Study protocol for a randomized controlled trial of Proportional Assist Ventilation for Minimizing the Duration of Mechanical Ventilation: the PROMIZING study.

BACKGROUND: Proportional assist ventilation with load-adjustable gain factors (PAV+) is a mechanical ventilation mode that delivers assistance to breathe in proportion to the patient's effort. The proportional assistance, called the gain, can be adjusted by the clinician to maintain the patient's respiratory effort or workload within a normal range. Short-term and physiological benefits of this mode compared to pressure support ventilation (PSV) include better patient-ventilator synchrony and a more physiological response to changes in ventilatory demand. METHODS: The objective of this multi-centre randomized controlled trial (RCT) is to determine if, for patients with acute respiratory failure, ventilation with PAV+ will result in a shorter time to successful extubation than with PSV. This multi-centre open-label clinical trial plans to involve approximately 20 sites in several continents. Once eligibility is determined, patients must tolerate a short-term PSV trial and either (1) not meet general weaning criteria or (2) fail a 2-min Zero Continuous Positive Airway Pressure (CPAP) Trial using the rapid shallow breathing index, or (3) fail a spontaneous breathing trial (SBT), in this sequence. Then, participants in this study will be randomized to either PSV or PAV+ in a 1:1 ratio. PAV+ will be set according to a target of muscular pressure. The weaning process will be identical in the two arms. Time to liberation will be the primary outcome; ventilator-free days and other outcomes will be measured. DISCUSSION: Meta-analyses comparing PAV+ to PSV suggest PAV+ may benefit patients and decrease healthcare costs but no powered study to date has targeted the difficult to wean patient population most likely to benefit from the intervention, or used consistent timing for the implementation of PAV+. Our enrolment strategy, primary outcome measure, and liberation approaches may be useful for studying mechanical ventilation and weaning and can offer important results for patients. TRIAL REGISTRATION: ClinicalTrials.gov NCT02447692 . Prospectively registered on May 19, 2015.

The effects of acute care hospitalization on health and cost trajectories for nursing home residents: A matched cohort study.

Thirty five percent to sixty seven percent of admissions to acute care hospitals from nursing homes are potentially preventable. Limited data exist regarding clinical and cost trajectories post an acute care hospitalization. To describe clinical impact and post-hospitalization costs associated with acute care admissions for nursing home residents. Analysis of population-based data. The 65,996 nursing home residents from a total of 645 nursing homes. Clinical outcomes assessed with the Changes in Health, End-stage disease and Symptoms and Signs (CHESS) scores, and monthly costs. Post-index date, hospitalized residents worsened their clinical conditions, with increases in CHESS scores (CHESS 3 + 24.5% vs 7.6%, SD 0.46), more limitations in activities of daily living (ADL) (86.1% vs 76.0%, SD 0.23), more prescriptions (+1.64 95% CI 1.43-1.86, P < .001), falls (30.9% vs 18.1%, SD 0.16), pressure ulcers (16.4% vs 8.6%, SD 0.37), and bowel incontinence (47.3% vs 39.3%, SD 0.35). Acute care hospitalizations for nursing home residents had a significant impact on their clinical and cost trajectories upon return to the nursing home. Investments in preventive strategies at the nursing home level, and to mitigate functional decline of hospitalized frail elderly residents may lead to improved quality of care and reduced costs for this population. Pre-hospitalization costs were not different between the hospitalized and control groups but showed an immediate increase post-hospitalization (CAD 1882.60 per month, P < .001).

Co-designed and consensus based development of a quality improvement checklist of patient and family-centered actionable processes of care for adults with persistent critical illness.

