José Manuel Añón, Juan Carlos Figueira, Belén Civantos, Alexander Agrifoglio, Margarita Márquez, Patricia Rodríguez, Manuel Pérez-Márquez, Covadonga Rodríguez, Renata García-Gigorro, María Paz Escuela, Andoni García-Muñoz, Jorge Rodríguez-Peláez, Mónica Hernández, María Soledad Arellano, Mario Dalorzo, María Muñoz, Belén Quesada, Guillermo Jiménez, Ignacio Fernández, Claudia Díaz-Alvariño, Alba López-Fernández, Jesús Manzanares, Lucía Cachafeiro, Eva Perales, Pablo Millán, Manuel Sánchez, María José Asensio, Javier Vejo, Mariana Díaz-Almirón, Jesús Villar
{"title":"纤维支气管镜监测经皮扩张性气管切开术：一项多中心、随机、对照试验。FIBERTRACH随机临床试验。","authors":"José Manuel Añón, Juan Carlos Figueira, Belén Civantos, Alexander Agrifoglio, Margarita Márquez, Patricia Rodríguez, Manuel Pérez-Márquez, Covadonga Rodríguez, Renata García-Gigorro, María Paz Escuela, Andoni García-Muñoz, Jorge Rodríguez-Peláez, Mónica Hernández, María Soledad Arellano, Mario Dalorzo, María Muñoz, Belén Quesada, Guillermo Jiménez, Ignacio Fernández, Claudia Díaz-Alvariño, Alba López-Fernández, Jesús Manzanares, Lucía Cachafeiro, Eva Perales, Pablo Millán, Manuel Sánchez, María José Asensio, Javier Vejo, Mariana Díaz-Almirón, Jesús Villar","doi":"10.1097/CCM.0000000000007078","DOIUrl":null,"url":null,"abstract":"<p><strong>Objectives: </strong>To assess the prevalence of perioperative complications of endoscopic-guided percutaneous dilatational tracheostomy vs. nonendoscopic-guided percutaneous dilatational tracheostomy.</p><p><strong>Design: </strong>Multicenter, unblinded, randomized parallel-group trial with an intention-to-treat analysis conducted from December 2019 to December 2024. ClinicalTrials.gov Identifier: NCT04265625.</p><p><strong>Setting: </strong>Four medical-surgical ICUs in Spain.</p><p><strong>Patients: </strong>Adults undergoing tracheostomy for prolonged mechanical ventilation were enrolled.</p><p><strong>Interventions: </strong>Patients were randomized to: 1) endoscopic-guided percutaneous dilatational tracheostomy or 2) nonendoscopic-guided percutaneous dilatational tracheostomy, both performed with the single dilatation method and by experienced clinicians in patients with no risk factors.</p><p><strong>Measurements and main results: </strong>The primary endpoint was the prevalence of perioperative complications. The secondary endpoints included airway pressures during the procedure, gas exchange after the procedure and all-cause mortality at hospital discharge. We enrolled 442 patients, 221 patients assigned to each arm. Twenty-five patients (11.3%) in the endoscopic-guided percutaneous dilatational tracheostomy group and 29 (13.1%) in nonendoscopic-guided percutaneous dilatational tracheostomy group had perioperative complications (95% CI, -6.8 to 10.4; p = 0.663). Patients randomized to endoscopic-guided percutaneous dilatational tracheostomy had higher mean peak inspiratory pressure (47.4 ± 17.6 vs. 37.05 ± 10.6 cm H 2 O; 95% CI, 7.5-13.2; p < 0.001) during the procedure and higher mean Pa co2 at the end of the procedure (44.3 ± 8.9 vs. 41.5 ± 8.1 mm Hg; 95% CI, 1.1-4.4; p = 0.001) than nonendoscopic-guided percutaneous dilatational tracheostomy patients.</p><p><strong>Conclusions: </strong>In critically ill patients undergoing percutaneous dilatational tracheostomy, the routine use of endoscopic guidance did not demonstrate superiority over procedures performed without endoscopic guidance in terms of complication rates.</p>","PeriodicalId":10765,"journal":{"name":"Critical Care Medicine","volume":" ","pages":"1124-1135"},"PeriodicalIF":6.0000,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Fiberoptic Bronchoscopy Monitoring During Percutaneous Dilatational Tracheostomy: A Multicenter, Randomized, Controlled Trial. 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ClinicalTrials.gov Identifier: NCT04265625.</p><p><strong>Setting: </strong>Four medical-surgical ICUs in Spain.</p><p><strong>Patients: </strong>Adults undergoing tracheostomy for prolonged mechanical ventilation were enrolled.</p><p><strong>Interventions: </strong>Patients were randomized to: 1) endoscopic-guided percutaneous dilatational tracheostomy or 2) nonendoscopic-guided percutaneous dilatational tracheostomy, both performed with the single dilatation method and by experienced clinicians in patients with no risk factors.</p><p><strong>Measurements and main results: </strong>The primary endpoint was the prevalence of perioperative complications. The secondary endpoints included airway pressures during the procedure, gas exchange after the procedure and all-cause mortality at hospital discharge. We enrolled 442 patients, 221 patients assigned to each arm. Twenty-five patients (11.3%) in the endoscopic-guided percutaneous dilatational tracheostomy group and 29 (13.1%) in nonendoscopic-guided percutaneous dilatational tracheostomy group had perioperative complications (95% CI, -6.8 to 10.4; p = 0.663). Patients randomized to endoscopic-guided percutaneous dilatational tracheostomy had higher mean peak inspiratory pressure (47.4 ± 17.6 vs. 37.05 ± 10.6 cm H 2 O; 95% CI, 7.5-13.2; p < 0.001) during the procedure and higher mean Pa co2 at the end of the procedure (44.3 ± 8.9 vs. 41.5 ± 8.1 mm Hg; 95% CI, 1.1-4.4; p = 0.001) than nonendoscopic-guided percutaneous dilatational tracheostomy patients.