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).
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
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.
- Conditions
- Laryngeal Mask Airways, Airway Devices
- 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 group | Role | What they receive |
|---|---|---|
| Group Video LMA | Anesthesiology 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.
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.
- First posted10 Jul 2025
- Study start20 May 2025
- Primary completion20 Aug 2025
- Study completion20 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Laryngeal Mask AirwaysStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsun University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hatice Selcuk Kusderci, Study director, Samsun University
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 22329593Nakanishi 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 32447454Nakanishi 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
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Learning Curve of Video Laryngeal Mask Airway (Video-LMA) Use in Airway Management by Anesthesiology Residents: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07057921
- Acronym / sponsor ID
- GOKAEK 2025/11/22
- Conditions
- Laryngeal Mask Airways, Airway Devices
- Keywords
- Third generation supraglottic airway devices, Cumulative Sum learning curves
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Samsun UniversityUniversity, hospital or other
- Study start
- 20 May 2025 (actual)
- Primary completion
- 20 Aug 2025 (actual)
- Study completion
- 20 Oct 2025 (actual)
- First posted
- 10 Jul 2025 (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.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group Video LMA | – | –Anesthesiology residents in training who practice the application of video LMA. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Anesthesiology residents in training who practice the application of video laryngeal mask airway (video LMA).
Key inclusion criteria (1 listed)
- Anesthesiology residents with less than two years of experience and no prior exposure to video laryngeal mask airway (LMA) placement.
Key exclusion criteria (1 listed)
- Having prior hands-on experience with video laryngeal mask airway (LMA) placement
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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 21 Jan 2026.
- Results publication: PubMed 22329593Ragazzi 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.
- Results publication: PubMed 32447454Nakanishi 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.
- Results publication: PubMed 37130901Nakanishi 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.
- Individual participant dataSharing planned: Undecided
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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.
Hatice Selcuk Kusderci study director
Samsun University
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 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.