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临床试验/NCT07569107
NCT07569107尚未招募不适用

Learning Curve Analysis of Double-Lumen Tube Placement in Anesthesiology Residents: The Impact of Prior Experience and Laryngoscope Type

Ankara Ataturk Sanatorium Training and Research Hospital1 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2026年5月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
33
试验地点
1
主要终点
• Total number of DLT malpositions confirmed by fiberoptic bronchoscopy

研究概览

简要总结

Placement of a double-lumen tube (DLT) is one of the fundamental techniques for safely achieving one-lung ventilation in thoracic anesthesia. Compared with standard single-lumen endotracheal tubes, DLTs have a larger diameter, greater length, and a more rigid structure. These characteristics make intubation with a DLT considerably more challenging in both normal and difficult airways, potentially increasing the risk of upper airway trauma and postoperative complications, thereby contributing to increased overall morbidity and mortality.

Despite its widespread clinical use, DLT placement remains a technically demanding procedure due to anatomical variability, limited visualization, and operator-dependent performance differences. The reported incidence of DLT malposition in the literature ranges from 32% to 83%. Even in studies reporting lower rates (approximately 32.44%), it is acknowledged that a substantial number of malpositions may go undetected, which can critically impact both patient safety and surgical outcomes. In addition to initial misplacement, repeated repositioning of a malpositioned DLT may itself lead to airway injury. Increased manipulation of the DLT within the bronchial tree may result in excessive trauma.

DLT malposition may predispose patients to inadequate lung isolation, hypoxemia, tracheobronchial injury, and potential complications such as barotrauma or pneumothorax. Operator experience is recognized as a key determinant of success in airway management. Previous studies have demonstrated that technical proficiency in advanced airway interventions improves with cumulative clinical experience. However, most existing research has focused on basic airway devices, and evidence regarding advanced airway techniques such as DLT placement remains limited. Furthermore, the relative contributions of operator experience, airway difficulty, and device technology to procedural success have not been fully elucidated.

To address the need for easier and safer endotracheal intubation, various types of video laryngoscopes have been developed as alternatives to direct laryngoscopy. Nevertheless, it remains unclear whether video-assisted airway management reduces DLT malposition rates across different levels of operator experience.

Simulation-based training has become increasingly important in modern anesthesiology education, providing a safe and standardized environment for the assessment of airway management skills. Accordingly, there is a need for simulation-based studies evaluating learning curves and technical performance in DLT placement.

The primary aim of this study is to evaluate the effects of overall clinical experience and prior DLT placement experience on malposition rates during DLT insertion procedures performed in a simulation setting among anesthesiology residents. Secondary objectives include comparing the performance of video laryngoscopy and Macintosh laryngoscopy, as well as analyzing learning curves across repeated attempts. Additionally, the interaction between experience level, type of laryngoscope used, and airway difficulty will be investigated.

Study Design and Population This study will be conducted in accordance with the Declaration of Helsinki and will be carried out at Ankara Atatürk Sanatorium Training and Research Hospital after obtaining approval from the institutional ethics committee.

The study is designed as a prospective, observer-blinded, simulation-based study with repeated measures. It aims to evaluate DLT placement performance using standardized airway simulation models.

All anesthesiology residents working in the Department of Anesthesiology and Reanimation at Ankara Atatürk Sanatorium Training and Research Hospital will be invited to participate on a voluntary basis (total of 33 participants). Written informed consent will be obtained from all participants.

Anesthesiology residents with varying levels of experience will be included voluntarily. Participants will be stratified based on years of residency training and the number of prior DLT placements performed.

Airway simulation will be conducted using high-fidelity airway manikins equipped with bronchial anatomy modules. Intubation will be performed using a 37 Fr DLT. Simulation platforms with fiberoptic verification capability will be utilized. Prior to data collection, participants will receive standardized training on DLT placement.

详细描述

Training Provided to All Participants:

  • One standardized theoretical training session
  • One video demonstration
  • One practice attempt for each scenario (not included in the data analysis)

The following variables will be recorded:

  • Age of the participant
  • Sex
  • Year of residency training
  • Number of prior real-life DLT intubations performed
  • Intubation time
  • Number of attempts
  • Presence of malposition
  • Visual Analog Scale (VAS) difficulty score (participants will rate the difficulty of each attempt on a scale from 0 = very easy to 100 = very difficult)

Each participant will perform the following four clinical scenarios in a randomized order:

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Being an anesthesiology resident at the study institution
  • Voluntary participation

排除标准

  • Refusal to participate in the study
  • Prior participation in the same simulation scenario

研究组 & 干预措施

Anesthesiology residents with varying levels of experience

Anesthesiology residents with varying levels of experience will be included voluntarily. Participants will be stratified based on years of residency training and the number of prior DLT placements performed.

干预措施: Double lumen tube entubation (Other)

结局指标

主要结局

• Total number of DLT malpositions confirmed by fiberoptic bronchoscopy

时间窗: DLT intubation will be completed within 48 hours. The total number of malpositions within 48 hours will be recorded.

Malposition is defined as any of the following: * Failure of the bronchial cuff to be positioned in the left main bronchus, remaining instead in the trachea * Unintentional placement of the DLT into the right bronchial system * Advancement of the DLT at least 1 cm beyond the optimal position within the left main bronchus

DLT malpositions

时间窗: 1 hour

Malposition is defined as any of the following: * Failure of the bronchial cuff to be positioned in the left main bronchus, remaining instead in the trachea * Unintentional placement of the DLT into the right bronchial system * Advancement of the DLT at least 1 cm beyond the optimal position within the left main bronchus

次要结局

未报告次要终点

研究者

发起方
Ankara Ataturk Sanatorium Training and Research Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Ramazan Baldemir

Clinic Associate Professor

Ankara Ataturk Sanatorium Training and Research Hospital

研究点 (1)

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