Background: Tracheostomy is one of the most frequent techniques in intensive care units (ICU). Fiberoptic bronchoscopy (FB) is a safety measure when performing a percutaneous dilatational tracheostomy (PDT), but the controversy surrounding the routine use of FB as part of the procedure remains open. National surveys in some European countries showed that the use of FB is non-standardized. Retrospective studies have not shown a significant difference in complications between procedures performed with or without a bronchoscope. International guidelines have not been able to establish recommendations regarding the use of FB in PDT due to lack of evidence.Design: This is a multicenter (three centers at the time of publishing this paper) randomized controlled clinical trial to examine the safety of percutaneous tracheostomy using FB. We will include all consecutive adult patients admitted to the ICU in whom percutaneous tracheostomy for prolonged mechanical ventilation is indicated and with no exclusion criteria for using FB. Eligible patients will be randomly assigned to receive blind PDT or PDT under endoscopic guidance. All procedures will be performed by experienced intensivists in PDT and FB. A Data Safety and Monitoring Board (DSMB) will monitor the trial. The primary outcome is the incidence of perioperative complications.Discussion: FB is a safe technique when performing PDT although its use is not universally accepted in all ICUs as a routine practice. Should PDT be monitored routinely with endoscopic guidance? This study will assess the role of FB monitoring during PDT.Trial registration: ClinicalTrials.gov NCT04265625. Registered on February 11, 2020

Background/Objectives: Stenotrophomonas maltophilia is a common cause of lower respiratory tract infection (LRTI) in critically ill patients, but differences between ventilator-associated tracheobronchitis (VAT) and ventilator- or hospital-acquired pneumonia (VAP/HAP) remain unclear. We aimed to compare clinical outcomes between VAT and VAP/HAP and, secondarily, to explore antimicrobial treatment patterns and their association with treatment failure. Methods: We conducted a retrospective two-center cohort study of adults admitted to intensive care units (ICUs) in Madrid, Spain, between August 2021 and December 2025 with clinically significant S. maltophilia VAT, VAP, or HAP. The primary analysis included only the first (index) episode per patient. Results: Sixty-seven patients contributed 90 episodes. Among index episodes, therapeutic failure was more frequent in VAP/HAP than in VAT (40.6% vs. 14.3%; absolute risk difference, 26.3 percentage points; 95% confidence interval [CI], 5.0–45.2; p = 0.026). In a parsimonious Firth’s penalized logistic regression, VAP/HAP remained associated with therapeutic failure (adjusted odds ratio, 4.06; 95% CI, 1.32–14.25; p = 0.014). Results were consistent after adjustment for SOFA score at infection onset and when the analysis was restricted to VAP. ICU mortality was numerically higher in VAP/HAP (46.9% vs. 25.7%). In an exploratory Firth’s model, laboratory-reported in vitro active antimicrobial therapy was associated with lower odds of failure (adjusted odds ratio, 0.19; 95% CI, 0.05–0.72; p = 0.014); however, this exposure was susceptible to time-dependent bias, and empirical anti-S. maltophilia therapy, defined at treatment initiation, was not associated with failure (26.7% vs. 26.9%). Conclusions: The clinical and prognostic significance of respiratory S. maltophilia infection appears to differ by syndrome. VAP/HAP was associated with more therapeutic failure than VAT. The association between in vitro active therapy and lower failure was exploratory and requires confirmation, and no comparative effectiveness conclusions can be drawn for individual antimicrobial agents.