CCM:经皮扩张气管切开术中的纤维支气管镜监测：一项多中心随机对照试验——FIBERTRACH随机临床试验

Abstract

Objectives: To assess the prevalence of perioperative complications of endoscopic-guided percutaneous dilatational tracheostomy vs. nonendoscopic-guided percutaneous dilatational tracheostomy.

目的：​ 评估内镜引导下经皮扩张气管切开术与非内镜引导下经皮扩张气管切开术的围手术期并发症发生率。

Design: Multicenter, unblinded, randomized parallel-group trial with an intention-to-treat analysis conducted from December 2019 to December 2024. ClinicalTrials.gov Identifier: NCT04265625.

设计：​ 多中心、非盲法、随机平行组试验，采用意向性分析（ITT），研究时间为2019年12月至2024年12月。ClinicalTrials.gov注册号：NCT04265625。

Setting: Four medical-surgical ICUs in Spain.

地点：​ 西班牙的四家内外科重症监护病房（ICU）。

Patients: Adults undergoing tracheostomy for prolonged mechanical ventilation were enrolled.

患者：​ 纳入因长期机械通气而接受气管切开术的成年患者。

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.

干预措施：​ 患者被随机分配至：1）内镜引导下经皮扩张气管切开术组；或 2）非内镜引导下经皮扩张气管切开术组。两组均采用单步扩张法，且均由经验丰富的临床医生对无风险因素的患者进行操作。

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 H2O; 95% CI, 7.5-13.2; p < 0.001) during the procedure and higher mean Paco2 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.

测量指标与主要结果：​ 主要终点是围手术期并发症的发生率。次要终点包括术中气道压力、术后气体交换情况以及出院时的全因死亡率。我们共纳入442例患者，每组各221例。内镜引导组有25例（11.3%）发生围手术期并发症，非内镜引导组有29例（13.1%）（95% CI, -6.8 至 10.4；p = 0.663）。与非内镜引导组相比，随机分配至内镜引导组的患者在术中表现出更高的平均吸气峰压（47.4 ± 17.6 vs. 37.05 ± 10.6 cm H2O；95% CI, 7.5-13.2；p < 0.001），且在术毕时平均动脉血二氧化碳分压（PaCO2）更高（44.3 ± 8.9 vs. 41.5 ± 8.1 mm Hg；95% CI, 1.1-4.4；p = 0.001）。

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.

结论：​ 在接受经皮扩张气管切开术的危重患者中，就并发症发生率而言，常规使用内镜引导并未显示出优于无内镜引导的操作。