Feasibility of implementing Extubation Advisor, a clinical decision support tool to improve extubation decision-making in the ICU: a mixed-methods observational study.

OBJECTIVES: Although spontaneous breathing trials (SBTs) are standard of care to extubation readiness, no tool exists that optimises prediction and standardises assessment. In this study, we evaluated the feasibility and clinical impressions of Extubation Advisor (EA), a comprehensive clinical extubation decision support (CDS) tool. DESIGN: Phase I mixed-methods observational study. SETTING: Two Canadian intensive care units (ICUs). PARTICIPANTS: We included patients on mechanical ventilation for ≥24 hours and clinicians (respiratory therapists and intensivists) responsible for extubation decisions. INTERVENTIONS: Components included a predictive model assessment, feasibility evaluation, questionnaires and interviews with clinicians. RESULTS: We enrolled 117 patients, totalling 151 SBTs and 80 extubations. The incidence of extubation failure was 11% in low-risk patients and 21% in high-risk patients stratified by the predictive model; 38% failed extubation when both the model and clinical impression were at high risk. The tool was well rated: 94% and 75% rated the data entry and EA report as average or better, respectively. Interviews (n=15) revealed favourable impressions regarding its user interface and functionality, but unexpectedly, also concerns regarding EA's potential impact on respiratory therapists' job security. CONCLUSIONS: EA implementation was feasible, and users perceived it to have potential to support extubation decision-making. This study helps to understand bedside implementation of CDS tools in a multidisciplinary ICU. TRIAL REGISTRATION NUMBER: NCT02988167.

Risk of dispersion or aerosol generation and infection transmission with nasopharyngeal and oropharyngeal swabs for detection of COVID-19: a systematic review.

OBJECTIVES: SARS-CoV-2-related disease, referred to as COVID-19, has emerged as a global pandemic since December 2019. While there is growing recognition regarding possible airborne transmission, particularly in the setting of aerosol-generating procedures and treatments, whether nasopharyngeal and oropharyngeal swabs for SARS-CoV-2 generate aerosols remains unclear. DESIGN: Systematic review. DATA SOURCES: We searched Ovid MEDLINE and EMBASE up to 3 November 2020. We also searched the China National Knowledge Infrastructure, Chinese Medical Journal Network, medRxiv and ClinicalTrials.gov up to 29 March 2020. ELIGIBILITY CRITERIA: All comparative and non-comparative studies that evaluated dispersion or aerosolisation of viable airborne organisms, or transmission of infection associated with nasopharyngeal or oropharyngeal swab testing. RESULTS: Of 7702 citations, only one study was deemed eligible. Using a dedicated sampling room with negative pressure isolation room, personal protective equipment including N95 or higher masks, strict sterilisation protocols, structured training with standardised collection methods and a structured collection and delivery system, a tertiary care hospital proved a 0% healthcare worker infection rate among eight nurses conducting over 11 000 nasopharyngeal swabs. No studies examining transmissibility with other safety protocols, nor any studies quantifying the risk of aerosol generation with nasopharyngeal or oropharyngeal swabs for detection of SARS-CoV-2, were identified. CONCLUSIONS: There is limited to no published data regarding aerosol generation and risk of transmission with nasopharyngeal and oropharyngeal swabs for the detection of SARS-CoV-2. Field experiments to quantify this risk are warranted. Vigilance in adhering to current standards for infection control is suggested.

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

BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02377830 . Registered prospectively on 4 March 2015.

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

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.

Variation in Definition of Prolonged Mechanical Ventilation.

Consistency of definitional criteria for terminology applied to describe subject cohorts receiving mechanical ventilation within ICU and post-acute care settings is important for understanding prevalence, risk stratification, effectiveness of interventions, and projections for resource allocation. Our objective was to quantify the application and definition of terms for prolonged mechanical ventilation. We conducted a scoping review of studies (all designs except single-case study) reporting a study population (adult and pediatric) using the term prolonged mechanical ventilation or a synonym. We screened 5,331 references, reviewed 539 full-text references, and excluded 120. Of the 419 studies (representing 38 countries) meeting inclusion criteria, 297 (71%) reported data on a heterogeneous subject cohort, and 66 (16%) included surgical subjects only (46 of those 66, 70% cardiac surgery). Other studies described COPD (16, 4%), trauma (22, 5%), neuromuscular (17, 4%), and sepsis (1, 0.2%) cohorts. A total of 741 terms were used to refer to the 419 study cohorts. The most common terms were: prolonged mechanical ventilation (253, 60%), admission to specialized unit (107, 26%), and long-term mechanical ventilation (79, 19%). Some authors (282, 67%) defined their cohorts based on duration of mechanical ventilation, with 154 studies (55%) using this as the sole criterion. We identified 37 different durations of ventilation ranging from 5 h to 1 y, with > 21 d being the most common (28 of 282, 7%). For studies describing a surgical cohort, minimum ventilation duration required for inclusion was ≥ 24 h for 20 of 66 studies (30%). More than half of all studies (237, 57%) did not provide a reason/rationale for definitional criteria used, with only 28 studies (7%) referring to a consensus definition. We conclude that substantial variation exists in the terminology and definitional criteria for cohorts of subjects receiving prolonged mechanical ventilation. Standardization of terminology and definitional criteria is required for study data to be maximally informative.

