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NCT Number: NCT07776847

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Duzce University

Düzce, Turkey (Türkiye)

Location status: Recruiting

Location contact

Gizem demir şenoğlu, Ass. Prof

CONTACT

[email protected]

05059313588

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Zennur Güven, Assistant Researcher

CONTACT

[email protected]

+90 5459740213

Sponsors and collaborators

Lead sponsor

Duzce University

Other

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Aug 20, 2026
Registry last updated
Aug 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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