? 
o
Greater than or 
equal to 4 hours out 
of a 24 hour period 
o
Greater than or 
equal to 8 hours out 
of a 24 hour period
o
Greater than or 
equal to 16 hours 
out of a 24 hour 
period
o
Greater than or 
equal to 24 hours 
out of a 24 hour 
period
Acceptability Assessment (Q 18-24)
The following 7 questions focus on your perceptions about the pathway. For each question, please choose the response 
that fits best for you. 
Space will be provided at the end of the survey for additional notes/comments.

TheraPPP Protocol V 2.2
Feb 14, 2023
REB20-0646
4
18. How do you feel about the Venting Wisely pathway?
[Affective Attitude. How a clinician feels about the intervention] 
I feel extremely negative about the Venting Wisely pathway 
I feel negative about the Venting Wisely pathway 
I feel neither negative nor positive about the Venting Wisely pathway 
I feel positive about the Venting Wisely pathway 
I feel extremely positive about the Venting Wisely pathway 
19. How much time and effort are required to use the Venting Wisely pathway?
[Burden. Clinician’s perceived amount of effort required to participate in the pathway]
The Venting Wisely pathway takes a significant amount of extra time and effort compared to your prior standard of care 
The Venting Wisely pathway takes some extra time and effort compared to your prior standard of care 
The Venting Wisely pathway neither decreases nor increases the time or effort compared to your prior standard of care 
The Venting Wisely pathway takes reduced time and effort compared to your prior standard of care 
The Venting Wisely pathway takes a significantly reduced amount of time and effort compared to your prior standard of 
care 
20. Is the Venting Wisely pathway is in the patient and providers best interest?
[Ethicality: The extent to which the intervention has good fit with an individual’s value system]
I strongly believe that the Venting Wisely pathway is not in the patient and providers best interest 
I believe that the Venting Wisely pathway is not in the patients and providers best interest  
The Venting Wisely pathway is neither against nor for the patient and providers best interest  
I believe that the Venting Wisely pathway is in the patient and providers best interest  
I strongly believe that the Venting Wisely pathway is in the patient and providers best interest  
21. What is your level of understanding of the Venting Wisely pathway elements and how the pathway
works?
[Intervention coherence]: the extent to which the clinician understands the intervention] 
I have an extremely limited understanding of the Venting Wisely pathway  
I have a limited understanding of the Venting Wisely pathway 
I have neither a limited nor comprehensive understanding of the Venting Wisely pathway 
I have a comprehensive understanding of the Venting Wisely pathway 
I have an extremely comprehensive understanding of the Venting Wisely pathway  
22. What was it like to balance the Venting Wisely pathway with all of the other daily tasks for your
patients?
[Opportunity costs: benefits or costs to the clinician for using the pathway] 
The Venting Wisely pathway made it significantly more difficult to balance all of the other daily tasks for my patients 
The Venting Wisely pathway made it more difficult to balance all of the other daily tasks for my patients 
The Venting Wisely pathway made no difference in balancing all of the other daily tasks for my patients 

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The Venting Wisely pathway made it easier to balance all of the other daily tasks for my patients
The Venting Wisely pathway made it significantly easier to balance all of the other daily tasks for my patients
23. How likely is the Venting Wisely pathway to impact the use of evidence-based care?
[Perceived effectiveness. the extent to which the intervention is perceived by clinicians as likely to achieve its purpose]
The Venting Wisely pathway is extremely unlikely to impact the use of evidence-based care 
The Venting Wisely pathway is unlikely to impact the use of evidence-based care 
The Venting Wisely pathway is neither unlikely nor likely to impact the use of evidence-based care 
The Venting Wisely pathway is likely to impact the use of evidence-based care and patient
The Venting Wisely pathway is extremely likely to impact the use of evidence-based care
24. What is your confidence level that you can perform all of the elements of the Venting Wisely 
pathway associated with your discipline?
[self-efficacy: clinician’s confidence that they can use the pathway]
I strongly lack confidence that I can perform all of the elements of the Venting Wisely pathway associated with my
discipline
I somewhat lack confidence that I can perform all of the elements of the Venting Wisely pathway associated with my
discipline
I neither lack nor have confidence that I can perform all of the elements of the Venting Wisely pathway associated with my
discipline
I am somewhat confident that I can perform all of the elements of the Venting Wisely pathway associated with my
discipline
I am extremely confident that I can perform all of the elements of the Venting Wisely pathway associated with my
discipline
Enablers (Q 25-34)
The following 9 questions focus on the tools we used to bring Venting Wisely into your Intensive Care Unit.
During implementation of the Venting Wisely, several strategies were used to help promote its use. We are interested 
in which strategies you recognize as having used to encourage pathway uptake and how helpful you felt they 
were.
For each strategy listed below, please select those that you RECALL having seen, received, or participated in, 
If you RECALL the strategy, you will be asked to RATE how helpful you felt they were in encouraging uptake of 
the Venting Wisely pathway.
Q25. I RECALL the Venting Wisely Grand Rounds presentation by Dr. Ken Parhar
Yes 
No 
REQUIREMENT: Request Response