PURPOSE: Few quality improvement tools specific to patients with persistent or chronic critical illness exist to aid delivery of high-quality care. Using experience-based co-design methods, we sought consensus from key stakeholders on the most important actionable processes of care for inclusion in a quality improvement checklist. METHODS: Item generation methods: systematic review, semi-structured interviews (ICU survivors and family) members, touchpoint video creation, and semi-structured interviews (ICU clinicians). Consensus methods: modified online Delphi and a virtual meeting using nominal group technique methods. RESULTS: We enrolled 138 ICU interprofessional team, patients, and family members. We obtained consensus on a quality improvement checklist comprising 11 core domains: patient and family involvement in decision-making; patient communication; physical comfort and complication prevention; promoting self-care and normalcy; ventilator weaning; physical therapy; swallowing; pharmacotherapy; psychological issues; delirium; and appropriate referrals. An additional 27 actionable processes are contained within 6 core domains that provide more specific direction on the actionable process to be targeted. CONCLUSIONS: Using a highly collaborative and methodologically rigorous process, we generated a quality improvement checklist of actionable processes to improve patient and family-centred care considered important by key stakeholders. Future research is needed to understand optimal implementation strategies and impact on outcomes and experience.

Effect of oral chlorhexidine de-adoption and implementation of an oral care bundle on mortality for mechanically ventilated patients in the intensive care unit (CHORAL): a multi-center stepped wedge cluster-randomized controlled trial.

PURPOSE: Oral chlorhexidine is used widely for mechanically ventilated patients to prevent pneumonia, but recent studies show an association with excess mortality. We examined whether de-adoption of chlorhexidine and parallel implementation of a standardized oral care bundle reduces intensive care unit (ICU) mortality in mechanically ventilated patients. METHODS: A stepped wedge cluster-randomized controlled trial with concurrent process evaluation in 6 ICUs in Toronto, Canada. Clusters were randomized to de-adopt chlorhexidine and implement a standardized oral care bundle at 2-month intervals. The primary outcome was ICU mortality. Secondary outcomes were time to infection-related ventilator-associated complications (IVACs), oral procedural pain and oral health dysfunction. An exploratory post hoc analysis examined time to extubation in survivors. RESULTS: A total of 3260 patients were enrolled; 1560 control, 1700 intervention. ICU mortality for the intervention and control periods were 399 (23.5%) and 330 (21.2%), respectively (adjusted odds ratio [aOR], 1.13; 95% confidence interval [CI] 0.82 to 1.54; P = 0.46). Time to IVACs (adjusted hazard ratio [aHR], 1.06; 95% CI 0.44 to 2.57; P = 0.90), time to extubation (aHR 1.03; 95% CI 0.85 to 1.23; P = 0.79) (survivors) and oral procedural pain (aOR, 0.62; 95% CI 0.34 to 1.10; P = 0.10) were similar between control and intervention periods. However, oral health dysfunction scores (- 0.96; 95% CI - 1.75 to - 0.17; P = 0.02) improved in the intervention period. CONCLUSION: Among mechanically ventilated ICU patients, no benefit was observed for de-adoption of chlorhexidine and implementation of an oral care bundle on ICU mortality, IVACs, oral procedural pain, or time to extubation. The intervention may improve oral health.

Interventions to enable communication for adult patients requiring an artificial airway with or without mechanical ventilator support.

