Impact of restricted family presence during the COVID-19 pandemic on critically ill patients, families, and critical care clinicians: a qualitative systematic review.

BACKGROUND: We aimed to synthesize the qualitative evidence on the impacts of COVID-19-related restricted family presence policies from the perspective of patients, families, and healthcare professionals from neonatal (NICU), pediatric (PICU), or adult ICUs. METHODS: We searched MEDLINE, EMBASE, Cochrane Databases of Reviews and Clinical Trials, CINAHL, Scopus, PsycINFO, and Web of Science. Two researchers independently reviewed titles/abstracts and full-text articles for inclusion. Thematic analysis was completed following appraising article quality and assessing confidence in the individual review findings using standardized tools. RESULTS: We synthesized 54 findings from 184 studies, revealing the impacts of these policies in children and adults on: (1) Family integrated care and patient and family-centered care (e.g., disruption to breastfeeding/kangaroo care, dehumanizing of patients); (2) Patients, families, and healthcare professionals (e.g., negative mental health consequences, moral distress); (3) Support systems (e.g., loss of support from friends/families); and (4) Relationships (e.g., loss of essential bonding with infant, struggle to develop trust). Strategies to mitigate these impacts are reported. CONCLUSION: This review highlights the multifaceted impacts of restricted visitation policies across distinct care settings and strategies to mitigate the harmful effects of these policies and guide the creation of compassionate family presence policies in future health crises. REGISTRATION: https://www.crd.york.ac.uk/PROSPERO/display_record.php?RecordID=290263 .

Awake proning in patients with COVID-19-related hypoxemic acute respiratory failure: A rapid practice guideline.

This rapid practice guideline provides evidence-based recommendations for the use of awake proning in adult patients with acute hypoxemic respiratory failure due to COVID-19. The panel included 20 experts from 12 countries, including one patient representative, and used a strict conflict of interest policy for potential financial and intellectual conflicts of interest. Methodological support was provided by the guidelines in intensive care, development, and evaluation (GUIDE) group. Based on an updated systematic review, and the grading of recommendations, assessment, development, and evaluation (GRADE) method we evaluated the certainty of evidence and developed recommendations using the Evidence-to-Decision framework. We conducted an electronic vote, requiring >80% agreement amongst the panel for a recommendation to be adopted. The panel made a strong recommendation for a trial of awake proning in adult patients with COVID-19 related hypoxemic acute respiratory failure who are not invasively ventilated. Awake proning appears to reduce the risk of tracheal intubation, although it may not reduce mortality. The panel judged that most patients would want a trial of awake proning, although this may not be feasible in some patients and some patients may not tolerate it. However, given the high risk of clinical deterioration amongst these patients, awake proning should be conducted in an area where patients can be monitored by staff experienced in rapidly detecting and managing clinical deterioration. This RPG panel recommends a trial of awake prone positioning in patients with acute hypoxemic respiratory failure due to COVID-19.

Effect of Awake Prone Positioning on Endotracheal Intubation in Patients With COVID-19 and Acute Respiratory Failure: A Randomized Clinical Trial.

