Showing papers by "Deborah J. Cook published in 2019"

Effect of Titrating Positive End-Expiratory Pressure (PEEP) With an Esophageal Pressure-Guided Strategy vs an Empirical High PEEP-Fio2 Strategy on Death and Days Free From Mechanical Ventilation Among Patients With Acute Respiratory Distress Syndrome: A Randomized Clinical Trial

Abstract: Importance Adjusting positive end-expiratory pressure (PEEP) to offset pleural pressure might attenuate lung injury and improve patient outcomes in acute respiratory distress syndrome (ARDS). Objective To determine whether PEEP titration guided by esophageal pressure (PES), an estimate of pleural pressure, was more effective than empirical high PEEP-fraction of inspired oxygen (Fio2) in moderate to severe ARDS. Design, setting, and participants Phase 2 randomized clinical trial conducted at 14 hospitals in North America. Two hundred mechanically ventilated patients aged 16 years and older with moderate to severe ARDS (Pao2:Fio2 ≤200 mm Hg) were enrolled between October 31, 2012, and September 14, 2017; long-term follow-up was completed July 30, 2018. Interventions Participants were randomized to PES-guided PEEP (n = 102) or empirical high PEEP-Fio2 (n = 98). All participants received low tidal volumes. Main outcomes and measures The primary outcome was a ranked composite score incorporating death and days free from mechanical ventilation among survivors through day 28. Prespecified secondary outcomes included 28-day mortality, days free from mechanical ventilation among survivors, and need for rescue therapy. Results Two hundred patients were enrolled (mean [SD] age, 56 [16] years; 46% female) and completed 28-day follow-up. The primary composite end point was not significantly different between treatment groups (probability of more favorable outcome with PES-guided PEEP: 49.6% [95% CI, 41.7% to 57.5%]; P = .92). At 28 days, 33 of 102 patients (32.4%) assigned to PES-guided PEEP and 30 of 98 patients (30.6%) assigned to empirical PEEP-Fio2 died (risk difference, 1.7% [95% CI, -11.1% to 14.6%]; P = .88). Days free from mechanical ventilation among survivors was not significantly different (median [interquartile range]: 22 [15-24] vs 21 [16.5-24] days; median difference, 0 [95% CI, -1 to 2] days; P = .85). Patients assigned to PES-guided PEEP were significantly less likely to receive rescue therapy (4/102 [3.9%] vs 12/98 [12.2%]; risk difference, -8.3% [95% CI, -15.8% to -0.8%]; P = .04). None of the 7 other prespecified secondary clinical end points were significantly different. Adverse events included gross barotrauma, which occurred in 6 patients with PES-guided PEEP and 5 patients with empirical PEEP-Fio2. Conclusions and relevance Among patients with moderate to severe ARDS, PES-guided PEEP, compared with empirical high PEEP-Fio2, resulted in no significant difference in death and days free from mechanical ventilation. These findings do not support PES-guided PEEP titration in ARDS. Trial registration ClinicalTrials.gov Identifier NCT01681225.

Frailty and invasive mechanical ventilation: association with outcomes, extubation failure, and tracheostomy

Abstract: Invasive mechanical ventilation is a common form of life support provided to critically ill patients. Frailty is an emerging prognostic factor for poor outcome in the Intensive Care Unit (ICU); however, its association with adverse outcomes following invasive mechanical ventilation is unknown. We sought to evaluate the association between frailty, defined by the Clinical Frailty Scale (CFS), and outcomes of ICU patients receiving invasive mechanical ventilation. We performed a retrospective analysis (2011–2016) of a prospectively collected registry from two hospitals of consecutive ICU patients ≥ 18 years of age receiving invasive mechanical ventilation. CFS scores were based on recorded pre-admission function at the time of hospital admission. The primary outcome was hospital mortality. Secondary outcomes included discharge to long-term care, extubation failure at time of first liberation attempt, and tracheostomy. We included 8110 patients, and 2529 (31.2%) had frailty (CFS ≥ 5). Frailty was associated with increased odds of hospital death (adjusted odds ratio [aOR]: 1.24 [95% confidence interval [CI] 1.10–1.40) and discharge to long-term care (aOR 1.21 [95% CI 1.13–1.35]). As compared to patients without frailty, patients with frailty had increased odds of extubation failure (aOR 1.17 [95% CI 1.04–1.37]), hospital death following extubation failure (aOR 1.18 [95% CI 1.07–1.28]), tracheostomy (aOR 1.17 [95% CI 1.01–1.36]), and hospital death following tracheostomy (aOR 1.14 [95% CI 1.03–1.25]). The presence of frailty among patients receiving mechanical ventilation is associated with increased odds of hospital mortality, discharge to long-term care, extubation failure, and need for tracheostomy.