BACKGROUND: Inability to communicate in a manner that can be understood causes extreme distress for people requiring an artificial airway and has implications for care quality and patient safety. Options for aided communication include non-vocal, speech-generating, and voice-enabling aids. OBJECTIVES: To assess effectiveness of communication aids for people requiring an artificial airway (endotracheal or tracheostomy tube), defined as the proportion of people able to: use a non-vocal communication aid to communicate at least one symptom, need, or preference; or use a voice-enabling communication aid to phonate to produce at least one intelligible word. To assess time to communication/phonation; perceptions of communication; communication quality/success; quality of life; psychological distress; length of stay and costs; and adverse events. SEARCH METHODS: We searched the Cochrane Library (Wiley version), MEDLINE (OvidSP), Embase (OvidSP), three other databases, and grey literature from inception to 30 July 2020. SELECTION CRITERIA: We included randomised controlled trials (RCTs), quasi-RCTs, cluster-RCTs, controlled non-randomised parallel group, and before-after studies evaluating communication aids used in adults with an artificial airway. DATA COLLECTION AND ANALYSIS: We used standard methodological procedures recommended by Cochrane. Two review authors independently performed data extraction and assessment of risk of bias. MAIN RESULTS: We included 11 studies (1931 participants) conducted in intensive care units (ICUs). Eight evaluated non-vocal communication aids and three voice-enabling aids. Usual care was the comparator for all. For six studies, this comprised no aid; usual care in the remaining five studies comprised use of various communication aids. Overall, our confidence in results regarding effectiveness of communication interventions was very low due to imprecision, measurement heterogeneity, inconsistency in results, and most studies at high or unclear risk of bias across multiple domains. No non-vocal aid studies reported our primary outcome. We are uncertain of the effects of early use of a voice-enabling aid compared to routine use on ability to phonate at least one intelligible word (risk ratio (RR) 3.03, 95% confidence interval (CI) 0.18 to 50.08; 2 studies; very low-certainty evidence). Compared to usual care without aids, we are uncertain about effects of a non-vocal aid (communication board) on patient satisfaction (standardised mean difference (SMD) 2.92, 95% CI 1.52 to 4.33; 4 studies; very low-certainty evidence). No studies of non-vocal aids reported quality of life. Low-certainty evidence from two studies suggests early use of a voice-enabling aid may have no effect on quality of life (MD 2.27, 95% CI -7.21 to 11.75). Conceptual differences in measures of psychological distress precluded data pooling; however, intervention arm participants reported less distress suggesting there might be benefit, but our certainty in the evidence is very low. Low-certainty evidence suggest voice-enabling aids have little or no effect on ICU length of stay; we were unable to determine effects of non-vocal aids. Three studies reported different adverse events (physical restraint use, bleeding following tracheostomy, and respiratory parameters indicating respiratory decompensation). Adverse event rates were similar between arms in all three studies. However, uncertainty remains as to any harm associated with communication aids. AUTHORS' CONCLUSIONS: Due to a lack of high-quality studies, imprecision, inconsistency of results, and measurement heterogeneity,  the evidence provides insufficient information to guide practice as to which communication aid is more appropriate and when to use them. Understanding effectiveness of communication aids would benefit from development of a core outcome measurement set.

Discordances Between Factors Associated With Withholding Extubation and Extubation Failure After a Successful Spontaneous Breathing Trial.

OBJECTIVES: To identify whether factors associated with withholding extubation in the ICU also predict the risk of extubation failure. DESIGN: Retrospective cohort study. SETTING: Eight medical-surgical ICUs in Toronto. PATIENTS: Adult patients receiving invasive mechanical ventilation, with a first successful spontaneous breathing trial within 28 days of initial ICU admission. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: The primary end point had three mutually exclusive levels, including: 1) withholding extubation after a successful spontaneous breathing trial, 2) extubation failure within 48 hours, and 3) successful extubation. Among 9,910 patients, 38% of patients were not extubated within 24 hours of their first successful spontaneous breathing trial. A total of 12.9% of patients who were promptly extubated failed within the next 48 hours. Several discrepancies were evident in the association of factors with risk of withholding extubation and extubation failure. Specifically, both age and female sex were associated with withholding extubation (odds ratio, 1.07; 95% CI, 1.03-1.11; and odds ratio, 1.13; 95% CI, 1.02-1.26, respectively) but not a higher risk of failed extubation (odds ratio, 0.99; 95% CI, 0.93-1.05; and odds ratio, 0.93; 95% CI, 0.77-1.11, respectively). Conversely, both acute cardiovascular conditions and intubation for hypoxemic respiratory failure were associated with a higher risk of failed extubation (odds ratio, 1.32; 95% CI, 1.06-1.66; and odds ratio, 1.46; 95% CI, 1.16-1.82, respectively) but not a higher odds of a withheld extubation attempt (odds ratio, 0.79; 95% CI, 0.68-0.91; and odds ratio, 1.07; 95% CI, 0.93-1.23, respectively). CONCLUSIONS: Several factors showed discordance between the decision to withhold extubation and the risk of extubation failure. This discordance may lead to longer duration of mechanical ventilation or higher reintubation rates. Improving the decision-making behind extubation may help to reduce both exposure to invasive mechanical ventilation and extubation failure.

Compliance With Evidence-Based Processes of Care After Transitions Between Staff Intensivists.