Spontaneous Breathing Trials With T-Piece or Pressure Support Ventilation.

Spontaneous breathing trials (SBTs) are among the most commonly employed techniques to facilitate weaning from mechanical ventilation. The preferred SBT technique, however, is still unclear. To clarify the preferable SBT (T-piece or pressure support ventilation [PSV]), we conducted this systematic review. We then searched the MEDLINE, EMBASE, SciELO, Google Scholar, CINAHL, ClinicalTrials.gov, and Cochrane CENTRAL databases through June 2015, without language restrictions. We included randomized controlled trials involving adult subjects being weaned from mechanical ventilation comparing T-piece with PSV and reporting (1) weaning failure, (2) re-intubation rate, (3) ICU mortality, or (4) weaning duration. Anticipating clinical heterogeneity among the included studies, we compared prespecified subgroups: (1) simple, difficult, or prolonged weaning and (2) subjects with COPD. We summarized the quality of evidence for intervention effects using the GRADE (Grading of Recommendations Assessment, Development, and Evaluation) methodology. We identified 3,674 potentially relevant studies and reviewed 23 papers in full. Twelve studies (2,161 subjects) met our inclusion criteria. Overall, the evidence was of very low to low quality. SBT technique did not influence weaning success (risk ratio 1.23 [0.94-1.61]), ICU mortality (risk ratio 1.11 [0.80-1.54]), or re-intubation rate (risk ratio 1.21 [0.90-1.63]). Prespecified subgroup analysis suggested that PSV might be superior to T-piece with regard to weaning success for simple-to-wean subjects (risk ratio 1.44 [1.11-1.86]). For the prolonged-weaning subgroup, however, T-piece was associated with a shorter weaning duration (weighted mean difference -3.08 [-5.24 to -0.92] d). In conclusion, low-quality evidence is available concerning this topic. PSV may be associated with lower weaning failure rates in the simple-to-wean subgroup. In contrast, in prolonged-weaning subjects, T-piece may be related to a shorter weaning duration, although this is at high risk of bias. Further study of the difficult-to-wean and COPD subgroups is required.

Noninvasive positive pressure ventilation as a weaning strategy for intubated adults with respiratory failure.

BACKGROUND: Noninvasive positive pressure ventilation (NPPV) provides ventilatory support without the need for an invasive airway approach. Interest has emerged in using NPPV to facilitate earlier removal of an endotracheal tube and decrease complications associated with prolonged intubation. OBJECTIVES: To summarize the evidence comparing NPPV and invasive positive pressure ventilation (IPPV) weaning on clinical outcomes in intubated adults with respiratory failure. SEARCH STRATEGY: We searched the Cochrane Central Register of Controlled Trials (The Cochrane Library, Issue 2, 2008), MEDLINE (January 1966 to April 2008), EMBASE (January 1980 to April 2008), proceedings from four conferences, and personal files; and contacted authors to identify randomized controlled trials comparing NPPV and IPPV weaning. SELECTION CRITERIA: Randomized and quasi-randomized studies comparing early extubation with immediate application of NPPV to IPPV weaning in intubated adults with respiratory failure. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed trial quality and abstracted data according to prespecified criteria. Sensitivity and subgroup analyses were planned to assess the impact of (i) excluding quasi-randomized trials, and (ii) the etiology of respiratory failure on selected outcomes. MAIN RESULTS: We identified 12 trials of moderate to good quality that involved 530 participants with predominantly chronic obstructive pulmonary disease (COPD). Compared to the IPPV strategy, NPPV significantly decreased mortality (relative risk (RR) 0.55, 95% confidence Interval (CI) 0.38 to 0.79), ventilator associated pneumonia (RR 0.29, 95% CI 0.19 to 0.45), length of stay in an intensive care unit (weighted mean difference (WMD) -6.27 days, 95% CI -8.77 to -3.78) and hospital (WMD -7.19 days, 95% CI -10.80 to -3.58), total duration of ventilation (WVD) -5.64 days (95% CI -9.50 to -1.77) and duration of endotracheal mechanical ventilation (WMD - 7.81 days, 95% CI -11.31 to -4.31). Noninvasive weaning had no effect on weaning failures or the duration of ventilation related to weaning. Excluding a single quasi-randomized trial maintained the significant reduction in mortality and ventilator associated pneumonia. Subgroup analyses suggested that the benefits on mortality and weaning failures were nonsignificantly greater in trials enrolling exclusively COPD patients versus mixed populations. AUTHORS' CONCLUSIONS: Summary estimates from 12 small studies of moderate to good quality that included predominantly COPD patients demonstrated a consistent, positive effect on mortality and ventilator associated pneumonia. The net clinical benefits associated with noninvasive weaning remain to be fully elucidated.

