Abstract
BackgroundTracheostomy 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.DesignThis 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.DiscussionFB 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 registrationClinicalTrials.gov NCT04265625. Registered on February 11, 2020
Highlights
Tracheostomy is one of the most frequent techniques in intensive care units (ICU)
Should percutaneous dilatational tracheostomy (PDT) be monitored routinely with endoscopic guidance? This study will assess the role of Fiberoptic bronchoscopy (FB) monitoring during PDT
Other responsibilities of the study coordinator and the trial management team, where a statistician is included, are (i) planning and conducting the study: designing the protocol, designing the randomization process, and managing and controlling the data quality; (ii) monitoring recruitment rates, taking actions to increase patient enrolment, and taking actions to increase the number of participating centers; and monitoring follow-up and auditing (iii) statistical analysis, research reporting, and helping in writing the final manuscript. This is a protocol for a randomized controlled trial designed to evaluate the efficacy of percutaneous tracheostomy under endoscopic guidance versus blind percutaneous tracheostomy and to evaluate the effects on ventilatory parameters during percutaneous tracheostomy with and without endoscopic control
Summary
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. Tracheostomy is one of the most frequently performed techniques in intensive care units (ICUs). In 1985, Ciaglia et al [2] described the percutaneous dilatational tracheostomy (PDT) that met the requirements of simplicity, swiftness, and safety, which, along with the possibility of being performed at the bedside, developed a new way of understanding surgical airway access in the critically ill patient. The “routine” use of endoscopic guidance as part of percutaneous tracheostomy is controversial [10,11,12,13] and guidelines cannot establish recommendation levels [14,15,16]
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