Importance: The efficacy and safety of prone positioning is unclear in nonintubated patients with acute hypoxemia and COVID-19. Objective: To evaluate the efficacy and adverse events of prone positioning in nonintubated adult patients with acute hypoxemia and COVID-19. Design, Setting, and Participants: Pragmatic, unblinded randomized clinical trial conducted at 21 hospitals in Canada, Kuwait, Saudi Arabia, and the US. Eligible adult patients with COVID-19 were not intubated and required oxygen (≥40%) or noninvasive ventilation. A total of 400 patients were enrolled between May 19, 2020, and May 18, 2021, and final follow-up was completed in July 2021. Intervention: Patients were randomized to awake prone positioning (n = 205) or usual care without prone positioning (control; n = 195). Main Outcomes and Measures: The primary outcome was endotracheal intubation within 30 days of randomization. The secondary outcomes included mortality at 60 days, days free from invasive mechanical ventilation or noninvasive ventilation at 30 days, days free from the intensive care unit or hospital at 60 days, adverse events, and serious adverse events. Results: Among the 400 patients who were randomized (mean age, 57.6 years [SD, 12.83 years]; 117 [29.3%] were women), all (100%) completed the trial. In the first 4 days after randomization, the median duration of prone positioning was 4.8 h/d (IQR, 1.8 to 8.0 h/d) in the awake prone positioning group vs 0 h/d (IQR, 0 to 0 h/d) in the control group. By day 30, 70 of 205 patients (34.1%) in the prone positioning group were intubated vs 79 of 195 patients (40.5%) in the control group (hazard ratio, 0.81 [95% CI, 0.59 to 1.12], P = .20; absolute difference, -6.37% [95% CI, -15.83% to 3.10%]). Prone positioning did not significantly reduce mortality at 60 days (hazard ratio, 0.93 [95% CI, 0.62 to 1.40], P = .54; absolute difference, -1.15% [95% CI, -9.40% to 7.10%]) and had no significant effect on days free from invasive mechanical ventilation or noninvasive ventilation at 30 days or on days free from the intensive care unit or hospital at 60 days. There were no serious adverse events in either group. In the awake prone positioning group, 21 patients (10%) experienced adverse events and the most frequently reported were musculoskeletal pain or discomfort from prone positioning (13 of 205 patients [6.34%]) and desaturation (2 of 205 patients [0.98%]). There were no reported adverse events in the control group. Conclusions and Relevance: In patients with acute hypoxemic respiratory failure from COVID-19, prone positioning, compared with usual care without prone positioning, did not significantly reduce endotracheal intubation at 30 days. However, the effect size for the primary study outcome was imprecise and does not exclude a clinically important benefit. Trial Registration: ClinicalTrials.gov Identifier: NCT04350723.

Restricted visitation policies in acute care settings during the COVID-19 pandemic: a scoping review.

BACKGROUND: Restricted visitation policies in acute care settings because of the COVID-19 pandemic have negative consequences. The objective of this scoping review is to identify impacts of restricted visitation policies in acute care settings, and describe perspectives and mitigation approaches among patients, families, and healthcare professionals. METHODS: We searched Medline, Embase, PsycINFO, Healthstar, CINAHL, Cochrane Central Register of Controlled Trials on January 01/2021, unrestricted, for published primary research records reporting any study design. We included secondary (e.g., reviews) and non-research records (e.g., commentaries), and performed manual searches in web-based resources. We excluded records that did not report primary data. Two reviewers independently abstracted data in duplicate. RESULTS: Of 7810 citations, we included 155 records. Sixty-six records (43%) were primary research; 29 (44%) case reports or case series, and 26 (39%) cohort studies; 21 (14%) were literature reviews and 8 (5%) were expert recommendations; 54 (35%) were commentary, editorial, or opinion pieces. Restricted visitation policies impacted coping and daily function (n = 31, 20%) and mental health outcomes (n = 29, 19%) of patients, families, and healthcare professionals. Participants described a need for coping and support (n = 107, 69%), connection and communication (n = 107, 69%), and awareness of state of well-being (n = 101, 65%). Eighty-seven approaches to mitigate impact of restricted visitation were identified, targeting families (n = 61, 70%), patients (n = 51, 59%), and healthcare professionals (n = 40, 46%). CONCLUSIONS: Patients, families, and healthcare professionals were impacted by restricted visitation polices in acute care settings during COVID-19. The consequences of this approach on patients and families are understudied and warrant evaluation of approaches to mitigate their impact. Future pandemic policy development should include the perspectives of patients, families, and healthcare professionals. TRIAL REGISTRATION: The review was registered on PROSPERO (CRD42020221662) and a protocol peer-reviewed prior to data extraction.

Tolerability and safety of awake prone positioning COVID-19 patients with severe hypoxemic respiratory failure.

