胸外科气管损伤中分步插管策略与一步插管策略的比较：基于联合可视肺隔离导管与可视双腔支气管导管的 multicenter 随机对照试验方案
Stepwise versus one-step intubation strategy for tracheal injury in thoracic surgery: a multicenter randomized controlled trial protocol based on a combined visual lung isolation tube versus a video double-lumen tube.
文献信息
| PMID | 42983661 |
|---|---|
| 原文 | 在 PubMed 查看原文 ↗ |
| 发表日期 | 2026 |
| 作者 | Xiang Li |
| 作者单位 | Department of Anesthesiology, The First Affiliated Hospital of Anhui Medical University, 218 Jixi Road, Shushan District, Hefei, Anhui, 230032, China. |
| 期刊 | BMC anesthesiology |
| SCI 分区 | Q2 |
| IF | 3.2 |
| 研究类型 | 临床研究 · 临床 |
| 所属专科 | 咽喉科 |
中文摘要
背景： 气管损伤仍是胸外科肺隔离过程中具有临床意义的并发症。尽管可视双腔支气管导管（VDLT）改善了插管和支气管定位时的可视化，但如果声门后旋转操作仍然必要，仅靠可视化可能不足以减少气道创伤。联合可视肺隔离导管（联合导管）被开发用于实现预定的分步置入策略，同时保持与双腔支气管导管相当的外径。本试验旨在比较基于联合导管的分步策略与基于VDLT的传统一步策略。
方法： 这项 multicenter、前瞻性、随机对照试验将纳入192例接受择期胸外科手术并需要左侧单肺通气的成人患者。参与者将按1:1随机分配至联合导管组或VDLT组。主要结局是中重度气管损伤的发生率，定义为声门下区域、气管干、隆突或支气管的中度或重度黏膜损伤。次要结局包括部位特异性气管损伤、声带损伤、术后咽痛、声音嘶哑、插管相关变量、肺隔离质量、低氧事件、气道压力变量和围术期不良事件。支气管镜录像将由两名独立评估者进行集中盲法审阅。主要分析将在全分析集中使用混合效应回归模型进行，以考虑中心效应。
讨论： 本试验将评估预定的分步插管策略能否减少肺隔离期间的气管损伤。通过比较外径相当的器械所代表的两种策略，本研究可能有助于区分置入路径与器械尺寸的影响，并为声门后旋转操作在气道损伤中的作用提供机制性见解。
试验注册： 本研究已于2026年5月21日在中国临床试验注册中心（ChiCTR；注册号：ChiCTR2600125149）注册。试验详情可在以下网址公开获取：https://www.chictr.org.cn/showproj.html?proj=321664 。
英文摘要
BACKGROUND: Tracheal injury remains a clinically relevant complication during lung isolation for thoracic surgery. Although video double-lumen tubes (VDLTs) improve visualization during intubation and bronchial positioning, visualization alone may not sufficiently reduce airway trauma if post-glottic rotational manipulation remains necessary. A combined visual lung isolation tube (combined tube) was developed to enable a predefined stepwise insertion strategy while maintaining an external diameter comparable to that of a double-lumen tube. This trial aims to compare a stepwise strategy based on the combined tube with a conventional one-step strategy based on a VDLT.
METHODS: This multicenter, prospective, randomized controlled trial will enroll 192 adult patients undergoing elective thoracic surgery requiring left-sided one-lung ventilation. Participants will be randomized 1:1 to either the combined-tube group or the VDLT group. The primary outcome is the incidence of moderate-to-severe tracheal injury, defined as moderate or severe mucosal injury at the subglottic region, tracheal shaft, carina, or bronchus. Secondary outcomes include site-specific tracheal injury, vocal cord injury, postoperative sore throat, hoarseness, intubation-related variables, lung isolation quality, hypoxemic events, airway pressure variables, and perioperative adverse events. Bronchoscopic recordings will undergo centralized blinded review by two independent assessors. The primary analysis will be conducted in the full analysis set using mixed-effects regression models to account for center effects.
DISCUSSION: This trial will evaluate whether a predefined stepwise intubation strategy can reduce tracheal injury during lung isolation. By comparing two strategies represented by devices with comparable external diameters, the study may help distinguish the effect of insertion pathway from that of device size and provide mechanistic insight into the role of post-glottic rotational manipulation in airway injury.
TRIAL REGISTRATION: This study was registered with the Chinese Clinical Trial Registry (ChiCTR; Registration number: ChiCTR2600125149) on 21 May 2026. Details of the trial are publicly accessible at: https://www.chictr.org.cn/showproj.html?proj=321664 .