OBJECTIVES: We sought to evaluate the impact of transitions of care among staff intensivists on the compliance with evidence-based processes of care. DESIGN: Cohort study using data from the Toronto Intensive Care Observational Registry. SETTING: Seven academic ICUs in Toronto, Ontario. PATIENTS: Critically ill mechanically ventilated adult patients. INTERVENTIONS: We explored the effects of the weekly transition of care among staff intensivists on compliance with three evidence-based processes of care (spontaneous breathing trials, lung-protective ventilation, and neuromuscular blocking agents). Two practices that are less guided by evidence (early discontinuation of antibiotics and extubation attempts) served as positive controls. We conducted the analysis using generalized estimating equations to account for clustering at the patient level. MEASUREMENTS AND MAIN RESULTS: The cohort consisted of 10,570 patients admitted between June 2014 and August 2018. Compliance varied for each practice (63.6%, 42.5%, and 21.1% for lung-protective ventilation, spontaneous breathing trials, and neuromuscular blockade, respectively). There was no effect of transitions of care on compliance with spontaneous breathing trials (odds ratio, 1.00; 95% CI, 0.95-1.07), lung-protective ventilation (odds ratio, 1.07, 95% CI, 0.90-1.26), or neuromuscular blockade use (odds ratio, 0.95; 95% CI, 0.75-1.20). However, early antibiotic discontinuation was more likely (odds ratio, 1.23; 95% CI, 1.06-1.42) and extubation attempts were less frequent (odds ratio, 0.77; 95% CI, 0.65-0.93) after a transition of care. CONCLUSIONS: We observed no significant impact of transitions of care between individual staff physicians on evidence-based processes of care for mechanically ventilated adult patients. However, transitions were associated with a lower likelihood of extubation and higher odds of earlier discontinuation of antibiotics.

Performance Measure Development, Use, and Measurement of Effectiveness Using the Guideline on Mechanical Ventilation in Acute Respiratory Distress Syndrome. An Official American Thoracic Society Workshop Report.

Guideline implementation tools are designed to improve uptake of guideline recommendations in clinical settings but do not uniformly accompany the clinical practice guideline documents. Performance measures are a type of guideline implementation tool with the potential to catalyze behavior change and greater adherence to clinical practice guidelines. However, many performance measures suffer from serious flaws in their design and application, prompting the American Thoracic Society (ATS) to define its own performance measure development standards in a previous workshop in 2012. This report summarizes the proceedings of a follow-up workshop convened to advance the ATS's work in performance measure development and guideline implementation. To illustrate the application of the ATS's performance measure development framework, we used the example of a low-tidal volume ventilation performance measure created de novo from the 2017 ATS/European Society of Intensive Care Medicine/Society of Critical Care Medicine mechanical ventilation in acute respiratory distress syndrome clinical practice guideline. We include a detailed explanation of the rationale for the specifications chosen, identification of areas in need of further validity testing, and a preliminary strategy for pilot testing of the performance measure. Pending additional resources and broader performance measure expertise, issuing "preliminary performance measures" and their specifications alongside an ATS clinical practice guideline offers a first step to further the ATS's guideline implementation agenda. We recommend selectively proceeding with full performance measure development for those measures with positive early user feedback and the greatest potential impact in accordance with ATS leadership guidance.

Protocol for a multi-centered, stepped wedge, cluster randomized controlled trial of the de-adoption of oral chlorhexidine prophylaxis and implementation of an oral care bundle for mechanically ventilated critically ill patients: the CHORAL study.

