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

Autor: José M. Añón, María Soledad Arellano, Manuel Pérez-Márquez, Claudia Díaz-Alvariño, José A. Márquez-Alonso, Jorge Rodríguez-Peláez, Kapil Nanwani-Nanwani, Ana Martín-Pellicer, Belén Civantos, Alba López-Fernández, Irene Seises, Jorge García-Nerín, Juan C. Figueira, Henar Casero, Javier Vejo, Alexander Agrifoglio, Lucía Cachafeiro, Mariana Díaz-Almirón, Jesús Villar
Jazyk: angličtina
Rok vydání: 2021
Předmět:
Zdroj: Trials, Vol 22, Iss 1, Pp 1-7 (2021)
Druh dokumentu: article
ISSN: 1745-6215
26678950
DOI: 10.1186/s13063-021-05370-x
Popis: Abstract 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
Databáze: Directory of Open Access Journals
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