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Q25a. Please RATE how helpful Grand Rounds was in encouraging uptake of the Venting Wisely pathway.
Not at all helpful
Slightly helpful 
Somewhat helpful
Very helpful 
Extremely helpful
BRANCHING LOGIC if 25 is checked: yes. 
REQUIREMENT: Request Response
Q26. I RECALL participating in virtual and / or in-person Venting Wisely education sessions. Yes
No
REQUIREMENT: Request Response
Q26a. The education session I participated in was facilitated by: 
(choose all that apply):
An educator on my unit
A Venting Wisely Practice Lead
Other (please specify)
BRANCHING LOGIC if 25 is checked: yes. 
REQUIREMENT: Request Response
________________________
26b. Please RATE how helpful the education session was in encouraging uptake of the Venting Wisely pathway.
Not at all helpful
Slightly helpful 
Somewhat helpful
Very helpful 
Extremely helpful
BRANCHING LOGIC if 26 is checked: yes. 
REQUIREMENT: Request Response
27. I RECALL watching the Venting Wisely instructional videos.
Yes
No
REQUIREMENT: Request Response
27a. Please RATE how helpful the Venting Wisely instructional videos were in encouraging uptake of the Venting 
Wisely pathway.
Wisely pathway.
Not at all helpful
Slightly helpful 
Somewhat helpful
Very helpful 
Extremely helpful
BRANCHING LOGIC if 27 is checked: yes. 
REQUIREMENT: Request Response

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28. I RECALL the Venting Wisely pathway diagram.
(see below)
Yes
No
REQUIREMENT: Request Response
28a. Please RATE how helpful the Venting Wisely pathway diagram was in encouraging uptake of the Venting 
Wisely pathway.
Wisely pathway.
Not at all helpful
Slightly helpful 
Somewhat helpful
Very helpful 
Extremely helpful
BRANCHING LOGIC if 28 is checked: yes. 
REQUIREMENT: Request Response
29. I RECALL the Venting Wisely pocket cards. 
(see below)

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Yes
No
REQUIREMENT: Request Response
29a. Please RATE how helpful the Venting Wisely pocket card was in encouraging uptake of the Venting Wisely pathway.
Wisely pathway.
Not at all helpful
Slightly helpful 
Somewhat helpful
Very helpful 
Extremely helpful
BRANCHING LOGIC if 29 is checked: yes. 
REQUIREMENT: Request Response
30. I RECALL the Venting Wisely electronic form for Registered Respiratory Therapists in MetaVision or Connect Care.
(see below)

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Yes
No
REQUIREMENT: Request Response
30a. Please RATE how helpful the Venting Wisely electronic form for Registered Respiratory Therapists was in 
encouraging uptake of the Venting Wisely pathway.
Wisely pathway.
Not at all helpful
Slightly helpful 
Somewhat helpful
Very helpful 
Extremely helpful
BRANCHING LOGIC if 30 is checked: yes. 
REQUIREMENT: Request Response
31 I RECALL the Venting Wisely practice guideline
(see below) 
Yes
No
REQUIREMENT: Request Response

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31. Please RATE how helpful the Venting Wisely practice guideline was in encouraging uptake of the Venting 
Wisely pathway.
Wisely pathway.
Not at all helpful
Slightly helpful 
Somewhat helpful
Very helpful 
Extremely helpful
BRANCHING LOGIC if 31 is checked: yes. 
REQUIREMENT: Request Response
32. I RECALL receiving Venting Wisely audit and feedback pathway adherence rates.
(see below)
Yes
No
REQUIREMENT: Request Response
32a. The Venting Wisely audit and feedback that I RECALL was:
(choose all that apply)
In a poster on my unit
In an email 
In a meeting (e.g. at a unit meeting or an audit and feedback meeting)
Other (please specify) _______________
Not sure where I saw it
BRANCHING LOGIC if 32 is checked: yes. 
REQUIREMENT: Request Response
32b. Please RATE how helpful the Venting Wisely audit and feedback was in encouraging uptake of the Venting 
Wisely pathway.
Wisely pathway.
Not at all helpful
Slightly helpful 
Somewhat helpful
Very helpful 
Extremely helpful
BRANCHING LOGIC if 32 is checked: yes. 

