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Laryngeal Mask AirwaysNCT07057921

The Learning Curve of Video Laryngeal Mask Airway (Video-LMA) Use in Airway Management by Anesthesiology Residents

An observational study of Laryngeal Mask Airways and Airway Devices, run by Samsun University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Supraglottic airway devices hold a significant role in modern airway management, and laryngeal mask airway (LMA) devices are widely utilized in clinical anesthesia practice. Recently developed video-assisted LMA systems enable direct visual assessment of device placement and positioning. Read more about this study

Who is it for?
Any age
Conditions the study is for
Laryngeal Mask Airways, Airway Devices
How many people
100 participants
Where
1 siteTurkey (Türkiye)
Study dates
20 May 2025to 20 Oct 2025
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: Anesthesiology residents in training who practice the application of video laryngeal mask airway (video LMA).

Who may be able to join

  • Anesthesiology residents with less than two years of experience and no prior exposure to video laryngeal mask airway (LMA) placement.

Who cannot join

  • Having prior hands-on experience with video laryngeal mask airway (LMA) placement

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Samsun University, Samsun Training and Research Hospital

    Samsun, Ilkadım

Other trials in Turkey (Türkiye)

About this study

Official title: The Learning Curve of Video Laryngeal Mask Airway (Video-LMA) Use in Airway Management by Anesthesiology Residents: A Prospective Observational Study

Supraglottic airway devices hold a significant role in modern airway management, and laryngeal mask airway (LMA) devices are widely utilized in clinical anesthesia practice. Recently developed video-assisted LMA systems enable direct visual assessment of device placement and positioning. This technology not only has the potential to enhance patient safety but also offers an opportunity to optimize the learning process by providing visual feedback during training.

Enhancing the technical proficiency of anesthesia residents in airway management is a fundamental component of their education. However, the contribution of next-generation devices such as video LMAs to the learning process and the characterization of their learning curve have been scarcely addressed in the literature. In this context, a quantitative evaluation of the acquisition process of video-assisted LMA insertion skills may provide valuable insights for both educational strategies and patient safety.

Read the detailed description

Supraglottic airway devices constitute a fundamental component of modern airway management, with laryngeal mask airway (LMA) devices being widely implemented across various clinical anesthesia settings. The advent of video-assisted LMA systems has enabled real-time visual confirmation of device insertion and positioning, thereby enhancing procedural accuracy. Beyond their potential to improve patient safety outcomes, these advanced systems provide a pedagogical advantage by facilitating visual feedback during training, thus supporting the optimization of skill acquisition and educational effectiveness in airway management.

The primary aim of this study is to evaluate the learning curve of anesthesia residents during the placement of video-assisted laryngeal mask airway (video LMA) devices and to objectively assess our routinely implemented training protocol by systematically recording the process. Video-assisted airway devices, particularly video LMA systems, offer several advantages over conventional blind techniques. These advantages include higher success rates of insertion, shorter placement times, direct visual confirmation of proper positioning, and a reduction in airway-related complications. Today, many experts acknowledge that video-assisted techniques represent a new standard in supraglottic airway management with respect to both patient safety and educational utility.

Successful execution of video LMA placement requires the acquisition of three core and interrelated technical skills: obtaining an adequate view during insertion, correctly interpreting the visual information to assess device position, and performing precise manipulation through hand-eye coordination. These competencies are especially crucial for anesthesia residents undergoing training and must be effectively acquired during their educational development.

The use of LMA is common in routine elective surgeries. Video-assisted LMA systems are particularly beneficial in educational settings, as they provide real-time visual feedback for the operator and facilitate instructor-led guidance. Before initiating video LMA applications, residents in our institution undergo structured theoretical and practical training, followed by supervised clinical practice under the guidance of experienced anesthesiologists and academic staff. Through this study, we aim to analyze the learning curves of residents and objectively evaluate the effectiveness of the educational approach.

This study aims to evaluate the learning curves of residents in video laryngeal mask airway (LMA) placement and to objectively assess the effectiveness of the training program. This prospective observational study will be conducted with the participation of anesthesiology and reanimation residents at a university hospital. First- and second-year anesthesia residents with no prior experience in video LMA insertion will be included in the study.

Each participant will perform a predetermined number of video LMA insertions (≥10 cases) in adult patients undergoing elective surgery. For each attempt, success or failure, insertion time, quality of ventilation, and the occurrence of complications such as bleeding or gag reflex will be recorded. Success criteria will be based on standards defined in the literature, and all procedures will be carried out under the supervision of an experienced instructor.

Using the collected data, each participant's learning curve will be analyzed using the Cumulative Sum (CUSUM) method. This will allow for statistical assessment of the number of cases required for the learning process to reach a stable plateau.

Keywords
Third generation supraglottic airway devices, Cumulative Sum learning curves

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07057921
Study groupRoleWhat they receive
Group Video LMAAnesthesiology residents in training who practice the application of video LMA.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Success rate and learning curve in the acquisition of video LMA insertion skills

    Based on the collected data, the learning curve of each participant will be calculated using the CUSUM analysis method. This will allow a statistical evaluation of the number of cases after which the learning process stabilizes and reaches a plateau.

    Measured: From the first video LMA application attempt to the completion of the 10th attempt for each participant, within the data collection period of May 20, 2025, to August 20, 2025.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jul 2025
  2. Study start20 May 2025
  3. Primary completion20 Aug 2025
  4. Study completion20 Oct 2025

Resources

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
Cohort
Time perspective
Prospective
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07057921
Sponsor's protocol ID
GOKAEK 2025/11/22
Status last verified
Jan 2026
First submitted
30 Jun 2025
Last updated
21 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Ragazzi R, Finessi L, Farinelli I, Alvisi R, Volta CA. LMA Supreme vs i-gel--a comparison of insertion success in novices. Anaesthesia. 2012 Apr;67(4):384-8. doi: 10.1111/j.1365-2044.2011.07002.x. Epub 2012 Feb 13.

    PubMed 22329593
  • Nakanishi T, Sakamoto S, Yoshimura M, Toriumi T. A learning curve of LMA(R) ProSeal insertion: a prospective analysis of cumulative sum method. J Anesth. 2020 Aug;34(4):554-560. doi: 10.1007/s00540-020-02790-y. Epub 2020 May 23.

    PubMed 32447454
  • Nakanishi T, Sakamoto S, Yoshimura M, Fujiwara K, Toriumi T. Learning curve of i-gel insertion in novices using a cumulative sum analysis. Sci Rep. 2023 May 2;13(1):7121. doi: 10.1038/s41598-023-34152-5.

    PubMed 37130901

Questions about this trial

What is this clinical trial studying?

An observational study of Laryngeal Mask Airways and Airway Devices, run by Samsun University 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 1 inclusion and 1 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 21 Jan 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?

Success rate and learning curve in the acquisition of video LMA insertion skills (time frame: From the first video LMA application attempt to the completion of the 10th attempt for each participant, within the data collection period of May 20, 2025, to August 20, 2025.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07057921, which also lists 3 linked publications.

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 21 Jan 2026.

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