</p><p><strong>Conclusions: </strong>In critically ill patients undergoing percutaneous dilatational tracheostomy, the routine use of endoscopic guidance did not demonstrate superiority over procedures performed without endoscopic guidance in terms of complication rates.</p>\",\"PeriodicalId\":10765,\"journal\":{\"name\":\"Critical Care Medicine\",\"volume\":\" \",\"pages\":\"1124-1135\"},\"PeriodicalIF\":6.0000,\"publicationDate\":\"2026-05-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Critical Care Medicine\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1097/CCM.0000000000007078\",\"RegionNum\":1,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2026/2/26 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"Q1\",\"JCRName\":\"CRITICAL CARE MEDICINE\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Critical Care Medicine","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1097/CCM.0000000000007078","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2026/2/26 0:00:00","PubModel":"Epub","JCR":"Q1","JCRName":"CRITICAL CARE MEDICINE","Score":null,"Total":0}
引用次数: 0
摘要
目的：比较内镜引导下经皮气管扩张造瘘术与非内镜引导下经皮气管扩张造瘘术围手术期并发症的发生率。设计：2019年12月至2024年12月进行多中心、非盲、随机平行组试验，并进行意向治疗分析。ClinicalTrials.gov标识符：NCT04265625。环境：西班牙的四个内科外科icu。患者：接受气管切开术进行长时间机械通气的成人。干预措施：患者随机分为：1)内镜引导下经皮扩张性气管造口术和2)非内镜引导下经皮扩张性气管造口术，均采用单一扩张方法，由经验丰富的临床医生在无危险因素的患者中进行。测量和主要结果：主要终点是围手术期并发症的发生率。次要终点包括手术过程中的气道压力、手术后的气体交换和出院时的全因死亡率。我们招募了442名患者，每组221名患者。内镜引导下经皮气管扩张造瘘组25例（11.3%）出现围手术期并发症，非内镜引导下经皮气管扩张造瘘组29例（13.1%）出现围手术期并发症（95% CI, -6.8 ~ 10.4; p = 0.663）。随机分配到内镜引导下经皮扩张性气管造口术的患者在手术过程中平均峰值吸气压（47.4±17.6 vs. 37.05±10.6 cm H2O; 95% CI, 7.5-13.2; p < 0.001）高于非内镜引导下经皮扩张性气管造口术的患者，手术结束时平均Paco2（44.3±8.9 vs. 41.5±8.1 mm Hg; 95% CI, 1.1-4.4; p = 0.001）。结论：在接受经皮扩张性气管切开术的危重患者中，常规内镜引导并不比无内镜指导的手术在并发症发生率上有优势。
Fiberoptic Bronchoscopy Monitoring During Percutaneous Dilatational Tracheostomy: A Multicenter, Randomized, Controlled Trial. The FIBERTRACH Randomized Clinical Trial.
Objectives: To assess the prevalence of perioperative complications of endoscopic-guided percutaneous dilatational tracheostomy vs. nonendoscopic-guided percutaneous dilatational tracheostomy.
Design: Multicenter, unblinded, randomized parallel-group trial with an intention-to-treat analysis conducted from December 2019 to December 2024. ClinicalTrials.gov Identifier: NCT04265625.
Setting: Four medical-surgical ICUs in Spain.
Patients: Adults undergoing tracheostomy for prolonged mechanical ventilation were enrolled.
Interventions: Patients were randomized to: 1) endoscopic-guided percutaneous dilatational tracheostomy or 2) nonendoscopic-guided percutaneous dilatational tracheostomy, both performed with the single dilatation method and by experienced clinicians in patients with no risk factors.
Measurements and main results: The primary endpoint was the prevalence of perioperative complications. The secondary endpoints included airway pressures during the procedure, gas exchange after the procedure and all-cause mortality at hospital discharge. We enrolled 442 patients, 221 patients assigned to each arm. Twenty-five patients (11.3%) in the endoscopic-guided percutaneous dilatational tracheostomy group and 29 (13.1%) in nonendoscopic-guided percutaneous dilatational tracheostomy group had perioperative complications (95% CI, -6.8 to 10.4; p = 0.663). Patients randomized to endoscopic-guided percutaneous dilatational tracheostomy had higher mean peak inspiratory pressure (47.4 ± 17.6 vs. 37.05 ± 10.6 cm H 2 O; 95% CI, 7.5-13.2; p < 0.001) during the procedure and higher mean Pa co2 at the end of the procedure (44.3 ± 8.9 vs. 41.5 ± 8.1 mm Hg; 95% CI, 1.1-4.4; p = 0.001) than nonendoscopic-guided percutaneous dilatational tracheostomy patients.
Conclusions: In critically ill patients undergoing percutaneous dilatational tracheostomy, the routine use of endoscopic guidance did not demonstrate superiority over procedures performed without endoscopic guidance in terms of complication rates.
期刊介绍：
Critical Care Medicine is the premier peer-reviewed, scientific publication in critical care medicine. Directed to those specialists who treat patients in the ICU and CCU, including chest physicians, surgeons, pediatricians, pharmacists/pharmacologists, anesthesiologists, critical care nurses, and other healthcare professionals, Critical Care Medicine covers all aspects of acute and emergency care for the critically ill or injured patient.
Each issue presents critical care practitioners with clinical breakthroughs that lead to better patient care, the latest news on promising research, and advances in equipment and techniques.
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