PURPOSE: Prone positioning of non-intubated patients with coronavirus disease (COVID-19) and hypoxemic respiratory failure may prevent intubation and improve outcomes. Nevertheless, there are limited data on its feasibility, safety, and physiologic effects. The objective of our study was to assess the tolerability and safety of awake prone positioning in COVID-19 patients with hypoxemic respiratory failure. METHODS: This historical cohort study was performed across four hospitals in Calgary, Canada. Included patients had suspected COVID-19 and hypoxic respiratory failure requiring intensive care unit (ICU) consultation, and underwent awake prone positioning. The duration, frequency, tolerability, and adverse events from prone positioning were recorded. Respiratory parameters were assessed before, during, and after prone positioning. The primary outcome was the tolerability and safety of prone positioning. RESULTS: Seventeen patients (n = 12 ICU, n = 5 hospital ward) were included between April and May 2020. The median (range) number of prone positioning days was 1 (1-7) and the median number of sessions was 2 (1-6) per day. The duration of prone positioning was 75 (30-480) min, and the peripheral oxygen saturation was 91% (84-95) supine and 98% (92-100) prone. Limitations to prone position duration were pain/general discomfort (47%) and delirium (6%); 47% of patients had no limitations. Seven patients (41%) required intubation and two patients (12%) died. CONCLUSIONS: In a small sample, prone positioning non-intubated COVID-19 patients with severe hypoxemia was safe; however, many patients did not tolerate prolonged durations. Although patients had improved oxygenation and respiratory rate in the prone position, many still required intubation. Future studies are required to determine methods to improve the tolerability of awake prone positioning and whether there is an impact on clinical outcomes.

RéSUMé: OBJECTIF: Le positionnement ventral des patients non intubés atteints de coronavirus (COVID-19) et d'insuffisance respiratoire hypoxémique pourrait éviter de devoir les intuber et améliorer leurs pronostics. Nous ne disposons toutefois que de peu de données concernant la faisabilité, la sécurité et les effets physiologiques d'un tel positionnement. L'objectif de notre étude était d'évaluer la tolérabilité et la sécurité du positionnement ventral éveillé chez des patients atteints de la COVID-19 et d'insuffisance respiratoire hypoxémique. MéTHODE: Cette étude de cohorte historique a été réalisée dans 4 hôpitaux de Calgary, au Canada. Les patients inclus avaient une suspicion de COVID-19, souffraient d'insuffisance respiratoire hypoxique nécessitant une consultation à l'unité de soins intensifs (USI), et ont été positionnés sur le ventre éveillés. La durée, la fréquence, la tolérabilité et les événements indésirables liés au positionnement ventral ont été enregistrés. Les paramètres respiratoires étaient évalués avant, pendant et après le positionnement ventral. Les critères d'évaluation principaux étaient la tolérabilité et la sécurité du positionnement ventral. RéSULTATS: Dix-sept patients (n = 12 USI, n = 5 à l'étage) ont été inclus entre avril et mai 2020. Le nombre médian de jours de positionnement ventral était de 1 (fourchette 1-7) et de 2 sessions (fourchette 1-6) par jour. La durée médiane du positionnement ventral était de 75 min (fourchette, 30-480). La saturation en oxygène périphérique médiane en position dorsale était de 91 % (fourchette, 84-95) et de 98 % (fourchette 92-100) en position ventrale. Les obstacles à une durée prolongée de la position ventrale étaient la douleur / l'inconfort général (47%) et le delirium (6%). Au total, 47 % des patients n'ont fait état d'aucun obstacle. Sept patients (41 %) ont nécessité une intubation, et deux patients (12 %) sont décédés. CONCLUSION: Dans un petit échantillon, le positionnement ventral de patients non intubés atteints de COVID-19 et d'hypoxémie grave était sécuritaire, mais plusieurs patients n'ont pas toléré cette position pour une durée prolongée. Bien que l'oxygénation et la fréquence respiratoire des patients étaient améliorées en position ventrale, bon nombre ont tout de même nécessité une intubation. Des études futures sont nécessaires afin de déterminer quelles méthodes amélioreraient la tolérabilité du positionnement ventral éveillé et si cette position a un impact sur les devenirs cliniques.

Prone positioning for ARDS patients-tips for preparation and use during the COVID-19 pandemic.