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REQUIREMENT: Request Response
33. I RECALL receiving support to use the Venting Wisely pathway, for example verbal or email reminders, support from 
educators or Practice Leads. 
Yes
No
REQUIREMENT: Request Response
33a. The support I received to help use the Venting Wisely pathway was:
(check all that apply)
Verbal reminders or coaching from educators
Email or website reminders 
Knowledge Translation Practice Lead support
A local clinical leader championing the pathway
A Quality Improvement team member 
Other (please specify) 
BRANCHING LOGIC if 33 is checked: yes. 
REQUIREMENT: Request Response
33b. Please RATE how helpful the Venting Wisely above help was in encouraging uptake of the Venting Wisely pathway.
Wisely pathway.
Not at all helpful
Slightly helpful 
Somewhat helpful
Very helpful 
Extremely helpful
BRANCHING LOGIC if 33 is checked: yes. 
REQUIREMENT: Request Response
36. Do you have any comments or suggestions about the Venting Wisely Pathway?
Thank you for participating! If you have any questions please contact Dr. Ken Parhar 
ken.parhar@albertahealthservices.ca

 
 
 
TheraPPP Protocol V 2.1 
February 14, 2023 
REB20-0646 
 
Attachment 10. Interview Guide for Clinician Focus Groups 
 
 
 
 
 
Briefing (5 minutes) 
1. Welcome and thank you for agreeing to take part in this focus group 
discussion about the Venting Wisely pathway. 
2. [Introduce self] 
3. As described in our email, we are interested in hearing about your 
perceptions of the Venting Wisely pathway as well as feedback on what can 
be done to improve and sustain its implementation. 
4. We emailed you a copy of the informed consent form. The consent 
form is part of the process of informed consent. It should give you a 
basic idea of what the research is about and what your 
participation will involve. Did everyone receive the consent form and have a 
chance to read through it Good. Because it is important that you understand your 
rights as a participant, I just want to review the main elements in the consent 
form: 
[Interviewer will read the REB approved Oral Consent Script] 
5. All information I collect is confidential. I hope this encourages you to speak 
freely. We would like the discussion to be informal, so there’s no need to wait 
for us to call on you to respond. In fact, we encourage you to respond directly 
to the comments other people make. If you don’t understand a question, 
please let us know. We are here to ask questions, listen, and make sure 
everyone has a chance to share. 
6. Does anyone object to me recording our conversation? The recording will be 
typed out, but everything you say will be anonymous. 
[Press record] 
Ground rules 
• 
The most important rule is that only one person speaks at a time. 
• 
There are no right or wrong answers 
• 
You do not have to speak in any particular order 
• 
You do not have to agree with the views of other people in the group 
• 
Does anyone have any questions? (answers). 
• 
Ok let’s begin: 
You have been asked to participate in this study because you work in an ICU where the Venting 
Wisely pathway was implemented. Briefly, this was an evidence-based, stakeholder-informed 
pathway for the diagnosis and management of hypoxemic respiratory failure. This pathway 
included six steps: 1) Measure: where all mechanically ventilated patients had their height and 
predicted body weight measured and recorded; 2) Screen: Where patients were screened for the 
presence of HRF using PF ratios. 3) Manage: Lung Protective Ventilation was initiated for 
patients with HRF; 4) Monitor: plateau pressure & driving pressure, optimal PEEP study; 5) 
Paralysis: if the patient develops worsening HRF and does not meet LPV goals, therapy was 
escalated using a neuromuscular blockade. Patients with worsening PF ratio despite steps 1-4 will 
be considered for prone positioning followed by proning, followed by ECLS. 
Warm up 

 
 
 
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February 14, 2023 
REB20-0646 
 
I’d like everyone to introduce themselves. Please tell us your name and a sentence or two 
about the background that brings you here 
Question 
Probe 
Notes 
1. I’m going to give you a 
minute to think about your 
experience as a clinician 
using the Venting Wisely 
(VW) pathway: How do 
you feel about the Venting 
Wisely pathway? 
Affective Attitude: How an 
individual feels about an 
intervention 
What did you like about it? 
(Ask about implementation or 
the pathway itself) 
What did you dislike about it? 
(Ask about implementation or 
the pathway itself) 
 
2. How do you think using 
the Venting Wisely 
pathway will impact the 
use of evidence-based 
care and improve patient 
outcomes? 
Perceived effectiveness: The 
extent to which the 
intervention is perceived as 
likely to achieve its purpose 
If yes, what do you think some 
of the benefits of the VW are? 
 