Multicentre pilot randomised clinical trial of early in-bed cycle ergometry with ventilated patients.

Abstract: Introduction Acute rehabilitation in critically ill patients can improve post-intensive care unit (post-ICU) physical function. In-bed cycling early in a patient’s ICU stay is a promising intervention. The objective of this study was to determine the feasibility of recruitment, intervention delivery and retention in a multi centre randomised clinical trial (RCT) of early in-bed cycling with mechanically ventilated (MV) patients. Methods We conducted a pilot RCT conducted in seven Canadian medical-surgical ICUs. We enrolled adults who could ambulate independently before ICU admission, within the first 4 days of invasive MV and first 7 days of ICU admission. Following informed consent, patients underwent concealed randomisation to either 30 min/day of in-bed cycling and routine physiotherapy (Cycling) or routine physiotherapy alone (Routine) for 5 days/week, until ICU discharge. Our feasibility outcome targets included: accrual of 1–2 patients/month/site; >80% cycling protocol delivery; >80% outcomes measured and >80% blinded outcome measures at hospital discharge. We report ascertainment rates for our primary outcome for the main trial (Physical Function ICU Test-scored (PFIT-s) at hospital discharge). Results Between 3/2015 and 6/2016, we randomised 66 patients (36 Cycling, 30 Routine). Our consent rate was 84.6 % (66/78). Patient accrual was (mean (SD)) 1.1 (0.3) patients/month/site. Cycling occurred in 79.3% (146/184) of eligible sessions, with a median (IQR) session duration of 30.5 (30.0, 30.7) min. We recorded 43 (97.7%) PFIT-s scores at hospital discharge and 37 (86.0%) of these assessments were blinded. Discussion Our pilot RCT suggests that a future multicentre RCT of early in-bed cycling for MV patients in the ICU is feasible. Trial registration number NCT02377830.

Improving End-of-Life Care in the Intensive Care Unit: Clinicians' Experiences with the 3 Wishes Project.

Abstract: Background: End-of-life (EOL) care is an important aspect of practice in the intensive care unit (ICU), where approximately one of every five patients may die. Objective: The objective of this study was to describe clinicians' experiences with the 3 Wishes Project (3WP) and understand the influence of the project on care in the ICU. Design: The 3WP is a palliative care intervention in which clinicians elicit and implement final wishes for patients dying in the ICU; it had been implemented for seven months at the time of this study. This mixed-methods study includes quantitative data from clinician surveys and qualitative data from clinician focus groups. Setting: A 24-bed medical ICU in a tertiary academic center. Subjects: Perspectives of 97 clinicians working in the ICU during the study period were obtained by self-administered surveys. Five focus groups with 25 nurses and 5 physicians were held, digitally recorded, transcribed, and analyzed. Measurements and Results: During the 7-month period, 67 decedents and their families participated in the 3WP. The overarching concept identified through analysis of the survey and focus group data is that the 3WP improves EOL care in the ICU, which was supported by three main themes: (1) The 3WP facilitates meaningful EOL care; (2) The 3WP has a positive impact on nurses and physicians; and (3) clinicians observe a positive influence of the 3WP on families. Conclusions: This patient-centered and family-partnered intervention facilitates meaningful EOL care, favorably impacting the ICU team and positively influencing family members.

A multicentre controlled pre-post trial of an implementation science intervention to improve venous thromboembolism prophylaxis in critically ill patients.

Abstract: To test whether a multicomponent intervention would increase the use of low molecular weight heparin (LMWH) over unfractionated heparin (UFH) for venous thromboembolism (VTE) prophylaxis in critically ill patients and change patient outcomes and healthcare utilization. Controlled pre–post trial of 12,342 adults admitted to 11 ICUs (five intervention, six control) May 1, 2015 to April 30, 2017 with no contraindication to pharmacological prophylaxis and an ICU stay longer than 24 h. Models were developed to examine temporal changes in ICU VTE prophylaxis (primary outcome), VTE, major bleeding, heparin-induced thrombocytopenia (HIT), death and hospital costs. The use of LMWH increased from 45.9% to 78.3% of patient days in the intervention group and from 37.9% to 53.3% in the control group, an absolute increase difference of 17.0% (32.4% vs. 15.4%, p = 0.001). Changes in the administration of UFH were inversely related to those of LMWH. There were no significant differences in the adjusted odds of VTE (ratio of odds ratios [rOR] 1.13, 95% CI 0.51–2.46) or major bleeding (rOR 1.22, 95% CI 0.97–1.54) post-implementation of the intervention (compared to pre-implementation) between the intervention group and the control group. HIT was uncommon in both groups (n = 20 patients). There were no significant changes for ICU and hospital mortality, length of stay and costs. Results were similar when stratified according to reason for ICU admission, patient weight and kidney function. A multicomponent intervention changed practice, but not clinical and economic outcomes. The benefit of implementing LMWH for VTE prophylaxis under real-world conditions is uncertain.

Evaluating probiotics for the prevention of ventilator-associated pneumonia: a randomised placebo-controlled multicentre trial protocol and statistical analysis plan for PROSPECT.

Abstract: Introduction Ventilator-associated pneumonia (VAP) is the most common healthcare-associated infection in critically ill patients. Prior studies suggest that probiotics may reduce VAP and other infections in critically ill patients; however, most previous randomised trials were small, single centre studies. The Probiotics: Prevention of Severe Pneumonia and Endotracheal Colonization Trial (PROSPECT) aims to determine the impact of the probiotic Lactobacillus rhamnosus GG on VAP and other clinically important outcomes in critically ill adults. Methods PROSPECT is a multicentre, concealed, randomised, stratified, blinded, controlled trial in patients ≥18 years old, anticipated to be mechanically ventilated ≥72 hours, in intensive care units (ICUs) in Canada, the USA and Saudi Arabia. Patients receive either 1×1010 colony forming units of L. rhamnosus GG twice daily or an identical appearing placebo. Those at increased risk of probiotic infection are excluded. The primary outcome is VAP. Secondary outcomes are other ICU-acquired infections including Clostridioides difficile infection, diarrhoea (including antibiotic-associated diarrhoea), antimicrobial use, ICU and hospital length of stay and mortality. The planned sample size of 2650 patients is based on an estimated 15% VAP rate and will provide 80% power to detect a 25% relative risk reduction. Ethics and dissemination This protocol and statistical analysis plan outlines the methodology, primary and secondary analyses, sensitivity analyses and subgroup analyses. PROSPECT is approved by Health Canada (#9427-M1133-45C), the research ethics boards of all participating hospitals and Public Health Ontario. Results will be disseminated via academic channels (peer reviewed journal publications, professional healthcare fora including international conferences) and conventional and social media. The results of PROSPECT will inform practice guidelines worldwide. Trialregistration number NCT02462590; Pre-results.

Barriers and facilitators to adopting high value practices and de-adopting low value practices in Canadian intensive care units: a multimethod study.

Abstract: Objective To compare and contrast illustrative examples of the adoption of high value practices and the de-adoption of low value practices. Design (1) Retrospective, population-based audit of low molecular weight heparin (LMWH) for venous thromboembolism (VTE) prophylaxis (high value practice) and albumin for fluid resuscitation (low value practice) and (2) cross-sectional survey of healthcare providers. Setting Data were collected from nine adult medical-surgical intensive care units (ICUs) in two large Canadian cities. Patients are managed in these ICUs by a group of multiprofessional and multidisciplinary healthcare providers. Participants Participants included 6946 ICU admissions and 309 healthcare providers from the same ICUs. Main outcome measures (1) The use of LMWH for VTE prophylaxis (per cent ICU days) and albumin for fluid resuscitation (per cent of patients); and (2) provider knowledge of evidence underpinning these practices, and barriers and facilitators to adopt and de-adopt these practices. Results LMWH was administered on 38.7% of ICU days, and 20.0% of patients received albumin. Most participants had knowledge of evidence underpinning VTE prophylaxis and fluid resuscitation (59.1% and 84.2%, respectively). Providers perceived these practices to be followed. The most commonly reported barrier to adoption was insufficient knowledge/understanding (32.8%), and to de-adoption was clinical leader preferences (33.2%). On-site education was the most commonly identified facilitator for adoption and de-adoption (67.8% and 68.6%, respectively). Conclusions Despite knowledge of and self-reported adherence to best practices, the audit demonstrated opportunity to improve. Provider-reported barriers and facilitators to adoption and de-adoption are broadly similar.

Diarrhoea: interventions, consequences and epidemiology in the intensive care unit (DICE-ICU): a protocol for a prospective multicentre cohort study.

Abstract: Introduction Diarrhoea is a frequent concern in the intensive care unit (ICU) and is associated with prolonged mechanical ventilation, increased length of ICU stay, skin breakdown and renal dysfunction. However, its prevalence, aetiology and prognosis in the critically ill have been poorly studied. The primary objectives of this study are to determine the incidence, risk factors and consequences of diarrhoea in critically ill adults. The secondary objectives are to estimate the incidence of Clostridium difficile-associated diarrhoea (CDAD) in ICU patients and to validate the Bristol Stool Chart and Bliss Stool Classification System characterising bowel movements in the ICU. Our primary outcome is the incidence of diarrhoea . Our secondary outcomes include: CDAD, ICU and hospital mortality and ICU and hospital length of stay. Methods and analysis This international prospective cohort study will enrol patients over 10 weeks in 12 ICUs in Canada, the USA, Poland and Saudi Arabia. We will include all patients 18 years of age and older who are admitted to the ICU for at least 24 hours and follow them daily until ICU discharge. Our primary outcome is the incidence of diarrhoea based on the WHO definition, during the ICU stay. Our secondary outcomes include: CDAD, ICU and hospital mortality and ICU and hospital length of stay. We will use logistic regression to identify factors associated with diarrhoea (as defined using WHO criteria) and the kappa statistic to measure agreement on diarrhoea rates between the WHO definition and the Bristol Stool Chart and Bliss Stool Classification System. Ethics and dissemination The protocol has been approved by the research ethics board of all participating centres. The diarrhoea interventions, consequences and epidemiology in the intensive care unit (DICE-ICU) study will generate evidence about diarrhoea and its frequency, predisposing factors and consequences, to inform critical care practice and future research. Lay summary Diarrhoea is a frequent clinical problem for hospitalised patients including those who are critically ill in the ICU. Diarrhoea can cause complications such as skin damage, dehydration and kidney problems. It is not clear how common diarrhoea is in the ICU, the factors that cause it or the best way for clinicians to assess it. The DICE-ICU study is an international prospective observational study to examine the frequency, risk factors and outcomes of diarrhoea during critical illness.

Mortality Risk Profiles for Sepsis: A Novel Longitudinal and Multivariable Approach.

Abstract: To determine if a set of time-varying biological indicators can be used to: 1) predict the sepsis mortality risk over time and 2) generate mortality risk profiles. Design Prospective observational study. Setting Nine Canadian ICUs. Subjects Three-hundred fifty-six septic patients. Interventions None. Measurements and main results Clinical data and plasma levels of biomarkers were collected longitudinally. We used a complementary log-log model to account for the daily mortality risk of each patient until death in ICU/hospital, discharge, or 28 days after admission. The model, which is a versatile version of the Cox model for gaining longitudinal insights, created a composite indicator (the daily hazard of dying) from the "day 1" and "change" variables of six time-varying biological indicators (cell-free DNA, protein C, platelet count, creatinine, Glasgow Coma Scale score, and lactate) and a set of contextual variables (age, presence of chronic lung disease or previous brain injury, and duration of stay), achieving a high predictive power (conventional area under the curve, 0.90; 95% CI, 0.86-0.94). Including change variables avoided misleading inferences about the effects of day 1 variables, signifying the importance of the longitudinal approach. We then generated mortality risk profiles that highlight the relative contributions among the time-varying biological indicators to overall mortality risk. The tool was validated in 28 nonseptic patients from the same ICUs who became septic later and was subject to 10-fold cross-validation, achieving similarly high area under the curve. Conclusions Using a novel version of the Cox model, we created a prognostic tool for septic patients that yields not only a predicted probability of dying but also a mortality risk profile that reveals how six time-varying biological indicators differentially and longitudinally account for the patient's overall daily mortality risk.

Frequency of Screening for Weaning From Mechanical Ventilation: Two Contemporaneous Proof-of-Principle Randomized Controlled Trials.

Abstract: Objectives It is unknown whether more frequent screening of invasively ventilated patients, identifies patients earlier for a spontaneous breathing trial, and shortens the duration of ventilation. We assessed the feasibility of conducting a large trial to evaluate screening frequency in critically ill adults in the North American context. Design We conducted two contemporaneous, multicenter, pilot, randomized controlled trials (the LibeRation from MEchanicaL VEntilAtion and ScrEening Frequency [RELEASE] and Screening Elderly PatieNts For InclusiOn in a Weaning [SENIOR] trials) to address concerns regarding the potential for higher enrollment, fewer adverse events, and better outcomes in younger patients. Setting Ten and 11 ICUs in Canada, respectively. Patients Parallel trials of younger (RELEASE Interventions Each trial compared once daily screening to "at least twice daily" screening led by respiratory therapists. Measurements and main results In both trials, we evaluated recruitment (aim: 1-2 patients/month/ICU) and consent rates, reasons for trial exclusion, protocol adherence (target: ≥ 80%), crossovers (aim: ≤ 10%), and the effect of the alternative screening frequencies on adverse events and clinical outcomes. We included 155 patients (53 patients [23 once daily, 30 at least twice daily] in RELEASE and 102 patients [54 once daily, 48 at least twice daily] in SENIOR). Between trials, we found similar recruitment rates (1.32 and 1.26 patients/month/ICU) and reasons for trial exclusion, high consent and protocol adherence rates (> 92%), infrequent crossovers, and few adverse events. Although underpowered, at least twice daily screening was associated with a nonsignificantly faster time to successful extubation and more successful extubations but significantly increased use of noninvasive ventilation in both trials combined. Conclusions Similar recruitment and consent rates, few adverse events, and comparable outcomes in younger and older patients support conduct of a single large trial in North American ICUs assessing the net clinical benefits associated with more frequent screening.

Project management lessons learned from the multicentre CYCLE pilot randomized controlled trial

