Learning Curves and Outcomes of Simulation-based TrainingNCT07569107
Learning Curve Analysis of Double-Lumen Tube Placement in Anesthesiology Residents: The Impact of Prior Experience and Laryngoscope Type
An observational study of Learning Curves and Outcomes of Simulation-based Training and Double Lumen Tube Intubation, run by Ankara Ataturk Sanatorium Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Learning Curves and Outcomes of Simulation-based Training, Double Lumen Tube Intubation, Anesthesiology Residency Training
- What is being tested?
- Double lumen tube entubation
- How many people
- 32 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 May 2026to 10 Aug 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: • Being an anesthesiology resident at the Ankara Atatürk Sanatorium Training and Research Hospital
Who may be able to join
- Being an anesthesiology resident at the study institution
- Voluntary participation
Who cannot join
- Refusal to participate in the study
- Prior participation in the same simulation scenario
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Ataturk Sanatorium Training and Research Hospital, Ankara, 06280
Ankara
About this study
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.
Read more
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.
Read the detailed description
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:
- Scenario: Normal airway - Macintosh laryngoscope
- Scenario: Normal airway - Video laryngoscope
- Scenario: Difficult airway - Macintosh laryngoscope
- 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.
- Conditions
- Learning Curves and Outcomes of Simulation-based Training, Double Lumen Tube Intubation, Anesthesiology Residency Training, Experience, Laryngoscopes
- Being tested
- Double lumen tube entubation
- Keywords
- Learning curves, simulation -based training, double lumen tube, experience, laryngoscopes, anesthesiology residents
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Double lumen tube entubationOther
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:
- Scenario: Normal airway - Macintosh laryngoscope
- Scenario: Normal airway - Video laryngoscope
- Scenario: Difficult airway - Macintosh laryngoscope
- Scenario: Difficult airway - Video laryngoscope Participants will complete the scenarios in different sequences, determined by computer-based randomization.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Double lumen tube entubation |
What is being measured
The primary outcome is the main question the study is designed to answer.
• DLT malposition rates 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
Measured: DLT intubation will be completed within 48 hours. The malposition rates within 48 hours will be recorded.
DLT malposition rates 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
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2026
- Study start10 May 2026
- Primary completion10 Aug 2026
- Study completion10 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Learning Curves and Outcomes of Simulation-based TrainingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara Ataturk Sanatorium Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ramazan Baldemir, Ankara Ataturk Sanatorium Training and Research Hospital
- Investigators
- Ramazan BALDEMİR, Principal investigator, ANKARA ATATURK SANATORİUM TRAİNİNG AND RESEARCH HOSPITAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07569107
- Sponsor's protocol ID
- 2024-BÇEK/543
- Status last verified
- May 2026
- First submitted
- 29 Apr 2026
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Learning Curve Analysis of Double-Lumen Tube Placement in Anesthesiology Residents: The Impact of Prior Experience and Laryngoscope Type
- ClinicalTrials.gov ID
- NCT07569107
- Acronym / sponsor ID
- 2024-BÇEK/543
- Conditions
- Learning Curves and Outcomes of Simulation-based Training, Double Lumen Tube Intubation, Anesthesiology Residency Training, Experience, Laryngoscopes
- Keywords
- Learning curves, simulation -based training, double lumen tube, experience, laryngoscopes, anesthesiology residents
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Ankara Ataturk Sanatorium Training and Research HospitalOther government
- Study start
- 10 May 2026 (actual)
- Primary completion
- 10 Aug 2026 (actual)
- Study completion
- 10 Aug 2026 (actual)
- First posted
- 6 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- Scenario: Normal airway - Macintosh laryngoscope
- Scenario: Normal airway - Video laryngoscope
- Scenario: Difficult airway - Macintosh laryngoscope
- 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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Anesthesiology residents with varying levels of experience | – | Other: Double lumen tube entubationAnesthesiology 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- • Being an anesthesiology resident at the Ankara Atatürk Sanatorium Training and Research Hospital
Key inclusion criteria (2 listed)
- Being an anesthesiology resident at the study institution
- Voluntary participation
Key exclusion criteria (2 listed)
- Refusal to participate in the study
- Prior participation in the same simulation scenario
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Double lumen tube entubationAnesthesiology 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. | Other | Anesthesiology residents with varying levels of experience |
Primary outcome
• DLT malposition rates confirmed by fiberoptic bronchoscopy
Time frame: 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 malposition rates confirmed by fiberoptic bronchoscopy
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ramazan BALDEMİR principal investigator
ANKARA ATATURK SANATORİUM TRAİNİNG AND RESEARCH HOSPITAL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Learning Curves and Outcomes of Simulation-based Training and Double Lumen Tube Intubation, run by Ankara Ataturk Sanatorium Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
• DLT malposition rates confirmed by fiberoptic bronchoscopy (time frame: DLT intubation will be completed within 48 hours. The malposition rates within 48 hours will be recorded.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026.