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

2026年5月11日 更新者:Ramazan Baldemir、Ankara Ataturk Sanatorium Training and Research Hospital

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.

研究概览

详细说明

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:

  1. Scenario: Normal airway - Macintosh laryngoscope
  2. Scenario: Normal airway - Video laryngoscope
  3. Scenario: Difficult airway - Macintosh laryngoscope
  4. Scenario: Difficult airway - Video laryngoscope Participants will complete the scenarios in different sequences, determined by computer-based randomization.

For each participant:

  • Each scenario will be performed three times (three repetitions).
  • Adequate rest periods will be provided between repetitions to minimize fatigue (at least 10 minutes between repetitions).
  • A maximum of two intubation attempts will be allowed per repetition.
  • Participants will perform no more than two scenarios per day.
  • DLT placement will be confirmed using fiberoptic bronchoscopy by two independent anesthesiologists who are blinded to the identity and experience level of the operator. Interobserver agreement will be assessed using Cohen's kappa analysis.

If successful intubation is not achieved after two attempts, the procedure will be recorded as a failure for that repetition. The presence of malposition will be recorded after each attempt. The total number of malpositions observed across all procedures and repetitions will be documented.

Definition of Malposition:

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 Statistical Analysis Statistical analyses will be performed using SPSS Version 27 (IBM Corp., Armonk, NY, USA), R software (R Foundation for Statistical Computing, Vienna, Austria), and Microsoft Excel (Microsoft Corp., USA). Descriptive statistics will be presented as mean ± standard deviation or median (interquartile range), as appropriate. Categorical variables will be expressed as counts and percentages. The normality of data distribution will be assessed using the Shapiro-Wilk test.

Given the repeated-measures structure of the data, mixed-effects models will be employed for analysis. Learning curve analyses will be conducted using the Cumulative Sum Control Chart (CUSUM) method and regression-based slope analyses. A p-value of < 0.05 will be considered statistically significant.

Sample Size In this study, the sample size was determined using an event-based approach, taking into account the lack of directly comparable studies in the literature and the limitations of conventional sample size calculation methods for multilevel data with repeated measures. A total of 33 participants, 4 scenarios, and 3 repetitions are planned, yielding 396 measurements.

Based on the lowest reported malposition rate in the literature (32%), approximately 126 events (malpositions) are expected. According to the commonly recommended rule of at least 10 events per variable in multivariable regression analyses, a minimum of 50 events would be required for approximately 5 variables to be included in the model. Therefore, the anticipated number of events is considered more than sufficient, and the planned sample size is deemed adequate to test the study hypotheses.

研究类型

观察性的

注册 (估计的)

33

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

  • 姓名:Ramazan BALDEMİR, clinic Associate Professor
  • 电话号码:+905303570166
  • 邮箱:baldemir2323@gmail.com

学习地点

      • Ankara、土耳其(türkiye)
        • Ankara Ataturk Sanatorium Training and Research Hospital, Ankara, 06280

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 孩子
  • 成人
  • 年长者

接受健康志愿者

不

取样方法

非概率样本

研究人群

• Being an anesthesiology resident at the Ankara Atatürk Sanatorium Training and Research Hospital

描述

Inclusion Criteria:

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

Exclusion Criteria:

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

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
干预/治疗
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.

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.

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

  1. Scenario: Normal airway - Macintosh laryngoscope
  2. Scenario: Normal airway - Video laryngoscope
  3. Scenario: Difficult airway - Macintosh laryngoscope
  4. Scenario: Difficult airway - Video laryngoscope Participants will complete the scenarios in different sequences, determined by computer-based randomization.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
• DLT malposition rates confirmed by fiberoptic bronchoscopy
大体时间:DLT intubation will be completed within 48 hours. The malposition rates 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 intubation will be completed within 48 hours. The malposition rates within 48 hours will be recorded.
DLT malposition rates confirmed by fiberoptic bronchoscopy
大体时间:48 hours

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
48 hours

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Ramazan BALDEMİR、Ankara Ataturk Sanatorium Training and Research Hospital

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年5月10日

初级完成 (估计的)

2026年8月10日

研究完成 (估计的)

2026年8月10日

研究注册日期

首次提交

2026年4月29日

首先提交符合 QC 标准的

2026年4月29日

首次发布 (实际的)

2026年5月6日

研究记录更新

最后更新发布 (实际的)

2026年5月13日

上次提交的符合 QC 标准的更新

2026年5月11日

最后验证

2026年5月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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