If not, is this due to a problem 
with implementation of the 
pathway on your unit? Or with 
the pathway itself? (maybe 
ask more neutral as this is 
leading: could just ask why 
and ask probing questions to 
understand) 
 
3. How did the Venting 
Wisely pathway change 
your confidence in caring 
for HRF / ARDS 
patients? 
Self-efficacy: The participant’s 
confidence that they can 
perform the behaviour(s) 
required to participant in the 
intervention 
 
What’s your confidence level 
that you can perform all of the 
Venting Wisely pathway 
therapies associated with your 
discipline?  
What kind of support was 
helpful in gaining confidence?  
• 
Implementation support 
(e.g. education at Grand 
Rounds)?  
• 
Experience with the 
pathway post 
implementation?  
Is there something that could 
have supported you in gaining 
confidence?  
• 
During implementation? 
 

 
 
 
TheraPPP Protocol V 2.1 
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REB20-0646 
 
Within the pathway itself? 
4. 
How much time or effort was 
it to use the Venting Wisely 
pathway? 
Burden: The perceived 
amount of effort that is 
required to participate in the 
intervention 
If a lot, ask about 
implementation or the use of 
the pathway itself.  
If not much, did it make your 
day more efficient?  
 
5. What is your 
understanding of the goal 
of the Venting Wisely 
pathway and how it 
works? 
Intervention coherence: The 
extent to which the participant 
understands the intervention 
and how it works  
What was (or would be) most 
helpful ( for you to understand 
the goals of VW and how to 
perform the pathway?  
 
 
6. What was it like to 
balance the Venting 
Wisely pathway with all 
the other daily tasks for 
your patients?  
Opportunity costs: The extent 
to which benefits, profits, or 
values must be given up to 
engage in the intervention  
Were there patient care tasks 
you felt you had to give up, or 
do more quickly, to incorporate 
VW pathway therapies? 
 
If yes, what part of the 
pathway took too much time 
and what did you end up 
giving up (pathway or other)? 
 
7. Do you think the 
Venting Wisely 
pathway is in the 
best interest of 
patient? What about 
the best interests of 
the provider? 
Ethicality: The extent to which 
the intervention has good fit 
with an individual’s value 
system 
Which parts are in the best 
interests of patient or 
provider? 
Which parts are NOT in the 
best interests of patient or 
provider? 
 
 
8. Our aim is that VW 
becomes part of daily 
clinical practice. What 
could help this sustained 
once the project team is 
no longer available?  
Which elements of the path 
will be most difficult to 
sustain?  
 
 

 
 
 
TheraPPP Protocol V 2.1 
February 14, 2023 
REB20-0646 
 
Optional, time permitting: 
What did your unit do really 
well in adopting Venting 
Wisely?  
Why do you think you were so 
successful?  
 
 
Is there anything else you would 
like to share with us? 
If no one answers, go around and 
ask what is one thing you would 
like to tell the study team about 
the Venting Wisely pathway? 
 
Do you have any questions for 
us? 
 
 
 
Summary (depending on time) 
 
Do you have any questions for us? 
 
Thank you for sharing your time and personal experience! 
 
 

20-0626 
Feb 14, 2023  
v1.0 
Attachment 11. Ethics Modifications  
 
Modification 1 (protocol version 1.0 to 2.0 December 9, 2020) 
(1) Update Principal Investigator’s email address on the protocol  
 
(2) Add EPIC Connect Care  
Alberta Health Services is launching a new electronic clinical information system: EPIC Connect Care. 
Connect care Implementation began in 2019 and roll out will continue in a sequence of nine waves, 
completing in 2023. To collect data for the above study we will need to access EPIC Connect Care. No 
additional data metrics will be collected.  
 
(3) Add new funding source  
In October 2020, Dr. Parhar was successful in securing Health Innovation and Implementation Spread 
(HIIS) Funding (Alberta Health Services). This funding will ensure Knowledge Translation of the 
TheraPPP Study (REB20-0646). The funds will become available in January 2020.  
Modification 2 (protocol version 2.0 to 2.1 February 23, 2022) 
We are submitting this ethics modification to request direct access to manually collect data from paper charts to 
acquire missing data for patients cared for in non-traditional ICU settings (Coronary Care Unit, Post-operative care 
unit) due to Covid surges.  
We are also providing updates on:  
(1) Minor updates  as a result of the completion of the Statistical Analysis Plan by the Scientific Steering 
Group: 
i. 
Details added to outcomes  
ii. 
Duration of follow up period increased from two to four months to ensure a sufficient number of 
patients with sustained ARDS  
 
 
(2) Updates to the implementation strategy based on our finalized analysis of barriers to Venting Wisely 
implementation.  
 