Many patients with coronavirus disease (COVID-19) will develop acute respiratory distress syndrome (ARDS). Prone positioning is an important non-pharmacologic strategy that should be considered for all invasively ventilated patients with moderate to severe ARDS (including those with COVID-19). Prone positioning offers several physiologic and clinical benefits, including improving hypoxemia, matching ventilation with perfusion, reducing regional hyperinflation, and improving survival. To safely offer prone positioning, appropriate training, simulation, and health system planning should be undertaken. In this review, we offer ten tips, based on the Alberta provincial prone positioning strategy during COVID-19, to safely implement and improve the appropriate use of prone positioning. We provide special considerations for its use during the COVID-19 pandemic or future respiratory pandemics.

RéSUMé: De nombreux patients atteints de la maladie du coronavirus (COVID-19) développeront un syndrome de détresse respiratoire aiguë (SDRA, ARDS en anglais). Le positionnement ventral est une importante stratégie non pharmacologique qui devrait être envisagée pour tous les patients ventilés de manière invasive et souffrant d'un SDRA modéré à grave (y compris ceux atteints de la COVID-19). Le positionnement ventral offre plusieurs avantages physiologiques et cliniques, notamment l'amélioration de l'hypoxémie, une adéquation de la ventilation avec la perfusion, la réduction de l'hyperinflation régionale et l'amélioration de la survie. Pour offrir un positionnement ventral en toute sécurité, une formation, des simulations et une planification des ressources appropriées devraient être entreprises. Dans le cadre de ce compte rendu, nous proposons dix conseils, fondés sur la stratégie provinciale de positionnement ventral de l'Alberta au cours de la COVID-19, afin de mettre en œuvre et d'améliorer en toute sécurité l'utilisation appropriée du positionnement ventral. Nous décrivons des considérations particulières pour son utilisation pendant la pandémie de COVID-19 ou les futures pandémies respiratoires.

An environmental scan of visitation policies in Canadian intensive care units during the first wave of the COVID-19 pandemic.

PURPOSE: In response to the rapid spread of SARS-CoV-2, hospitals in Canada enacted temporary visitor restrictions to limit the spread of COVID-19 and preserve personal protective equipment supplies. This study describes the extent, variation, and fluctuation of Canadian adult intensive care unit (ICU) visitation policies before and during the first wave of the COVID-19 pandemic. METHODS: We conducted an environmental scan of Canadian hospital visitation policies throughout the first wave of the pandemic. We conducted a two-phased study analyzing both quantitative and qualitative data. RESULTS: We collected 257 documents with reference to visitation policies (preCOVID, 101 [39%]; midCOVID, 71 [28%]; and lateCOVID, 85 [33%]). Of these 257 documents, 38 (15%) were ICU-specific and 70 (27%) referenced the ICU. Most policies during the midCOVID/lateCOVID pandemic period allowed no visitors with specific exceptions (e.g., end-of-life). Framework analysis revealed five overarching themes: 1) reasons for restricted visitation policies; 2) visitation policies and expectations; 3) exceptions to visitation policy; 4) patient and family-centred care; and 5) communication and transparency. CONCLUSIONS: During the first wave of the COVID-19 pandemic, most Canadian hospitals had public-facing visitor restriction policies with specific exception categories, most commonly for patients at end-of-life, patients requiring assistance, or COVID-19 positive patients (varying from not allowed to case-by-case). Further studies are needed to understand the consistency with which visitation policies were operationalized and how they may have impacted patient- and family-centred care.