BACKGROUND: Routine application of chlorhexidine oral rinse is recommended to reduce risk of ventilator-associated pneumonia (VAP) in mechanically ventilated patients. Recent reappraisal of the evidence from two meta-analyses suggests chlorhexidine may cause excess mortality in non-cardiac surgery patients and does not reduce VAP. Mechanisms for possible excess mortality are unclear. The CHORAL study will evaluate the impact of de-adopting chlorhexidine and implementing an oral care bundle (excluding chlorhexidine) on mortality, infection-related ventilator-associated complications (IVACs), and oral health status. METHODS: The CHORAL study is a stepped wedge, cluster randomized controlled trial in six academic intensive care units (ICUs) in Toronto, Canada. Clusters (ICU) will be randomly allocated to six sequential steps over a 14-month period to de-adopt oral chlorhexidine and implement a standardized oral care bundle (oral assessment, tooth brushing, moisturization, and secretion removal). On study commencement, all clusters begin with a control period in which the standard of care is oral chlorhexidine. Clusters then begin crossover from control to intervention every 2 months according to the randomization schedule. Participants include all mechanically ventilated adults eligible to receive the standardized oral care bundle. The primary outcome is ICU mortality; secondary outcomes are IVACs and oral health status. We will determine demographics, antibiotic usage, mortality, and IVAC rates from a validated local ICU clinical registry. With six clusters and 50 ventilated patients on average each month per cluster, we estimate that 4200 patients provide 80% power after accounting for intracluster correlation to detect an absolute reduction in mortality of 5.5%. We will analyze our primary outcome of mortality using a generalized linear mixed model adjusting for time to account for secular trends. We will conduct a process evaluation to determine intervention fidelity and to inform interpretation of the trial results. DISCUSSION: The CHORAL study will inform understanding of the effectiveness of de-adoption of oral chlorhexidine and implementation of a standardized oral care bundle for decreasing ICU mortality and IVAC rates while improving oral health status. Our process evaluation will inform clinicians and decision makers about intervention delivery to support future de-adoption if justified by trial results. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03382730 . Registered on December 26, 2017.

Handovers Among Staff Intensivists: A Study of Information Loss and Clinical Accuracy to Anticipate Events.

OBJECTIVES: Handovers are associated with medical errors, and our primary objective is to identify missed diagnosis and goals immediately after a shift handover. Our secondary objective is to assess clinicians' diagnostic accuracy in anticipating clinical events during the night shift. DESIGN: Single-center prospective observational cohort study. SETTING: Thirty-bed tertiary ICU in Sao Paulo, Brazil. PATIENTS: Three-hundred fifty-two patient encounters over 44 day-to-night handovers. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: We used a multimethods approach to measure transmission of information among staff physicians on diagnoses and goals for the night shift. We surveyed clinicians immediately after a handover and identified clinical events through chart abstractions and interviews with clinicians the next morning. Nighttime clinicians correctly identified 454 of 857 diagnoses (53%; 95% CI 50-56) and 123 of 304 goals (40%; 95% CI, 35-46). Daytime clinicians were more sensitive (65% vs 46%; p < 0.01) but less specific (82% vs 91%; p < 0.01) than nighttime clinicians in anticipating clinical events at night, resulting in similar accuracy (area under the receiver operating characteristic curve, 0.74 [95% CI, 0.68-0.79] vs 0.68 [95% CI 0.63-0.74]; p = 0.09). The positive predictive value of both daytime and nighttime clinicians was low (13% vs 17%; p = 0.2). Gaps in diagnosis and anticipation of events were more pronounced in neurologic diagnoses. CONCLUSIONS: Among staff intensivists, diagnoses and goals of treatment are either not conveyed or retained 50-60% of the cases immediately after a handover. Clinicians have limited ability to anticipate events, and the expectation that anticipatory guidance can inform handovers needs to be balanced against information overload. Handovers among staff intensivists showed more gaps in the identification of diagnostic uncertainty and for neurologic diagnoses, which could benefit from communication strategies such as cognitive checklists, prioritizing discussion of neurologic patients, and brief combined clinical examination at handover.

Feasibility of the electrolarynx for enabling communication in the chronically critically ill: The EECCHO study.

PURPOSE: To assess feasibility of producing intelligible and comprehensible speech with an electrolarynx; measure anxiety, communication ease, and satisfaction before/after electrolarynx training; and identify barriers/facilitators. METHODS: We included tracheostomized adults from 3 units following commands, reading English, and mouthing words. On enrolment, we measured anxiety, ease, and satisfaction with communication. We gave electrolarynx instruction for ≤5 days then 2 independent raters assessed intelligibility, sentence comprehensibility (9-point difficulty scale), and Electrolarynx Effectiveness Score (EES), and re-evaluated anxiety, communication ease, and satisfaction. Interviews explored barriers/facilitators. MEASUREMENTS AND MAIN RESULTS: We recruited 24 participants (Jan2015-Dec2016). Mean (SD) intelligibility was 45%(18%) words correct: 57%(21%) when facing. Mean comprehension difficulty was 6.4(2.0) overall, indicating moderate difficulty (5.5(2.5) scored visualizing). Mean EES was 2.9(1.0) (3 = improved lip-reading through recognizable sounds). Anxiety decreased from median 3.8 to 2.0 (P = .007). Communication was rated easier (median 15 vs 12, P = .04) whereas satisfaction remained similar (P = .06). Facilitators included device friendliness, patient independence, and word intelligibility. Barriers were patient weakness, difficulty positioning the device, and limited sentence as opposed to word intelligibility. CONCLUSION: The electrolarynx may aid intelligible speech for some tracheostomized patients if the communication partner can visualize the users face, and reduce anxiety and make patient perceived communication easier.

