The role of routine FIBERoptic bronchoscopy monitoring during percutaneous dilatational TRACHeostomy (FIBERTRACH): a study protocol for a randomized, controlled clinical trial

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