Añón José M, Arellano María Soledad, Pérez-Márquez Manuel, Díaz-Alvariño Claudia, Márquez-Alonso José A, Rodríguez-Peláez Jorge, Nanwani-Nanwani Kapil, Martín-Pellicer Ana, Civantos Belén, López-Fernández Alba, Seises Irene, García-Nerín Jorge, Figueira Juan C, Casero Henar, Vejo Javier, Agrifoglio Alexander, Cachafeiro Lucía, Díaz-Almirón Mariana, Villar Jesús
Intensive Care Unit, Hospital Universitario La Paz, Paseo de la Castellana 261, 28046, Madrid, Spain.
Instituto de Investigación del Hospital Universitario La Paz (IdiPAZ), Madrid, Spain.
Trials. 2021 Jun 29;22(1):423. doi: 10.1186/s13063-021-05370-x.
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.
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.
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.
ClinicalTrials.gov NCT04265625. Registered on February 11, 2020.
气管切开术是重症监护病房（ICU）中最常用的技术之一。纤维支气管镜检查（FB）是进行经皮扩张气管切开术（PDT）时的一项安全措施，但围绕将FB作为该手术常规组成部分的争议仍然存在。一些欧洲国家的全国性调查显示，FB的使用并不规范。回顾性研究并未显示在使用或不使用支气管镜进行的手术之间并发症有显著差异。由于缺乏证据，国际指南未能就FB在PDT中的使用制定建议。
这是一项多中心（在发表本文时为三个中心）随机对照临床试验，旨在研究使用FB进行经皮气管切开术的安全性。我们将纳入所有入住ICU且因长时间机械通气而需要进行经皮气管切开术且无FB使用排除标准的连续成年患者。符合条件的患者将被随机分配接受盲法PDT或内镜引导下的PDT。所有手术均由经验丰富的PDT和FB重症监护医生进行。数据安全与监测委员会（DSMB）将对试验进行监测。主要结局是围手术期并发症的发生率。
FB在进行PDT时是一项安全技术，尽管其使用在所有ICU中并非普遍作为常规做法被接受。PDT是否应常规在内镜引导下进行监测？本研究将评估FB监测在PDT中的作用。
ClinicalTrials.gov NCT04265625。于2020年2月11日注册。