(3) Minor changes to focus groups (finalized as we will conduct soon)  
i. 
Interview guide   
ii. 
Invitation  
iii. 
Group make up (4 to 8 single discipline, eg. RN, RT, MD, per focus group = 50 to 100 total 
participants) 
iv. 
Informed consents (full consent to be emailed before the focus group, oral consent will be obtained 
at the focus group)  
v. 
Add Rev.com listed as the transcription service we will use  
vi. 
Add Zoom as the way focus groups will be conducted and add Zoom recording to audiotaping of the 
focus groups  
vii. 
Demographic sheet added  
viii. 
Branding added  
 
(4) Updates to acceptability survey (finalized as we will conduct soon)  
i. 
Timing of acceptability survey  
ii. 
Survey questions   
iii. 
Branding added to invitation letter  
iv. 
Informed consent updated with the name of the pathway (Venting Wisely) 
v. 
One survey to be administered to RN, MD and RT (not a different survey for RNs)  
vi. 
Change in estimate for surveys (625 responses are a conservative estimate, we may receive up to 
1000) 
 
(5) Updates to site resources and protocol with Venting Wisely pathway branding 

20-0626 
Feb 14, 2023  
v1.0 
 
(6) Update Principal Investigator’s title 
Modification 3 – No protocol amendment  
To ensure completion of the demographics survey for the focus groups and to preserve the confidentiality of the 
participants, we will be using Qualtrics to collect focus group participant demographic information. A discussion 
of the use of Qualtrics to collect demographic data was added to the Focus Group consents (consent and oral 
consent). 
Modification 4 (protocol version 2.1 to 2.2 June 13, 2022)We are submitting this ethics modification to 
request permission to provide a $50 gift card to clinicians who participate in a focus group to thank them for their 
time. For the past six weeks have been recruiting clinicians for our first six focus groups. The response rate has 
been less than 30%. We hope that the cash incentive will boost recruitment and allow us to conduct focus groups.  
 
 
Modification 5 (protocol version 2.2 to 2.3 September 2, 2022) 
To the TheraPPP protocol: 
(1) Clarified that sampling in the focus group would be homologous by discipline 
(2) Increased the total number of focus groups from 8-12 to "up to 17" in the protocol  
(3) Changed the wording from "a total of 32-96" to "approximately 100" participants 
 
To the consent form: 
(1) Added details about how the gift card would be provided  
 
To both the consent form and the protocol: 
(1) Added the clinician discipline: "Nurse Practitioner" 
 
Modification 6 (protocol version 2.3 to 2.4 October 28, 2022) 
We are submitting this ethics modification to: 
(1) Request permission to provide one $200 gift card to the unit manager of any of our ICU sites who 
complete at least 30 acceptability surveys to thank units for their time. In other studies, we have 
experienced challenges recruiting ICU staff for surveys since Covid-19. We experienced similar challenges 
recruiting clinicians to this studies’ focus groups until we offered a small incentive.  
(2) Detail how we will store emails that we use to send the survey.  
(3) Update our survey before we send it.  
Modification 7 (protocol version 2.4 to 2.5 February 14, 2023) 
 
Editorial updates, added a summary of protocol amendments table. Clarified that the ventilator duration, which is a 
component of VFDs, will be reported as a secondary outcome.  

Ethics ID: 20-0646 
Study Title: Identification and Treatment of Hypoxemic Respiratory Failure (HRF) and ARDS with 
Protection, Paralysis, and Proning: TheraPPP (Venting Wisely Acceptability Survey) 
PI: Dr. Ken Parhar 
 
Version 2.1 
October 28, 2022 
Page 1 of 3 
 
 
 
 
 
 
TITLE:  
Identification and Treatment of Hypoxemic Respiratory Failure 
(HRF) and ARDS with Protection, Paralysis, and Proning: 
TheraPPP (Acceptability Survey – Venting Wisely pathway)  
 
INVESTIGATORS: 
Dr. Ken Parhar (PI) 
 
SPONSOR:  
 
Dr. Tom Stelfox (Department of Critical Care Medicine) 
 
 
 
Canadian Institutes of Health Research (CIHR) 
 
This information sheet is only part of the process of informed consent. It should give you the 
basic idea of what the research is about and what your participation will involve. If you would 
like more detail about something mentioned here, or information not included here, please ask. 
Take the time to read this carefully and to understand any accompanying information.  
 