RéSUMé: OBJECTIF: En réponse à la propagation rapide du SRAS-CoV-2, les hôpitaux du Canada ont adopté des restrictions temporaires pour les visites afin de limiter la propagation de la COVID-19 et de préserver les stocks d'équipements de protection individuelle. Cette étude décrit l'ampleur, les variations et fluctuations des politiques canadiennes concernant les visites aux unités de soins intensifs (USI) pour adultes avant et pendant la première vague de la pandémie de COVID-19. MéTHODE: Nous avons réalisé une étude de milieu des politiques hospitalières canadiennes concernant les visites tout au long de la première vague de la pandémie. Nous avons mené une étude en deux phases analysant des données quantitatives et qualitatives. RéSULTATS: Nous avons recueilli 257 documents faisant référence aux politiques de visites (pré-COVID, 101 [39 %]; mid-COVID, 71 [28 %]; et COVID-tardif, 85 [33 %]). Sur ces 257 documents, 38 (15 %) étaient spécifiques aux USI et 70 (27 %) faisaient référence aux USI. La plupart des politiques au cours de la période pandémique mid-COVID/COVID-tardif ne permettaient aucune visite sauf exception spécifique (p. ex., fin de vie). L'analyse du cadre a révélé cinq thèmes généraux : 1) les raisons des restrictions des politiques de visites; 2) les politiques et attentes en matière de visites; 3) les exceptions aux politiques de visites; 4) les soins aux patients et centrés sur la famille; et 5) la communication et la transparence. CONCLUSION: Au cours de la première vague de la pandémie de COVID-19, la plupart des hôpitaux canadiens avaient des politiques de restriction des visites s'appliquant au public avec des catégories d'exception spécifiques, le plus souvent pour les patients en fin de vie, les patients nécessitant de l'aide ou les patients COVID-positifs (variant d'une interdiction au cas par cas). D'autres études sont nécessaires pour comprendre l'uniformité avec laquelle les politiques de visites ont été mises en œuvre et comment elles ont pu avoir une incidence sur les soins centrés sur le patient et la famille.

Allocation of intensive care resources during an infectious disease outbreak: a rapid review to inform practice.

BACKGROUND: The COVID-19 pandemic has placed sustained demand on health systems globally, and the capacity to provide critical care has been overwhelmed in some jurisdictions. It is unknown which triage criteria for allocation of resources perform best to inform health system decision-making. We sought to summarize and describe existing triage tools and ethical frameworks to aid healthcare decision-making during infectious disease outbreaks. METHODS: We conducted a rapid review of triage criteria and ethical frameworks for the allocation of critical care resources during epidemics and pandemics. We searched Medline, EMBASE, and SCOPUS from inception to November 3, 2020. Full-text screening and data abstraction were conducted independently and in duplicate by three reviewers. Articles were included if they were primary research, an adult critical care setting, and the framework described was related to an infectious disease outbreak. We summarized each triage tool and ethical guidelines or framework including their elements and operating characteristics using descriptive statistics. We assessed the quality of each article with applicable checklists tailored to each study design. RESULTS: From 11,539 unique citations, 697 full-text articles were reviewed and 83 articles were included. Fifty-nine described critical care triage protocols and 25 described ethical frameworks. Of these, four articles described both a protocol and ethical framework. Sixty articles described 52 unique triage criteria (29 algorithm-based, 23 point-based). Few algorithmic- or point-based triage protocols were good predictors of mortality with AUCs ranging from 0.51 (PMEWS) to 0.85 (admitting SOFA > 11). Most published triage protocols included the substantive values of duty to provide care, equity, stewardship and trust, and the procedural value of reason. CONCLUSIONS: This review summarizes available triage protocols and ethical guidelines to provide decision-makers with data to help select and tailor triage tools. Given the uncertainty about how the COVID-19 pandemic will progress and any future pandemics, jurisdictions should prepare by selecting and adapting a triage tool that works best for their circumstances.

Understanding ventilator-induced lung injury: The role of mechanical power.

Mechanical ventilation stands as a life-saving intervention in the management of respiratory failure. However, it carries the risk of ventilator-induced lung injury. Despite the adoption of lung-protective ventilation strategies, including lower tidal volumes and pressure limitations, mortality rates remain high, leaving room for innovative approaches. The concept of mechanical power has emerged as a comprehensive metric encompassing key ventilator parameters associated with the genesis of ventilator-induced lung injury, including volume, pressure, flow, resistance, and respiratory rate. While numerous animal and human studies have linked mechanical power and ventilator-induced lung injury, its practical implementation at the bedside is hindered by calculation challenges, lack of equation consensus, and the absence of an optimal threshold. To overcome the constraints of measuring static respiratory parameters, dynamic mechanical power is proposed for all patients, regardless of their ventilation mode. However, establishing a causal relationship is crucial for its potential implementation, and requires further research. The objective of this review is to explore the role of mechanical power in ventilator-induced lung injury, its association with patient outcomes, and the challenges and potential benefits of implementing a ventilation strategy based on mechanical power.

