The Effect of Ultrasonographic Airway Measurements and Anatomical Differences on Laryngeal Mask Placement in Young and Older Adults

NCT07776847 | Recruiting

• 1 other identifier: 2025/157
• Study Type: observational
• Target: 188
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Airway Management; Laryngeal Mask Airway Insertion Skill

Keywords

Laryngeal mask airway; airway ultrasonography; geriatrics

Outcome Measures

Primary Outcomes (1)

• 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.

  During LMA insertion

Study Arms (2)

young patient

Young adult patients aged 18-40

older patient

Adult patients over the age of 65

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Patient or legally appropriate representative/relative accepts participation as applicable.
• Surgery suitable for LMA placement.
• Age 18-40 years or \>65 years.

You may not qualify if:

• 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

Sponsors & Collaborators

• Duzce University: lead

Study Sites (1)

Duzce University

Düzce, Düzce, Turkey (Türkiye)

RECRUITING

Central Study Contacts

Zennur Güven, Assistant Researcher

CONTACT

+90 5459740213; zennurguven@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ass. Prof.; M.D.

Study Record Dates

• First Submitted: August 17, 2026
• First Posted: August 20, 2026
• Study Start: July 1, 2025
• Primary Completion (Estimated): July 30, 2027
• Study Completion (Estimated): August 30, 2027
• Last Updated: August 24, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)