NCT07569107

Brief Summary

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for all trials

Timeline
3mo left

Started May 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 29, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 6, 2026

Completed
4 days until next milestone

Study Start

First participant enrolled

May 10, 2026

Expected
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 10, 2026

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 10, 2026

Last Updated

May 6, 2026

Status Verified

April 1, 2026

Enrollment Period

3 months

First QC Date

April 29, 2026

Last Update Submit

April 29, 2026

Conditions

Keywords

Learning curvessimulation -based trainingdouble lumen tubeexperiencelaryngoscopesanesthesiology residents

Outcome Measures

Primary Outcomes (2)

  • • Total number of DLT malpositions confirmed by fiberoptic bronchoscopy

    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 total number of malpositions within 48 hours will be recorded.

  • DLT malpositions

    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

    1 hour

Study Arms (1)

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.

Other: Double lumen tube entubation

Interventions

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.

Anesthesiology residents with varying levels of experience

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Ataturk Sanatorium Training and Research Hospital, Ankara, 06280

Ankara, Turkey (Türkiye)

Location

Study Officials

  • Ramazan BALDEMİR

    ANKARA ATATURK SANATORİUM TRAİNİNG AND RESEARCH HOSPITAL

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ramazan BALDEMİR, clinic Associate Professor

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinic Associate Professor

Study Record Dates

First Submitted

April 29, 2026

First Posted

May 6, 2026

Study Start (Estimated)

May 10, 2026

Primary Completion (Estimated)

August 10, 2026

Study Completion (Estimated)

August 10, 2026

Last Updated

May 6, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations