Effect of Flexible Family Visitation on Delirium Among Patients in the Intensive Care Unit: The ICU Visits Randomized Clinical Trial.

Importance: The effects of intensive care unit (ICU) visiting hours remain uncertain. Objective: To determine whether a flexible family visitation policy in the ICU reduces the incidence of delirium. Design, Setting and Participants: Cluster-crossover randomized clinical trial involving patients, family members, and clinicians from 36 adult ICUs with restricted visiting hours (<4.5 hours per day) in Brazil. Participants were recruited from April 2017 to June 2018, with follow-up until July 2018. Interventions: Flexible visitation (up to 12 hours per day) supported by family education (n = 837 patients, 652 family members, and 435 clinicians) or usual restricted visitation (median, 1.5 hours per day; n = 848 patients, 643 family members, and 391 clinicians). Nineteen ICUs started with flexible visitation, and 17 started with restricted visitation. Main Outcomes and Measures: Primary outcome was incidence of delirium during ICU stay, assessed using the CAM-ICU. Secondary outcomes included ICU-acquired infections for patients; symptoms of anxiety and depression assessed using the HADS (range, 0 [best] to 21 [worst]) for family members; and burnout for ICU staff (Maslach Burnout Inventory). Results: Among 1685 patients, 1295 family members, and 826 clinicians enrolled, 1685 patients (100%) (mean age, 58.5 years; 47.2% women), 1060 family members (81.8%) (mean age, 45.2 years; 70.3% women), and 737 clinicians (89.2%) (mean age, 35.5 years; 72.9% women) completed the trial. The mean daily duration of visits was significantly higher with flexible visitation (4.8 vs 1.4 hours; adjusted difference, 3.4 hours [95% CI, 2.8 to 3.9]; P < .001). The incidence of delirium during ICU stay was not significantly different between flexible and restricted visitation (18.9% vs 20.1%; adjusted difference, -1.7% [95% CI, -6.1% to 2.7%]; P = .44). Among 9 prespecified secondary outcomes, 6 did not differ significantly between flexible and restricted visitation, including ICU-acquired infections (3.7% vs 4.5%; adjusted difference, -0.8% [95% CI, -2.1% to 1.0%]; P = .38) and staff burnout (22.0% vs 24.8%; adjusted difference, -3.8% [95% CI, -4.8% to 12.5%]; P = .36). For family members, median anxiety (6.0 vs 7.0; adjusted difference, -1.6 [95% CI, -2.3 to -0.9]; P < .001) and depression scores (4.0 vs 5.0; adjusted difference, -1.2 [95% CI, -2.0 to -0.4]; P = .003) were significantly better with flexible visitation. Conclusions and Relevance: Among patients in the ICU, a flexible family visitation policy, vs standard restricted visiting hours, did not significantly reduce the incidence of delirium. Trial Registration: ClinicalTrials.gov Identifier: NCT02932358.

Statistical analysis plan for a cluster-randomized crossover trial comparing the effectiveness and safety of a flexible family visitation model for delirium prevention in adult intensive care units (the ICU Visits Study).

BACKGROUND: Most adult intensive care units (ICUs) worldwide adopt restrictive family visitation models (RFVMs). However, evidence, mostly from non-randomized studies, suggests that flexible adult ICU visiting hours are safe policies that can result in benefits such as prevention of delirium and increase in satisfaction with care. Accordingly, the ICU Visits Study was designed to compare the effectiveness and safety of a flexible family visitation model (FFVM) vs. an RFVM on delirium prevention among ICU patients, and also to analyze its potential effects on family members and ICU professionals. METHODS/DESIGN: The ICU Visits Study is a cluster-randomized crossover trial which compares an FFVM (12 consecutive ICU visiting hours per day) with an RFVM (< 4.5 ICU visiting hours per day) in 40 Brazilian adult ICUs. Participant ICUs are randomly assigned to either an FFVM or RFVM in a 1:1 ratio. After enrollment and follow-up of 25 patients, each ICU is crossed over to the other visitation model, until 25 more patients per site are enrolled and followed. The primary outcome is the cumulative incidence of delirium measured by the Confusion Assessment Method for the ICU. Secondary and tertiary outcomes include relevant measures of effectiveness and safety of ICU visiting policies among patients, family members, and ICU professionals. Herein, we describe all primary statistical procedures that will be used to evaluate the results and perform exploratory and sensitivity analyses of this study. This pre-specified statistical analysis plan was written and submitted without knowledge of the study data. DISCUSSION: This a priori statistical analysis plan aims to enhance the transparency of our study, facilitating unbiased analyses of ICU visit study data, and provide guidance for statistical analysis for groups conducting studies in the same field. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02932358 . Registered on 11 October 2016.

A cluster randomized trial of a multifaceted quality improvement intervention in Brazilian intensive care units: study protocol.

BACKGROUND: The uptake of evidence-based therapies in the intensive care environment is suboptimal, particularly in limited-resource countries. Checklists, daily goal assessments, and clinician prompts may improve compliance with best practice processes of care and, in turn, improve clinical outcomes. However, the available evidence on the effectiveness of checklists is unreliable and inconclusive, and the mechanisms are poorly understood. We aim to evaluate whether the use of a multifaceted quality improvement intervention, including the use of a checklist and the definition of daily care goals during multidisciplinary daily rounds and clinician prompts, can improve the in-hospital mortality of patients admitted to intensive care units (ICUs). Our secondary objectives are to assess the effects of the study intervention on specific processes of care, clinical outcomes, and the safety culture and to determine which factors (the processes of care and/or safety culture) mediate the effect of the study intervention on mortality. METHODS/DESIGN: This is a cluster randomized trial involving 118 ICUs in Brazil conducted in two phases. In the observational preparatory phase, we collect baseline data on processes of care and clinical outcomes from 60 consecutive patients with lengths of ICU stay longer than 48 h and apply the Safety Attitudes Questionnaire (SAQ) to 75% or more of the health care staff in each ICU. In the randomized phase, we assign ICUs to the experimental or control arm and repeat data collection. Experimental arm ICUs receive the multifaceted quality improvement intervention, including a checklist and definition of daily care goals during daily multidisciplinary rounds, clinician prompting, and feedback on rates of adherence to selected care processes. Control arm ICUs maintain usual care. The primary outcome is in-hospital mortality, truncated at 60 days. Secondary outcomes include the rates of adherence to appropriate care processes, rates of other clinical outcomes, and scores on the SAQ domains. Analysis follows the intention-to-treat principle, and the primary outcome is analyzed using mixed effects logistic regression. DISCUSSION: This is a large scale, pragmatic cluster-randomized trial evaluating whether a multifaceted quality improvement intervention, including checklists applied during the multidisciplinary daily rounds and clinician prompting, can improve the adoption of proven therapies and decrease the mortality of critically ill patients. If this study finds that the intervention reduces mortality, it may be widely adopted in intensive care units, even those in limited-resource settings. TRIAL REGISTRATION: ClinicalTrials.gov NCT01785966.

Central venous saturation is a predictor of reintubation in difficult-to-wean patients.

OBJECTIVE: To evaluate the predictive value of central venous saturation to detect extubation failure in difficult-to-wean patients. DESIGN: Cohort, multicentric, clinical study. SETTING: Three medical-surgical intensive care units. PATIENTS: All difficult-to-wean patients (defined as failure to tolerate the first 2-hr T-tube trial), mechanically ventilated for >48 hrs, were extubated after undergoing a two-step weaning protocol (measurements of predictors followed by a T-tube trial). Extubation failure was defined as the need of reintubation within 48 hrs. INTERVENTIONS: The weaning protocol evaluated hemodynamic and ventilation parameters, and arterial and venous gases during mechanical ventilation (immediately before T-tube trial), and at the 30th min of spontaneous breathing trial. MEASUREMENTS AND MAIN RESULTS: Seventy-three patients were enrolled in the study over a 6-mo period. Reintubation rate was 42.5%. Analysis by logistic regression revealed that central venous saturation was the only variable able to discriminate outcome of extubation. Reduction of central venous saturation by >4.5% was an independent predictor of reintubation, with odds ratio of 49.4 (95% confidence interval 12.1-201.5), a sensitivity of 88%, and a specificity of 95%. Reduction of central venous saturation during spontaneous breathing trial was associated with extubation failure and could reflect the increase of respiratory muscles oxygen consumption. CONCLUSIONS: Central venous saturation was an early and independent predictor of extubation failure and may be a valuable accurate parameter to be included in weaning protocols of difficult-to-wean patients.

Partial liquid ventilation with perfluorodecalin following unilateral canine lung allotransplantation in non-heart-beating donors.

BACKGROUND: The purpose of this study was to evaluate canine lungs obtained from non-heart-beating donors after unilateral lung transplantation subjected to partial liquid ventilation with perfluorodecalin. METHODS: Twelve donor dogs were killed and kept under mechanical ventilation for 3 hours. Heart-lung blocks were harvested after retrograde pulmonary hypothermic flush with Perfadex. Left lung grafts were randomly transplanted into 12 weight-matched recipient animals. Animals were divided into 2 groups: control (standard mechanical ventilation, n = 6) and PLV (partial liquid ventilation, n = 6). Forty-five minutes after transplantation, the animals in the PLV group received perfluorodecalin (15 ml/kg) via orotracheal tube. All animals received volume-controlled ventilation (FIO2) 1.0, PEEP 5 cm H(2)O) over 6 consecutive hours. Thereafter, blood-gas analysis, ventilatory mechanics and hemodynamics were registered at 30-minute intervals. After 6 hours of reperfusion the animals were killed and the transplanted lungs were extracted to obtain the wet/dry weight ratio. RESULTS: There were significant differences in pulmonary arterial pressure, which were higher in control group animals (p < 0.009). The control animals also showed higher arterial PaO(2) than those in the PLV group (p < 0.00001), but lower PaCO(2) (p < 0.008). The peak and plateau pressures were higher in the PLV group (p < 0.00001). Neither static compliance nor wet/dry weight ratios were different in between groups. CONCLUSIONS: PLV with perfluorodecalin yields functional results compatible with life in this model. Nonetheless, pulmonary gas exchange and mechanics were superior after reperfusion in animals given conventional mechanical ventilation up to 6 hours after left lung allotransplantation.