Endotyping in ARDS: one step forward in precision medicine.

BACKGROUND: The Berlin definition of acute respiratory distress syndrome (ARDS) includes only clinical characteristics. Understanding unique patient pathobiology may allow personalized treatment. We aimed to define and describe ARDS phenotypes/endotypes combining clinical and pathophysiologic parameters from a Canadian ARDS cohort. METHODS: A cohort of adult ARDS patients from multiple sites in Calgary, Canada, had plasma cytokine levels and clinical parameters measured in the first 24 h of ICU admission. We used a latent class model (LCM) to group the patients into several ARDS subgroups and identified the features differentiating those subgroups. We then discuss the subgroup effect on 30 day mortality. RESULTS: The LCM suggested three subgroups (n1 = 64, n2 = 86, and n3 = 30), and 23 out of 69 features made these subgroups distinct. The top five discriminating features were IL-8, IL-6, IL-10, TNF-a, and serum lactate. Mortality distinctively varied between subgroups. Individual clinical characteristics within the subgroup associated with mortality included mean PaO2/FiO2 ratio, pneumonia, platelet count, and bicarbonate negatively associated with mortality, while lactate, creatinine, shock, chronic kidney disease, vasopressor/ionotropic use, low GCS at admission, and sepsis were positively associated. IL-8 and Apache II were individual markers strongly associated with mortality (Area Under the Curve = 0.84). PERSPECTIVE: ARDS subgrouping using biomarkers and clinical characteristics is useful for categorizing a heterogeneous condition into several homogenous patient groups. This study found three ARDS subgroups using LCM; each subgroup has a different level of mortality. This model may also apply to developing further trial design, prognostication, and treatment selection.

Designing a Behaviour Change Wheel guided implementation strategy for a hypoxaemic respiratory failure and ARDS care pathway that targets barriers.

BACKGROUND: A significant gap exists between ideal evidence-based practice and real-world application of evidence-informed therapies for patients with hypoxaemic respiratory failure (HRF) and acute respiratory distress syndrome (ARDS). Pathways can improve the quality of care provided by helping integrate and organise the use of evidence informed practices, but barriers exist that can influence their adoption and successful implementation. We sought to identify barriers to the implementation of a best practice care pathway for HRF and ARDS and design an implementation science-based strategy targeting these barriers that is tailored to the critical care setting. METHODS: The intervention assessed was a previously described multidisciplinary, evidence-based, stakeholder-informed, integrated care pathway for HRF and ARDS. A survey questionnaire (12 open text questions) was administered to intensive care unit (ICU) clinicians (physicians, nurses, respiratory therapists) in 17 adult ICUs across Alberta. The Behaviour Change Wheel, capability, opportunity, motivation - behaviour components, and Theoretical Domains Framework (TDF) were used to perform qualitative analysis on open text responses to identify barriers to the use of the pathway. Behaviour change technique (BCT) taxonomy, and Affordability, Practicality, Effectiveness and cost-effectiveness, Acceptability, Side effects and safety and Equity (APEASE) criteria were used to design an implementation science-based strategy specific to the critical care context. RESULTS: Survey responses (692) resulted in 16 belief statements and 9 themes with 9 relevant TDF domains. Differences in responses between clinician professional group and hospital setting were common. Based on intervention functions linked to each belief statement and its relevant TDF domain, 26 candidate BCTs were identified and evaluated using APEASE criteria. 23 BCTs were selected and grouped to form 8 key components of a final strategy: Audit and feedback, education, training, clinical decision support, site champions, reminders, implementation support and empowerment. The final strategy was described using the template for intervention description and replication framework. CONCLUSIONS: Barriers to a best practice care pathway were identified and were amenable to the design of an implementation science-based mitigation strategy. Future work will evaluate the ability of this strategy to improve quality of care by assessing clinician behaviour change via better adherence to evidence-based care.