BACKGROUND 
 
Acute hypoxemic respiratory failure (HRF) is common within the Intensive Care Unit (ICU). A 
significant proportion of these patients develop Acute Respiratory Distress Syndrome (ARDS), 
which is associated with a mortality of 40-60% in severe cases. Three interventions have been 
shown to improve the survival of patients with ARDS: Lung Protective Ventilation (LPV), 
neuromuscular blockade (paralysis), and prone positioning. The lack of a standardized approach 
outlining the management of ARDS patients has resulted in significant variability in the 
application of these interventions. Moreover, evidence suggests that the rational and 
algorithmic/pathway approach to the application of these interventions is associated with 
improved outcomes. 
 
To bridge the gap between research and patient care, and deliver lifesaving therapies for HRF 
patients in a fair and rational way, the Department of Critical Care Medicine (DCCM) is 
implementing an evidence-based, stakeholder-informed care pathway (Venting Wisely). The 
pathway was developed using a consensus process and relevant literature findings, and was 
validated by a broad group of stakeholders across Alberta. The Venting Wisely pathway 
standardizes the diagnosis and management of patients with HRF with the goal of reducing 
practice variation and improving adherence to evidence-informed therapy.  
 
WHAT IS THE PURPOSE OF THE STUDY? 
 
The purpose of this study is to evaluate the Venting Wisely pathway. The specific purpose of this 
survey is to evaluate clinician knowledge and perceptions about the acceptability of the Venting 
Wisely pathway following implementation.  
 

Ethics ID: 20-0646 
Study Title: Identification and Treatment of Hypoxemic Respiratory Failure (HRF) and ARDS with 
Protection, Paralysis, and Proning: TheraPPP (Venting Wisely Acceptability Survey) 
PI: Dr. Ken Parhar 
 
Version 2.1 
October 28, 2022 
Page 2 of 3 
WHAT WOULD I HAVE TO DO? 
 
You are being asked to take part in a survey to evaluate knowledge about and  acceptability of 
the implementation of the Venting Wisely pathway. Because you are an ICU clinician who used 
the pathway, your knowledge and feedback about pathway implementation is very important. 
Should you agree to participate, you will complete a short survey (15 minutes) to assess 
knowledge and acceptability of the pathway.  
 
WHAT ARE THE RISKS? 
 
There are no foreseen risks to participating in this study.  You will not be asked to provide any 
identifying data.  All responses will be kept anonymous.  Data will be presented in aggregate. 
 
WILL I BENEFIT IF I TAKE PART? 
 
If you agree to participate in this study, there may or may not be a direct benefit to you. The 
information we gain from this process will be used to inform the full implementation of the 
pathway. The information you provide will also help with the design of other quality 
improvement initiatives. It is anticipated the results of this study will be shared with others in the 
following ways: medical journal articles, medical conferences, and summary report sheets for 
participants. 
 
DO I HAVE TO PARTICIPATE? 
 
Participation in this study is voluntary. If you decide to take part, your consent to participate will 
be implied. You may decline to take part in this study, or at any time during the study you may 
decide to stop your participation without penalty. Once the survey is submitted, it will be 
impossible to isolate individual participants which limits data withdrawal from the study at that 
point.  
 
You will be advised in a timely manner of any new information that becomes available that may 
affect your willingness to remain in the study. 
 
WILL I BE PAID FOR PARTICIPATING, OR DO I HAVE TO PAY FOR ANYTHING? 
 
To thank you for completing the survey and to encourage participation, if your intensive care 
unit completes at least 30 surveys, we will provide a $200 gift card to your manager for your 
unit.  
. 
 
WILL MY RECORDS BE KEPT PRIVATE? 
 
Your privacy is important to us. The information collected will be stored and maintained 
confidentially and destroyed as required by law. Your name and personal information will not be 
made available to anyone who is not involved in this study unless disclosure is required by law. 

Ethics ID: 20-0646 
Study Title: Identification and Treatment of Hypoxemic Respiratory Failure (HRF) and ARDS with 
Protection, Paralysis, and Proning: TheraPPP (Venting Wisely Acceptability Survey) 
PI: Dr. Ken Parhar 
 
Version 2.1 
October 28, 2022 
Page 3 of 3 
The results of this study will be published in a medical literature, but your personal information 
will not be revealed.  
 
AGREEMENT TO PARTICIPATE 
 
Your decision to complete this survey will be interpreted as an indication of your agreement to 
participate. In no way does this waive your legal rights nor release the investigators, or involved 
institutions from their legal and professional responsibilities. You are free to withdraw from the 
study at any time. 
 
