跳至主要内容
临床试验/NCT07288255
NCT07288255已完成不适用

Application of 'One-stop' Single-lumen Endotracheal Intubation for Electromagnetic Navigation Bronchoscopy-guided Localization and Resection of Pulmonary Nodules: a Single-center Retrospective Cohort Analysis

Ruijin Hospital1 个研究点 分布在 1 个国家目标入组 375 人开始时间: 2023年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
375
试验地点
1
主要终点
Incidence of postoperative complications

研究概览

简要总结

The goal of this clinical study is to evaluate the practicality, safety, and feasibility of a 'one-stop' single-lumen (SL) endotracheal intubation strategy for patients undergoing wedge resection of early-stage lung nodules with electromagnetic navigation bronchoscopy (ENB)-guided localization. The main question it aims to answer is:

• Is the 'one-stop' SL strategy, where an SL tube is used continuously from ENB localization through surgery, non-inferior to the conventional practice of switching from an SL to a double-lumen (DL) tube in terms of perioperative outcomes and complication rates?

Participants scheduled for ENB-guided localization followed by wedge resection will be managed with either the proposed 'one-stop' SL intubation method or the conventional SL-to-DL conversion method. Researchers will compare key perioperative indicators and patient outcomes between the two groups.

详细描述

With increased health awareness and the widespread use of low-dose CT for lung cancer screening, early detection rates have risen. For early-stage non-small cell lung cancer, sub-lobar resection (segmentectomy or wedge resection) is now strongly recommended for peripheral nodules ≤2 cm without nodal involvement, as per recent landmark trials and NCCN guidelines. However, for wedge resection, precise localization and minimization of pulmonary function impairment still pose challenges for thoracic surgeons. Therefore, achieving effective resection while preserving lung function as much as possible necessitates precise localization of pulmonary nodules.

The CT-guided hook-wire localization method is currently the most frequently used technique in clinical practice for pulmonary nodule localization, but patients may experience significant pain and there is a risk of dislodgement of the hook wire during patient transfer or positioning before surgery. Furthermore, CT localization results in a high risk of pneumothorax and bleeding. The emergence of electromagnetic navigation bronchoscopy (ENB) not only alleviates patient discomfort but also reduces surgical time and lowers the risk of complications.

Typically, during ENB-guided localization, a single-lumen (SL) endotracheal tube is used under general anesthesia and subsequently replaced with a double-lumen (DL) endotracheal tube after the procedure. However, the conversion from SL to DL could potentially elevate the possibility of airway damage and anesthetic complications. Therefore, in patients undergoing wedge resection with ENB-guided localization, the investigators propose a 'one-stop' SL strategy, in which an SL tube is employed throughout the entire process from localization to surgery.

This study aimed to evaluate the practicality of utilizing SL endotracheal intubation for the entire process of ENB-guided localization and subsequent surgical procedure, referred as 'one-stop' SL. By comparing the conventional practice of the transition from SL to DL intubation with our proposed 'one-stop' SL intubation method based on perioperative indicators and patient outcomes, the investigators hope to determine whether the 'one-stop' SL strategy is safe and feasible clinically.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients who had pulmonary nodules and underwent video-assisted thoracoscopic surgery (VATS) lung surgery with ENB-guided nodule localization

排除标准

  • Patients who received non-intubated anesthesia or underwent wedge resection combined with lobectomy or segmentectomy were excluded.
  • Perioperative data were missing.

结局指标

主要结局

Incidence of postoperative complications

时间窗: Within 30 days postoperatively

Postoperative complications included the incidence of complications such as pneumonia, atelectasis, pneumothorax, air leakage, and pleural effusion.

Incidence of postoperative complications

时间窗: Within 30 days postoperatively

Postoperative complications included the incidence of complications such as pneumonia, atelectasis, pneumothorax, air leakage, and pleural effusion.

次要结局

  • Pain score(Perioperative)
  • Semiquantitative cough strength score(Perioperative)
  • Pain score(Perioperative)
  • Semiquantitative cough strength score(Perioperative)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hecheng Li M.D., Ph.D

Ruijin Hospital, Department of Thoracic Surgery

Ruijin Hospital

研究点 (1)

Loading locations...

相似试验