Methods for determination of optimal positive end-expiratory pressure: a protocol for a scoping review.

INTRODUCTION: Titrated application of positive end-expiratory pressure (PEEP) is an important part of any mechanical ventilation strategy. However, the method by which the optimal PEEP is determined and titrated varies widely. Methods for determining optimal PEEP have been assessed using a variety of different study designs and patient populations. We will conduct a scoping review to systematically identify all methods for determining optimal PEEP, and to identify the patient populations, outcomes measured and study designs used for each method. The goal will be to identify gaps in the optimal PEEP literature and identify areas where there may be an opportunity to further systematically synthesise and meta-analyse existing literature. METHODS AND ANALYSIS: Using scoping review methodology, we will generate a comprehensive search strategy based on inclusion and exclusion criteria generated using the population, concept, context framework. Five different databases will be searched (MEDLINE, EMBASE, CENTRAL, Web of Science and Scopus). Three investigators will independently screen titles and abstracts, and two investigators will independently complete full-text review and data extraction. Included citations will be categorised in terms of PEEP method, study design, patient population and outcomes measured. The methods for PEEP titration will be described in detail, including strengths and limitations. ETHICS AND DISSEMINATION: Given this is a synthesis of existing literature, ethics approval is not required. The results will be disseminated to stakeholders via presentation at local, regional and national levels, as well as publication in a high-impact critical care journal. There is also the potential to impact local clinical care protocols and inform broader clinical practice guidelines undertaken by societies.

Protocol and statistical analysis plan for the identification and treatment of hypoxemic respiratory failure and acute respiratory distress syndrome with protection, paralysis, and proning: A type-1 hybrid stepped-wedge cluster randomised effectiveness-implementation study.

Objective: To describe a study protocol and statistical analysis plan (SAP) for the identification and treatment of hypoxemic respiratory failure (HRF) and acute respiratory distress syndrome (ARDS) with protection, paralysis, and proning (TheraPPP) study prior to completion of recruitment, electronic data retrieval, and analysis of any data. Design: TheraPPP is a stepped-wedge cluster randomised study evaluating a care pathway for HRF and ARDS patients. This is a type-1 hybrid effectiveness-implementation study design evaluating both intervention effectiveness and implementation; however primarily powered for the effectiveness outcome. Setting: Seventeen adult intensive care units (ICUs) across Alberta, Canada. Participants: We estimate a sample size of 18816 mechanically ventilated patients, with 11424 patients preimplementation and 7392 patients postimplementation. We estimate 2688 sustained ARDS patients within our study cohort. Intervention: An evidence-based, stakeholder-informed, multidisciplinary care pathway called Venting Wisely that standardises diagnosis and treatment of HRF and ARDS patients. Main outcome measures: The primary outcome is 28-day ventilator-free days (VFDs). The primary analysis will compare the mean 28-day VFDs preimplementation and postimplementation using a mixed-effects linear regression model. Prespecified subgroups include sex, age, HRF, ARDS, COVID-19, cardiac surgery, body mass index, height, illness acuity, and ICU volume. Results: This protocol and SAP are reported using the Standard Protocol Items: Recommendations for Interventional Trials guidance and the Guidelines for the Content of Statistical Analysis Plans in Clinical Trials. The study received ethics approval and was registered (ClinicalTrials.gov-NCT04744298) prior to patient enrolment. Conclusions: TheraPPP will evaluate the effectiveness and implementation of an HRF and ARDS care pathway.

Efficacy of awake prone positioning in patients with covid-19 related hypoxemic respiratory failure: systematic review and meta-analysis of randomized trials.