If you have further questions concerning matters related to this research, please contact: 
 
Gwen Knight, Research Associate (403) 944-0735 
Or  
Dr. Ken Parhar (403) 944-0735 
 
If you have any questions concerning your rights as a possible participant in this research, please 
contact the Chair of the Conjoint Health Research Ethics Board, Research Services, University 
of Calgary, 403-220-7990. 
 
 
The University of Calgary Conjoint Health Research Ethics Board has approved this research 
study. 
 

 
Ethics ID: 20-0646 
Study Title: Identification and Treatment of Hypoxemic Respiratory Failure (HRF) and ARDS with 
Protection, Paralysis, and Proning: TheraPPP (Focus Group – Venting Wisely pathway) 
PI: Dr. Ken Parhar 
 
Version 2.4 
Sep 2, 2022 
Page 1 of 4 
 
 
 
 
 
 
TITLE:  
Identification and Treatment of Hypoxemic Respiratory Failure 
(HRF) and ARDS with Protection, Paralysis, and Proning: 
TheraPPP (Focus Group – Venting Wisely pathway)  
 
INVESTIGATORS: 
Dr. Ken Parhar (PI) 
 
SPONSOR:  
 
Dr. Tom Stelfox (Department of Critical Care Medicine) 
 
 
 
Canadian Institutes of Health Research (CIHR) 
 
This information sheet is only part of the process of informed consent. It should give you the 
basic idea of what the research is about and what your participation will involve. If you would 
like more detail about something mentioned here, or information not included here, please ask. 
Take the time to read this carefully and to understand any accompanying information.  
 
BACKGROUND 
 
Acute hypoxemic respiratory failure (HRF) is common within the Intensive Care Unit (ICU). A 
significant proportion of these patients develop Acute Respiratory Distress Syndrome (ARDS), 
which is associated with a mortality of 40-60% in severe cases. Three interventions have been 
shown to improve the survival of patients with ARDS: Lung Protective Ventilation (LPV), 
neuromuscular blockade (paralysis), and prone positioning. The lack of a standardized approach 
outlining the management of ARDS patients has resulted in significant variability in the 
application of these interventions. Moreover, evidence suggests that the rational and 
algorithmic/pathway approach to the application of these interventions is associated with 
improved outcomes. 
 
To bridge the gap between research and patient care, and deliver lifesaving therapies for HRF 
patients in a fair and rational way, the Department of Critical Care Medicine (DCCM) is 
implementing an evidence-based, stakeholder-informed care pathway (Venting Wisely pathway). 
The pathway was developed using a consensus process and relevant literature findings, and was 
validated by a broad group of stakeholders across Alberta. Venting Wisely standardizes the 
diagnosis and management of patients with HRF with the goal of reducing practice variation and 
improving adherence to evidence-informed therapy.  
 
WHAT IS THE PURPOSE OF THE STUDY? 
 

 
Ethics ID: 20-0646 
Study Title: Identification and Treatment of Hypoxemic Respiratory Failure (HRF) and ARDS with 
Protection, Paralysis, and Proning: TheraPPP (Focus Group – Venting Wisely pathway) 
PI: Dr. Ken Parhar 
 
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Sep 2, 2022 
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The purpose of this study is to evaluate effectiveness and acceptability of the Venting Wisely 
pathway. The specific purpose of this focus group is to evaluate clinician perceptions about the 
acceptability of the Venting Wisely pathway following implementation.  
 
WHAT WOULD I HAVE TO DO? 
 
You are being asked to take part in a focus group to evaluate the acceptability of the Venting 
Wisely implementation. Because you are an ICU clinician who used the pathway, your feedback 
and input to pathway implementation is very important.   
 
If you volunteer to participate in this study, the researcher will ask you to do the following: 
• Complete a short demographic questionnaire in Qualtrics, an online survey platform, 
about you, your professional role, and hospital you work in. 
• Join the focus group through your computer using the Zoom Videoconferencing platform 
(https://zoom.us) links provided to you by our research team. The focus group facilitator 
will provide you all the details you need to join the call prior to your focus group date.  
• Participate in a discussion on the acceptability of the Venting Wisely pathway. 
• Agree to have the study team record the audio of the focus group discussion.  It is 
important to record the discussion so we can accurately document what it said. 
• Once the interview is over, a member of the study team will send you a summary of the 
interview for you to review and provide feedback, should you want. The summary will be 
deidentified of participant personal information. 
 
HOW LONG WILL I BE IN THE STUDY? 
 
Your participation in this study will take about 1.5 -2 hours. 
 
WHO ELSE WILL BE IN THE STUDY? 
 
