- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07057921
- Original Trial
The Learning Curve of Video Laryngeal Mask Airway (Video-LMA) Use in Airway Management by Anesthesiology Residents
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.
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Ilkadım
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Samsun, Ilkadım, Turkey (Türkiye)
- Samsun University, Samsun Training and Research Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Anesthesiology residents with less than two years of experience and no prior exposure to video laryngeal mask airway (LMA) placement.
Exclusion Criteria:
- Having prior hands-on experience with video laryngeal mask airway (LMA) placement
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Group Video LMA
Anesthesiology residents in training who practice the application of video LMA.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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.
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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.
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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.
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Hatice Selcuk Kusderci, Samsun University
Publications and helpful links
General 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- GOKAEK 2025/11/22
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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