Abstract: Clinical trials management can be studied using project management theory. The CYCLE pilot randomized controlled trial (RCT) was conducted to determine the feasibility of a future rehabilitation trial of early in-bed cycling in the intensive care unit (ICU). In-bed cycling is a novel intervention, not typically available in ICUs. Implementation of this intervention requires personnel with specialized clinical expertise caring for critically ill patients and use of the in-bed cycle. Our objective was to describe the implementation and conduct of our pilot RCT using a project management approach. We retrospectively reviewed activities, timelines, and personnel involved in the trial. We organized activities into four project management phases: initiation, planning, execution, and monitoring and controlling. Data sources included Methods Centre documents used for trial coordination and conduct, and the trial data set. We report descriptive statistics as counts and proportions and also medians and quartiles, and we summarize the lessons learned. Seven ICUs in Canada participated in the trial. Time from research ethics board and contracts submission to first enrolment was a median (first quartile, third quartile) of 185 (146, 209) and 162 (114, 181) days, respectively. We trained 128 personnel on the CYCLE pilot RCT protocol, and 80 (63%) completed trial-related activities. Four sites required additional training after start-up due to staff turnover and leaves of absence. Over 15 months, we screened 864 patients: 256 were eligible and 66 were enrolled. Despite an 85% consent rate, 74% (190/256) of eligible patients were not randomized, largely (80% [152/190]) due to physiotherapist availability. Thirteen percent of recruitment weeks were lost due to physiotherapist staffing shortages. We highlight five key lessons learned: (1) prepare and anticipate site needs; (2) communicate regularly; (3) proactively analyse and act on process measure data; (4) develop contingency plans; (5) express appreciation to participating sites. Our analysis highlights the scope of relevant activities, rigorous training and monitoring, number and types of required personnel, and time required to conduct a multicentre ICU rehabilitation intervention trial. Our lessons learned can help others interested in implementing complex intervention trials, such as rehabilitation. ClinicalTrials.gov, NCT02377830. Registered prospectively on 4 March 2015.

A mixed-methods study of organ donation in the intensive care unit: 22 actionable practices to improve organ donation.

Abstract: Rates of organ donation vary between otherwise comparable intensive care units (ICUs) suggesting that the process of donation must vary between ICUs. The purpose of this study was to describe the process of organ donation from the perspective of ICU staff, identify important drivers of successful donation, and develop strategies to improve the process of donation. We conducted qualitative interviews with 32 ICU staff, including physicians, nurses, and respiratory therapists, using an interview guide developed from previous studies on organ donation. Using a qualitative descriptive approach, we coded interviews using qualitative content analysis. We integrated findings from the interviews in a mixed-methods analysis with previously published data from a document analysis and cross-sectional survey to identify practices that may enhance organ donation in the ICU. Five major themes important to the organ donation process emerged from the interviews: i) staff relationship with organ donation coordinators; ii) standardized processes; iii) ICU staff beliefs; iv) integration of donation and high quality end-of-life care; v) feedback and staff support. In the mixed-methods analysis, we identified 22 actionable practices to enhance the process of organ donation in the ICU. Incorporating the perspectives of ICU staff, we were able to identify 22 practice changes that may have a significant cumulative impact on donation outcomes. Future research is required to evaluate whether these findings account for the variability of donation rates between otherwise comparable ICUs.

Definitions of post-coronary artery bypass grafting myocardial infarction: variations in incidence and prognostic significance.

Abstract: OBJECTIVES Using data from the CORONARY trial (n = 4752), we evaluated the incidence and prognostic significance of myocardial infarction (MI) applying different definitions based on peak postoperative creatine kinase-MB isoenzyme and cardiac troponin levels. We then aimed to identify the peak cardiac troponin during the first 3 postoperative days that was independently associated with a 2-fold increase in 30-day mortality. METHODS To combine different assays, we analysed cardiac troponins in multiples of their respective upper limit of normal (ULN). We identified the lowest threshold with a hazard ratio (HR) >2 for 30-day mortality independent of EuroSCORE and on- versus off-pump surgery. RESULTS Depending on the definition used based on creatine kinase-MB, the incidence of MI after coronary artery bypass grafting (CABG) ranged from 0.6% to 19% and the associated HRs for 30-day mortality ranged from 2.7 to 6.9. Using cardiac troponin (1528 patients), the incidence of MI ranged from 1.7% to 13% depending on the definition used with HRs for 30-day mortality ranging from 5.1 to 7.2. The first cardiac troponin threshold we evaluated, 180xULN, was associated with an adjusted HR for 30-day mortality of 7.6 [95% confidence interval (CI) 3.4-17.1] when compared to <130xULN. The next independent threshold was 130xULN with an adjusted HR for 30-day mortality of 7.8 (95% CI 2.3-26.1). The next cardiac troponin tested threshold (70xULN) did not meet criteria for significance. CONCLUSIONS Our results illustrate that the incidence and prognosis of a post-CABG MI varies based on the definition used. Validated post-CABG MI diagnostic criteria formulated from their independent association with important clinical outcomes are needed.

