Airway ManagementNCT07776847
The Effect of Ultrasonographic Airway Measurements and Anatomical Differences on Laryngeal Mask Placement in Young and Older Adults
An observational study of Airway Management and Laryngeal Mask Airway Insertion Skill, run by Duzce University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Airway Management, Laryngeal Mask Airway Insertion Skill
- How many people
- 188 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2025to 30 Aug 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Patient or legally appropriate representative/relative accepts participation as applicable.
- Surgery suitable for LMA placement.
- Age 18-40 years or >65 years.
Who cannot join
- Pregnancy
- Age <18 years
- History of upper airway surgery
- Gastroesophageal reflux disease, ulcer, or gastrointestinal bleeding history
- Inadequate fasting duration
- Emergency surgery
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Duzce University
Düzce, Düzce
Gizem demir şenoğlu, Ass. Prof, 05059313588, gizem123demir@hotmail.com
About this study
Official title: 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.
Read the 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.
- Keywords
- Laryngeal mask airway, airway ultrasonography, geriatrics
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 |
|---|---|---|
| young patient | Young adult patients aged 18-40 | |
| older patient | Adult patients over the age of 65 |
What is being measured
The primary outcome is the main question the study is designed to answer.
First-attempt successful LMA placement rate
The primary outcome will compare the proportion of successful first-attempt ProSeal LMA placements between young and older adult groups.
Measured: During LMA insertion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2026
- Study start1 Jul 2025
- Primary completion30 Jul 2027 (estimated)
- Study completion30 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Airway ManagementStudies 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
- 188 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duzce University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gizem Demir Şenoğlu, Duzce University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07776847
- Sponsor's protocol ID
- 2025/157
- Status last verified
- Aug 2026
- First submitted
- 17 Aug 2026
- Last updated
- 24 Aug 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 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Ultrasonographic Airway Measurements and Anatomical Differences on Laryngeal Mask Placement in Young and Older Adults: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07776847
- Acronym / sponsor ID
- 2025/157
- Keywords
- Laryngeal mask airway, airway ultrasonography, geriatrics
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 188 participants (estimated)
- Lead sponsor
- Duzce UniversityUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 30 Jul 2027 (estimated)
- Study completion
- 30 Aug 2027 (estimated)
- First posted
- 20 Aug 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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| young patient | – | –Young adult patients aged 18-40 |
| older patient | – | –Adult patients over the age of 65 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Patient or legally appropriate representative/relative accepts participation as applicable.
- Surgery suitable for LMA placement.
- Age 18-40 years or >65 years.
Key exclusion criteria (15 listed)
- Pregnancy
- Age <18 years
- History of upper airway surgery
- Gastroesophageal reflux disease, ulcer, or gastrointestinal bleeding history
- Inadequate fasting duration
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
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 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.
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 Airway Management and Laryngeal Mask Airway Insertion Skill, run by Duzce 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 3 inclusion and 15 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: looking for participants now, as of the sponsor's last update on 24 Aug 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zennur Güven, Assistant Researcher (+90 5459740213, zennurguven@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
First-attempt successful LMA placement rate (time frame: During LMA insertion). 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 24 Aug 2026.