- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07776847
The Effect of Ultrasonographic Airway Measurements and Anatomical Differences on Laryngeal Mask Placement in Young and Older Adults
August 21, 2026 updated by: Gizem Demir Şenoğlu, Duzce University
The Effect of Ultrasonographic Airway Measurements and Anatomical Differences on Laryngeal Mask Placement in Young and Older Adults: A Prospective Observational Study
This prospective observational study aims to compare ultrasonographic upper-airway measurements and age-related anatomical differences between young adults (18-40 years) and older adults (>65 years), and to evaluate their effects on laryngeal mask airway (LMA) placement success and position accuracy.
Preoperative airway ultrasonography measurements will be assessed, followed by evaluation of LMA placement, ventilation efficacy, insertion attempts, placement time, and complications.
Ultrasonography will also be used to assess LMA position after placement, with confirmation by leak testing and fiberoptic evaluation.
Preoperative and postoperative gastric volume will additionally be assessed.
Study Overview
Status
Recruiting
Detailed Description
Laryngeal mask airway use is common in general anesthesia.
Age-related anatomical and physiological changes of the upper airway may influence LMA placement in older adults.
The study will prospectively evaluate patients undergoing procedures suitable for LMA placement at Düzce University Faculty of Medicine.
Participants will be divided into young adults (18-40 years) and older adults (>65 years).
Demographic, anthropometric, clinical airway assessment and ultrasonographic airway measurements will be recorded.
Following standardized induction, a ProSeal LMA will be placed by an anesthesia research resident with at least three years of experience.
The number of insertion attempts and placement time will be recorded.
LMA position will be assessed by ultrasonography and compared with leak testing and fiberoptic confirmation.
Ventilation parameters, cuff pressure, LMA position changes, gastric volume and postoperative complications will also be recorded.
Study Type
Observational
Enrollment (Estimated)
188
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Zennur Güven, Assistant Researcher
- Phone Number: +90 5459740213
- Email: zennurguven@gmail.com
Study Locations
-
-
Düzce
-
Düzce, Düzce, Turkey (Türkiye)
- Recruiting
- Düzce University
-
Contact:
- Gizem demir şenoğlu, Ass. Prof
- Phone Number: 05059313588
- Email: gizem123demir@hotmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Adult patients scheduled for elective surgery under general anesthesia with planned laryngeal mask airway use will be enrolled.
The study population will include two age-based groups: young adults aged 18-40 years with ASA physical status I-II, and older adults aged 65 years or above with ASA physical status I-III.
Eligible participants will be patients with intact neck anatomy and clinical suitability for supraglottic airway management.
Patients with BMI >35 kg/m², pregnancy, known obstructive sleep apnea, significant neck deformity or prior diagnostic/therapeutic neck procedures, or mouth opening <2.5 cm will be excluded.
Description
Inclusion Criteria:
- Patient or legally appropriate representative/relative accepts participation as applicable.
- Surgery suitable for LMA placement.
- Age 18-40 years or >65 years.
Exclusion Criteria:
- Pregnancy
- Age <18 years
- History of upper airway surgery
- Gastroesophageal reflux disease, ulcer, or gastrointestinal bleeding history
- Inadequate fasting duration
- Emergency surgery
- Requirement for nasogastric tube placement
- Unstable teeth
- Mouth opening <3 cm
- Recent pulmonary infection
- Recent upper airway infection
- Pulmonary disease associated with increased airway pressures (cystic fibrosis, COPD, interstitial lung disease)
- Restricted cervical movement / inability to achieve required extension
- Ultrasound gel allergy
- Refusal to participate
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
young patient
Young adult patients aged 18-40
|
|
older patient
Adult patients over the age of 65
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
First-attempt successful LMA placement rate
Time Frame: During LMA insertion
|
The primary outcome will compare the proportion of successful first-attempt ProSeal LMA placements between young and older adult groups.
|
During LMA insertion
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2025
Primary Completion (Estimated)
July 30, 2027
Study Completion (Estimated)
August 30, 2027
Study Registration Dates
First Submitted
August 17, 2026
First Submitted That Met QC Criteria
August 17, 2026
First Posted (Actual)
August 20, 2026
Study Record Updates
Last Update Posted (Actual)
August 24, 2026
Last Update Submitted That Met QC Criteria
August 21, 2026
Last Verified
August 1, 2026
More Information
Terms related to this study
Other Study ID Numbers
- 2025/157
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.