Protocolized versus non-protocolized weaning for reducing the duration of mechanical ventilation in critically ill adult patients.

BACKGROUND: Reducing weaning time is desirable in minimizing potential complications from mechanical ventilation. Standardized weaning protocols are purported to reduce time spent on mechanical ventilation. However, evidence supporting their use in clinical practice is inconsistent. OBJECTIVES: To assess the effects of protocolized weaning from mechanical ventilation on the total duration of mechanical ventilation for critically ill adults; ascertain differences between protocolized and non-protocolized weaning in terms of mortality, adverse events, quality of life, weaning duration, intensive care unit (ICU) and hospital length of stay (LOS); and explore variation in outcomes by type of ICU, type of protocol and approach to delivering the protocol. SEARCH STRATEGY: We searched the Cochrane Central Register of Controlled Trials (The Cochrane Library Issue 1, 2010), MEDLINE (1950 to 2010), EMBASE (1988 to 2010), CINAHL (1937 to 2010), LILACS (1982 to 2010), ISI Web of Science and ISI Conference Proceedings (1970 to 2010), Cambridge Scientific Abstracts (inception to 2010) and reference lists of articles. We did not apply language restrictions. SELECTION CRITERIA: We included randomized and quasi-randomized controlled trials of protocolized weaning versus non-protocolized weaning from mechanical ventilation in critically ill adults. DATA COLLECTION AND ANALYSIS: Three authors independently assessed trial quality and extracted data. A priori subgroup and sensitivity analyses were performed. We contacted study authors for additional information. MAIN RESULTS: Eleven trials that included 1971 patients met the inclusion criteria. The total duration of mechanical ventilation geometric mean in the protocolized weaning group was on average reduced by 25% compared with the usual care group (N = 10 trials, 95% CI 9% to 39%, P = 0.006); weaning duration was reduced by 78% (N = 6 trials, 95% CI 31% to 93%, P = 0.009); and ICU LOS by 10% (N = 8 trials, 95% CI 2% to 19%, P = 0.02). There was significant heterogeneity among studies for total duration of mechanical ventilation (I(2) = 76%, P < 0.01) and weaning duration (I(2) = 97%, P < 0.01), which could not be explained by subgroup analyses based on type of unit or type of approach. AUTHORS' CONCLUSIONS: There is some evidence of a reduction in the duration of mechanical ventilation, weaning duration and ICU LOS with use of standardized protocols, but there is significant heterogeneity among studies and an insufficient number of studies to investigate the source of this heterogeneity. Although some study authors suggest that organizational context may influence outcomes, these factors were not considered in all included studies and therefore could not be evaluated.

Hypertonic saline for peri-operative fluid management.

BACKGROUND: Fluid excess may place patients undergoing surgery at risk for various complications. Hypertonic saline (HS) maintains intravascular volume with less intravenous fluid than isotonic salt (IS) solutions, but may increase serum sodium. OBJECTIVES: To determine the benefits and harms of HS versus IS solutions administered to patients undergoing surgery. SEARCH STRATEGY: We searched the Cochrane Central Register of Controlled Trials (CENTRAL), (The Cochrane Library) Issue 1, 2009; MEDLINE (1966 to 2009); EMBASE (1980 to 2009); LILACS (to August 2009) and CINAHL (1982 to 2009) without language restrictions. SELECTION CRITERIA: We included randomized clinical trials where HS was compared to IS in patients undergoing surgery, irrespective of blinding, language, and publication status. DATA COLLECTION AND ANALYSIS: We assessed the impact of HS administration on mortality, organ failure, fluid balance, serum sodium, serum osmolarity, diuresis and physiologic measures of cardiovascular function. We pooled data using odds ratio or mean difference (MD) for binary and continuous outcomes, respectively, using random-effects models. MAIN RESULTS: We included 15 studies with 614 participants. One death in each group and no other serious adverse events were reported. While all patients were in a positive fluid balance postoperatively, the excess was significantly less in HS patients (standardized mean difference (SMD) -1.43L, 95% confidence interval (CI) 0.8 to 2.1 L less; P < 0.00001). Patients treated with HS received significantly less fluid than IS-treated patients (MD -2.4L 95% (CI) 1.5 to 3.2 L less; P < 0.00001) without differences in diuresis between the groups. Maximum intraoperative cardiac index was significantly increased with HS (SMD 0.6 L/min/M2 higher, 95% CI 0.1 to 1.0, P = 0.02) but Intraoperative pulmonary artery wedge pressure remained unchanged. While the maximum serum sodium and the serum sodium at the end of the study were significantly higher in HS patients, the level remained within normal limits (136 to 146 meq/L). AUTHORS' CONCLUSIONS: HS reduces the volume of intravenous fluid required to maintain patients undergoing surgery but transiently increases serum sodium. It is not known if HS effects patient survival and morbidity but it should be tested in randomized clinical trials that are designed and powered to test these outcomes.