Expanding the scope of Critical Care Rapid Response Teams: a feasible approach to identify adverse events. A prospective observational cohort.

INTRODUCTION: Adverse events (AEs) affect 3-12% of hospitalised patients. These are estimates from a labour-intensive chart review process,which is not feasible outside research. Clinical deterioration on the wards triggers a rapid response teams (RRTs) consult and can be used to identify an AE prospectively. OBJECTIVES: To demonstrate the feasibility of using RRT to detect AEs and compare this methodology to the rates reported using an electronic safety reporting system. METHODS: Prospective observational cohort of RRT consults. Three independent physicians reviewed all cases for the occurrence of an AE and its preventability. We summarise AEs as rates per 1000 patient-days, and compared the rates between RRT and the safety reporting system using a Poisson model. RESULTS: There were 8713 hospital admissions, with 531 RRT consults and 247 (2.8%) cases included. Forty-four (17.8%) and 35 cases (14.2%) were judged as AEs and preventable AEs, respectively. RRT identified 0.52 AE/1000 patient-days, compared with 0.21 AE/1000 patient-days detected through the electronic safety reporting system (rate ratio 2.4, 95% CI 1.4 to 4.2, p=0.0014). Patients in surgical wards had more AEs (0.83/1000 vs 0.36/1000, p<0.01) and preventable AEs (0.70 vs 0.21, p<0.01) than patients in medical wards. Agreement for AE (κ 0.46, 95% CI 0.39 to 0.53) and preventable AE (κ 0.47, 95% CI 0.40 to 0.53) was moderate among reviewers. CONCLUSIONS: Reviewing RRT consults identified a high proportion of AEs and preventable AEs. This methodology detected twice as many AEs as the hospital's safety reporting system. RRT clinicians provide a complementary and more sensitive mechanism than traditional safety reporting systems to identify possible AEs in hospitals.

Nighttime cross-coverage is associated with decreased intensive care unit mortality. A single-center study.

RATIONALE: Cross-coverage is associated with medical errors caused by miscommunication during handoffs. However, no direct evidence links handoffs to outcomes, or explains the mechanisms leading to outcomes. Furthermore, the previous literature may overestimate the impact of handoffs because of hindsight bias. OBJECTIVES: To explore the effects of nighttime cross-coverage on mortality and decision making in critically ill patients. METHODS: Observational cohort of 629 consecutive critically ill admissions, admitted for at least 48 hours, and critical care fellows in an academic hospital. MEASUREMENTS AND MAIN RESULTS: Intensive care unit (ICU) mortality and nighttime decisions. Our exposure variable was cross-covering status of fellows. We observed a decrease in ICU mortality (odds ratio, 0.77 per 1 d; 0.60-0.99; P = 0.04), a higher number of nighttime decisions (19.3 vs. 10.4%; odds ratio, 2.02; 95% confidence interval [CI], 1.03-3.95; P = 0.04), an increase in fentanyl equivalents administered to patients at night (difference, +10.2 µg/h; 95% CI, +1.4 to +19.0; P = 0.02), and an increase in transfusions at night (difference, +465 ml; 95% CI, +98 to +832; P = 0.01) when fellows were cross-covering. CONCLUSIONS: In this single-center study exposure to cross-covering fellows was associated with a decrease in ICU mortality and with more nighttime decisions. Our findings contradict the dominant hypothesis that cross-coverage is associated with worse outcomes, and suggest that a "second look" by cross-covering fellows may mitigate cognitive errors. Future interventions to improve patient safety in ICUs should focus both on the quality of handoffs and on strategies to decrease cognitive errors.