In each focus group, there will be up to  to eight intensive care unit clinicians (Nurse 
Practitioners, Registered Respiratory Therapists, Registered Nurses, or physicians). Focus groups 
will include only one professional designation which means they will consist of only Nurse 
Practitioners, Registered Respiratory Therapists, or only Registered Nurses, or only physicians.  
 
WHAT ARE THE RISKS? 
 
There are no foreseen risks to participating in this study.  You will not be asked to provide any 
identifying data.  All responses will be kept anonymous. Your confidentiality cannot be 
guaranteed as participants may not hold material confidential. Data will be presented in 
aggregate. 
 
WILL I BENEFIT IF I TAKE PART? 
 

 
Ethics ID: 20-0646 
Study Title: Identification and Treatment of Hypoxemic Respiratory Failure (HRF) and ARDS with 
Protection, Paralysis, and Proning: TheraPPP (Focus Group – Venting Wisely pathway) 
PI: Dr. Ken Parhar 
 
Version 2.4 
Sep 2, 2022 
Page 3 of 4 
If you agree to participate in this study, there may or may not be a direct benefit to you. The 
information we gain from this process will be used to inform the full implementation of the 
pathway. The information you provide will also help with the design of other quality 
improvement initiatives. It is anticipated the results of this study will be shared with others in the 
following ways: medical journal articles, medical conferences, and summary report sheets for 
participants. 
 
DO I HAVE TO PARTICIPATE? 
 
Participation in this study is voluntary. If you decide to take part, your consent to participate will 
be implied. You may decline to take part in this study, or at any time during the study you may 
decide to stop your participation without penalty. Once the audio recordings are transcribed it 
will be impossible to isolate individual participants which limits data withdrawal from the study 
at that point. 
 
You will be advised in a timely manner of any new information that becomes available that may 
affect your willingness to remain in the study. 
 
WILL I BE PAID FOR PARTICIPATING, OR DO I HAVE TO PAY FOR ANYTHING? 
 
To compensate your time, you will receive a $50 gift card for participating in this research study. 
After the focus group the facilitator will email participants a $50 "University of Calgary 
EverythingCard" redemption code. EverythingCard is Canada’s most widely used gift card 
platform to simplify delivery of gift cards. The University of Calgary is using EverythingCard to 
allow researchers to purchase online codes for subject fees to be distributed to their research 
subjects as a token of appreciation for their time and effort in participating in a study. The 
EverythingCard platform allows participants to redeem their codes online and select their own 
gift card(s) from a variety of retailers. 
 
 
WILL MY RECORDS BE KEPT PRIVATE? 
 
Your privacy is important to us. The information collected will be stored and maintained 
confidentially and destroyed as required by law. Your name and personal information will not be 
made available to anyone who is not involved in this study unless disclosure is required by law. 
The results of this study will be published in a medical literature, but your personal information 
will not be revealed.  
 
Your demographic data will be collected in Qualtrics an online survey platform with servers 
located in Toronto, Ontario, Canada. All data are encrypted and stored directly on its servers. 
Researcher access to the survey data is password-protected and the transmission is encrypted. IP 
tracking will be off. Survey responses cannot be linked to your computer. All information will be 
stored in a secured area (i.e. locked filing cabinet and/or password protected computer). 
 

 
Ethics ID: 20-0646 
Study Title: Identification and Treatment of Hypoxemic Respiratory Failure (HRF) and ARDS with 
Protection, Paralysis, and Proning: TheraPPP (Focus Group – Venting Wisely pathway) 
PI: Dr. Ken Parhar 
 
Version 2.4 
Sep 2, 2022 
Page 4 of 4 
A third-party transcription service, Rev.com, will be used to transcribe the focus group 
interviews. Rev.com is an online transcription service that follows best practices handling 
personally identifiable information with guidance from the published General Data Protection 
Regulation. Information regarding their privacy policy can be found 
at https://www.rev.com/about/privacy. 
 
AGREEMENT TO PARTICIPATE 
 
Your participation in the focus group will be interpreted as explicit oral consent of your 
agreement to participate. In no way does this waive your legal rights nor release the 
investigators, or involved institutions from their legal and professional responsibilities. You are 
free to withdraw from the study at any time. 
 
If you have further questions concerning matters related to this research, please contact: 
 
Gwen Knight, Research Associate (403) 944-0735 
Or  
Dr. Ken Parhar (403) 944-0735 
 
If you have any questions concerning your rights as a possible participant in this research, please 
contact the Chair of the Conjoint Health Research Ethics Board, Research Services, University 
of Calgary, 403-220-7990. 
 
The University of Calgary Conjoint Health Research Ethics Board has approved this research 
study.