A Multidisciplinary Survey to Assess Facilitators and Barriers to Successful Organ Donation in the Intensive Care Unit

Abstract: Introduction:Rates of successful organ donation vary between otherwise comparable intensive care units (ICUs). The ICU staff have a unique perspective into the facilitators and barriers underlying ...

A Device on Trial — Intermittent Pneumatic Compression in Critical Care

Abstract: The intensive care unit (ICU) is replete with devices used for monitoring, prevention, diagnosis, treatment, and rehabilitation in critically ill patients. The approval process for high-risk medica...

Variation in the practice of discontinuing mechanical ventilation in critically ill adults: study protocol for an international prospective observational study.

Abstract: Introduction Research supports the use of specific strategies to discontinue mechanical ventilation (MV) in critically ill patients. Little is known about how clinicians actually wean and discontinue MV in practice or the association between different discontinuation strategies and outcomes. The primary objective of this study is to describe international practices in the use of (1) daily screening for readiness to discontinue MV, (2) modes of MV used before initial discontinuation attempts, (3) weaning and spontaneous breathing trial (SBT) protocols, (4) SBT techniques and (5) sedation and mobilisation practices to facilitate weaning and discontinuation. The secondary objectives are to identify patient characteristics and time-dependent factors associated with use of selected strategies, investigate associations between SBT outcome (failure vs success) and outcomes, explore differences between patients who undergo an SBT early versus later in their intensive care unit (ICU) stay, and investigate the associations between different SBT techniques and humidification strategies on outcomes. Methods and analysis We will conduct an international, prospective, observational study of MV discontinuation practices among critically ill adults who receive invasive MV for at least 24 hours at approximately 150 ICUs in six geographic regions (Canada, USA, UK, Europe, India and Australia/New Zealand). Research personnel at participating ICUs will collect demographic data, data to characterise the initial strategy or event that facilitated discontinuation of MV (direct extubation, direct tracheostomy, initial successful SBT, initial failed SBT or death before any attempt could be made), clinical outcomes and site information. We aim to collect data on at least 10 non-death discontinuation events in each ICU (at least 1500 non-death discontinuation events). Ethics and dissemination This study received Research Ethics Approval from St. Michael’s Hospital (11-024) Research ethics approval will be sought from all participating sites. The results will be disseminated through publications in peer-reviewed journals. Trial registration number NCT03955874.

Frequency of Screening and SBT Technique Trial - North American Weaning Collaboration (FAST-NAWC): a protocol for a multicenter, factorial randomized trial

Abstract: In critically ill patients receiving invasive mechanical ventilation (MV), research supports the use of daily screening to identify patients who are ready to undergo a spontaneous breathing trial (SBT) followed by conduct of an SBT. However, once daily (OD) screening is poorly aligned with the continuous care provided in most intensive care units (ICUs) and the best SBT technique for clinicians to use remains controversial. To identify the optimal screening frequency and SBT technique to wean critically ill adults in the ICU. We aim to conduct a multicenter, factorial design randomized controlled trial with concealed allocation, comparing the effect of both screening frequency (once versus at least twice daily [ALTD]) and SBT technique (Pressure Support [PS] + Positive End-Expiratory Pressure [PEEP] vs T-piece) on the time to successful extubation (primary outcome) in 760 critically ill adults who are invasively ventilated for at least 24 h in 20 North American ICUs. In the OD arm, respiratory therapists (RTs) will screen study patients between 06:00 and 08:00 h. In the ALTD arm, patients will be screened at least twice daily between 06:00 and 08:00 h and between 13:00 and 15:00 h with additional screens permitted at the clinician’s discretion. When the SBT screen is passed, an SBT will be conducted using the assigned technique (PS + PEEP or T-piece). We will follow patients until successful extubation, death, ICU discharge, or until day 60 after randomization. We will contact patients or their surrogates six months after randomization to assess health-related quality of life and functional status. The around-the-clock availability of RTs in North American ICUs presents an important opportunity to identify the optimal SBT screening frequency and SBT technique to minimize patients’ exposure to invasive ventilation and ventilator-related complications. Clinical Trials.gov, NCT02399267 . Registered on Nov 21, 2016 first registered.