OBJECTIVE: To determine the efficacy and safety of awake prone positioning versus usual care in non-intubated adults with hypoxemic respiratory failure due to covid-19. DESIGN: Systematic review with frequentist and bayesian meta-analyses. STUDY ELIGIBILITY: Randomized trials comparing awake prone positioning versus usual care in adults with covid-19 related hypoxemic respiratory failure. Information sources were Medline, Embase, and the Cochrane Central Register of Controlled Trials from inception to 4 March 2022. DATA EXTRACTION AND SYNTHESIS: Two reviewers independently extracted data and assessed risk of bias. Random effects meta-analyses were performed for the primary and secondary outcomes. Bayesian meta-analyses were performed for endotracheal intubation and mortality outcomes. GRADE certainty of evidence was assessed for outcomes. MAIN OUTCOME MEASURES: The primary outcome was endotracheal intubation. Secondary outcomes were mortality, ventilator-free days, intensive care unit (ICU) and hospital length of stay, escalation of oxygen modality, change in oxygenation and respiratory rate, and adverse events. RESULTS: 17 trials (2931 patients) met the eligibility criteria. 12 trials were at low risk of bias, three had some concerns, and two were at high risk. Awake prone positioning reduced the risk of endotracheal intubation compared with usual care (crude average 24.2% v 29.8%, relative risk 0.83, 95% confidence interval 0.73 to 0.94; high certainty). This translates to 55 fewer intubations per 1000 patients (95% confidence interval 87 to 19 fewer intubations). Awake prone positioning did not significantly affect secondary outcomes, including mortality (15.6% v 17.2%, relative risk 0.90, 0.76 to 1.07; high certainty), ventilator-free days (mean difference 0.97 days, 95% confidence interval -0.5 to 3.4; low certainty), ICU length of stay (-2.1 days, -4.5 to 0.4; low certainty), hospital length of stay (-0.09 days, -0.69 to 0.51; moderate certainty), and escalation of oxygen modality (21.4% v 23.0%, relative risk 1.04, 0.74 to 1.44; low certainty). Adverse events related to awake prone positioning were uncommon. Bayesian meta-analysis showed a high probability of benefit with awake prone positioning for endotracheal intubation (non-informative prior, mean relative risk 0.83, 95% credible interval 0.70 to 0.97; posterior probability for relative risk <0.95=96%) but lower probability for mortality (0.90, 0.73 to 1.13; <0.95=68%). CONCLUSIONS: Awake prone positioning compared with usual care reduces the risk of endotracheal intubation in adults with hypoxemic respiratory failure due to covid-19 but probably has little to no effect on mortality or other outcomes. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42022314856.

Development and Content Validation of a Multidisciplinary Standardized Management Pathway for Hypoxemic Respiratory Failure and Acute Respiratory Distress Syndrome.

OBJECTIVES: Treatment of hypoxemic respiratory failure and acute respiratory distress syndrome is complex. Evidence-based therapies that can improve survival and guidelines advocating their use exist; however, implementation is inconsistent. Our objective was to develop and validate an evidence-based, stakeholder-informed standardized management pathway for hypoxemic respiratory failure and acute respiratory distress syndrome to improve adherence to best practice. DESIGN: A standardized management pathway was developed using a modified Delphi consensus process with a multidisciplinary group of ICU clinicians. The proposed pathway was externally validated with a survey involving multidisciplinary stakeholders and clinicians. SETTING: In-person meeting and web-based surveys of ICU clinicians from 17 adult ICUs in the province of Alberta, Canada. INTERVENTION: Not applicable. MEASUREMENTS AND MAIN RESULTS: The consensus panel was comprised of 30 ICU clinicians (4 nurses, 10 respiratory therapists, 15 intensivists, 1 nurse practitioner; median years of practice 17 [interquartile range, 13-21]). Ninety-one components were serially rated and revised over two rounds of online and one in-person review. The final pathway included 46 elements. For the validation survey, 692 responses (including 59% nurses, 33% respiratory therapists, 7% intensivists and 1% nurse practitioners) were received. Agreement of greater than 75% was achieved on 43 of 46 pathway elements. CONCLUSIONS: A 46-element evidence-informed hypoxemic respiratory failure and acute respiratory distress syndrome standardized management pathway was developed and demonstrated to have content validity.