Spontaneous breathing trial with pressure support on positive end-expiratory pressure and extensive use of non-invasive ventilation versus T-piece in difficult-to-wean patients from mechanical ventilation: a randomized controlled trial.

BACKGROUND: The aim of this study is to assess whether a strategy combining spontaneous breathing trial (SBT) with both pressure support (PS) and positive end-expiratory pressure (PEEP) and extended use of post-extubation non-invasive ventilation (NIV) (extensively-assisted weaning) would shorten the time until successful extubation as compared with SBT with T-piece (TP) and post-extubation NIV performed in selected patients as advocated by guidelines (standard weaning), in difficult-to-wean patients from mechanical ventilation. METHODS: The study is a single-center prospective open label, randomized controlled superiority trial with two parallel groups and balanced randomization with a 1:1 ratio. Eligible patients were intubated patients mechanically ventilated for more than 24 h who failed their first SBT using TP. In the extensively-assisted weaning group, SBT was performed with PS (7 cmH2O) and PEEP (5 cmH2O). In case of SBT success, an additional SBT with TP was performed. Failure of this SBT-TP was an additional criterion for post-extubation NIV in this group in addition to other recommended criteria. In the standard weaning group, SBT was performed with TP, and NIV was performed according to international guidelines. The primary outcome criterion was the time between inclusion and successful extubation evaluated with a Cox model with adjustment on randomization strata. RESULTS: From May 2019 to March 2023, 98 patients were included and randomized in the study (49 in each group). Four patients were excluded from the intention-to-treat population (2 in both groups); therefore, 47 patients were analyzed in each group. The extensively-assisted weaning group had a higher median age (68 [58-73] vs. 62 [55-71] yrs.) and similar sex ratio (62% male vs. 57%). Time until successful extubation was not significantly different between extensively-assisted and standard weaning groups (median, 172 [50-436] vs. 95 [47-232] hours, Cox hazard ratio for successful extubation, 0.88 [95% confidence interval: 0.55-1.42] using the standard weaning group as a reference; p = 0.60). All secondary outcomes were not significantly different between groups. CONCLUSION: An extensively-assisted weaning strategy did not lead to a shorter time to successful extubation than a standard weaning strategy. Trial registration The trial was registered on ClinicalTrials.gov (NCT03861117), on March 1, 2019, before the inclusion of the first patient. https://clinicaltrials.gov/study/NCT03861117 .

The Edmonton Frail Scale Improves the Prediction of 30-Day Mortality in Elderly Patients Undergoing Cardiac Surgery: A Prospective Observational Study.

OBJECTIVES: To investigate whether the Edmonton Frail Scale (EFS), a multidimensional frailty assessment tool, improves the prediction of 30-day or in-hospital mortality over the use of the European System for Cardiac Outcome Risk Evaluation (EuroSCORE) II alone. DESIGN: Single-center prospective observational study. SETTING: University hospital. PARTICIPANTS: Patients aged 75 years or older undergoing cardiac surgery between February 2014 and May 2017. INTERVENTION: No intervention was performed. The EFS was administered the day before surgery. MEASUREMENTS AND MAIN RESULTS: The primary endpoint was 30-day or in-hospital mortality. Secondary endpoints were times to discharge from the intensive care unit (ICU) and from the hospital, discharge to a health care facility, and ability to return home by postoperative day 30. The EFS had a good discriminative ability for 30-day mortality (area under the receiver operating characteristic curve = 0.69; 95% confidence interval [CI], 0.56-0.82). Adding frailty, defined by an EFS ≥8, to the EuroSCORE II significantly improved the prediction of 30-day (p = 0.04) mortality. The integrated discrimination index was 0.03 (95% CI, 0.01-0.06, p = 0.01), meaning that the difference in predicted risk between patients who died and those who survived increased by 3% due to the addition of frailty determined by the EFS to the EuroSCORE II. Frailty also was associated significantly with a decreased cumulative probability of discharge from the ICU (p = 0.02) and an increased incidence of discharge to a health care facility (p = 0.01). CONCLUSION: The EFS has a good predictive ability for 30-day mortality after cardiac surgery in elderly patients and improves the prediction of 30-day mortality over the use of the EuroSCORE II.