Fostering humanism: a mixed methods evaluation of the Footprints Project in critical care.

Abstract: Objectives The objectives of this mixed-methods study were to assess the uptake, sustainability and influence of the Footprints Project. Setting Twenty-two-bed university-affiliated ICU in Hamilton, Canada. Participants ICU patients admitted and their families, as well as clinicians. Interventions We developed a personalised patient Footprints Form and Whiteboard to facilitate holistic, patient-centred care, to inform clinical encounters, and to create deeper connections among patients, families and clinicians. Outcome measures We conducted 3 audits to examine uptake and sustainability. We conducted semi-structured interviews with 10 clinicians, and held 5 focus groups with 25 clinicians; and we interviewed 5 patients and 13 family representatives of 5 patients who survived and 5 who died in the ICU. Transcripts were analysed using qualitative content analysis. Results The Footprints Project facilitated holistic, patient-centred care by setting the stage for patient and family experience, motivating the patient and humanising the patient for clinicians. Through informing clinical encounters, Footprints helped clinicians initiate more personal conversations, foster deeper connections and guide treatment. Professional practice influences included more focused attention on the patient, enhanced interdisciplinary communication and changes in community culture. Initially used in 15.8% of patients (audit A), uptake increased to 51.4% in audit B, and was sustained at 57.8% in audit C. Conclusions By sharing valuable personal information about patients before and beyond their illness on individualised whiteboards at each bedside, the Footprints Project fosters humanism in critical care practice.

Correction to: Project management lessons learned from the multicentre CYCLE pilot randomized controlled trial.

Abstract: Following publication of the original article [1], we have been notified that one of the authors’ names is spelled incorrectly. In this Correction the incorrect and correct author name are shown.

The PROTROPIC feasibility study: prognostic value of elevated troponins in critical illness

Abstract: Elevated cardiac troponin concentrations in people with critical illness are associated with an increased risk of death. We aimed to assess the feasibility of a larger study to ascertain the utility of cardiac troponin as a prognostic tool for mortality in critically ill patients. Patients admitted to participating intensive care units during the one-month enrolment period were eligible. We excluded cardiac surgical patients and patients who were admitted and either died or were discharged within 12 hr. In enrolled patients, we measured high-sensitivity cardiac troponin I (hs-cTnI) and obtained electrocardiograms to ascertain the incidence of myocardial infarction (MI) and isolated troponin elevation. Our feasibility objectives were to measure recruitment rate, the proportion of patients who consented under a deferred consent model, and time required for data collection and study procedures. Over a four-week enrolment period, 280 patients were enrolled using a deferred consent model. We obtained subsequent consent from 81% of patients. Study procedures and data collection required 1.7 hr per participant. Overall, 86 (38%) suffered a MI, 23 (10%) had an isolated hs-cTnI elevation, and 117 (52%) had no hs-cTnI elevation. The crude hospital mortality rate was 10% without an hs-cTnI elevation, 29% with an isolated hs-cTnl elevation (relative risk [RR]) 2.2; 95% confidence interval [CI], 1.0 to 6.0) and 29% with an MI (RR, 2.6; 95% CI, 1.4 to 5.1). Myocardial injury with elevated hs-cTnI concentrations and MIs occur frequently during critical illness. This pilot study has established the feasibility of conducting a large-scale investigation addressing this issue.