Department of Anesthesiology & Huzhou Key Laboratory of Basic Research and Clinical Translation for Neuromodulation, Huzhou Central Hospital || The Affiliated Huzhou Hospital, Zhejiang University School of Medicine || Affiliated Central Hospital Huzhou University, No. 1558 Sanhuan North Road, Wuxing District, Huzhou, Zhejiang Province, 313000, China.
Department of Anesthesiology, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China.
Trials. 2023 Jan 29;24(1):67. doi: 10.1186/s13063-023-07075-9.
The double-lumen tube (DLT) is an essential equipment for thoracic anesthesia and the precise position of DLT placement is particularly important for anesthesia and surgery. However, the incidence of DLT malposition remains high and it leads to lung isolation failure and hypoxemia during one-lung ventilation. This trial aims to explore the clinical application and efficacy of intubation in the lateral position under general anesthesia induction to reduce the incidence of DLT malposition in patients undergoing unilateral video-assisted thoracic surgery (VATS).
In this prospective, single-center, parallel group, randomized, controlled trial, we will recruit 108 patients, aged 18-80 years, scheduled for elective unilateral VATS with DLT intubation under general anesthesia, and they will be randomly assigned to two groups: a lateral DLT intubation group (group L) and a conventional supine DLT intubation group (group C). The left-sided DLT will be used to intubate in patients of both groups. The position of DLT will be confirmed and adjusted by using the fiberoptic bronchoscopy (FOB). The primary outcome is the incidence of DLT malposition observed via the FOB, and the secondary outcomes include the time of intubation, the frequency and duration of re-adjustments of DLT placement under FOB, whether to re-intubate, intraoperative vital signs, and postoperative recovery.
Accurate DLT positioning is crucially important for thoracic surgery, but the incidence of DLT malposition is still high in the present clinical practice of thoracic anesthesia. This trial aims to investigate whether lateral DLT intubation can reduce the incidence of DLT malposition, with more stable intraoperative vital signs and less postoperative complications.
The study protocol was registered at Chinese Clinical Trial Registry ( http://www.chictr.org.cn ) with registration number: ChiCTR2200060794 on June 11, 2022.
双腔管（DLT）是胸科麻醉的重要设备，DLT 的精确位置对于麻醉和手术尤为重要。然而，DLT 位置不当的发生率仍然很高，这会导致单肺通气期间肺隔离失败和低氧血症。本试验旨在探讨全麻诱导下侧卧位插管在减少单侧电视辅助胸腔手术（VATS）患者 DLT 位置不当发生率方面的临床应用和疗效。
这是一项前瞻性、单中心、平行组、随机、对照试验，我们将招募 108 名年龄在 18-80 岁之间、全身麻醉下拟行单侧 VATS 并使用 DLT 插管的择期患者，将其随机分为两组：侧卧位 DLT 插管组（组 L）和常规仰卧位 DLT 插管组（组 C）。两组患者均使用左侧 DLT 插管。使用纤维支气管镜（FOB）确认和调整 DLT 位置。主要结局是通过 FOB 观察到的 DLT 位置不当发生率，次要结局包括插管时间、FOB 下调整 DLT 位置的频率和持续时间、是否需要重新插管、术中生命体征和术后恢复情况。
准确的 DLT 定位对胸科手术至关重要，但在目前的胸科麻醉临床实践中，DLT 位置不当的发生率仍然很高。本试验旨在探讨侧卧位 DLT 插管是否能降低 DLT 位置不当的发生率，同时术中生命体征更稳定，术后并发症更少。
研究方案于 2022 年 6 月 11 日在中国临床试验注册中心（http://www.chictr.org.cn）注册，注册号：ChiCTR2200060794。
