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NCT07642115
NA

The Use of Ultrasound to Assess the Airway Anatomy Regarding Pharyngeal Seal and Its Protective Role Throw a Chemical Test for Three Supraglottic Devices (ProSeal LMA, I-gel, and I-gel Plus)

Sponsor: Ain Shams University

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to to evaluate the sealing quality of three second-generation SADs (ProSeal LMA, i-gel, and i-gel Plus) using ultrasonography to measure the cross-sectional area (CSA) of sealing, Anterior-Posterior (AP) Diameter and Transverse (TV) Diameter ,percentage of effective sealing , presence of sealing gap and correlate these anatomical findings with oropharyngeal leak pressure (OLP), while simultaneously testing relevant safety features of regurgitation risk through salivary pH measurement. The findings from this investigation may contribute to improved device selection and enhanced patient safety during procedures requiring supraglottic airway management.

Official title: Ultrasonographic Mapping of the Pharyngeal Seal and Its Protective Role for Three Supraglottic Devices (ProSeal LMA, I-gel, and I-gel Plus)

Key Details

Gender

All

Age Range

18 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

105

Start Date

2025-11-12

Completion Date

2026-11

Last Updated

2026-06-11

Healthy Volunteers

Yes

Interventions

OTHER

evaluate the sealing quality (ProSeal LMA)using ultrasonography and a biochemical non invasive test to evaluate regurgitation

This multimodal approach, combining ultrasound assessment of sealing quality with biochemical monitoring of regurgitation, may provide valuable insights into the comparative effectiveness of different SAD designs and ensure patient safety.

OTHER

evaluate the sealing quality of SGA device ( i-gel)using ultrasonography and a biochemical test for assessment of regurgitation

This multimodal approach, combining ultrasound assessment of sealing quality with biochemical monitoring of regurgitation, may provide valuable insights into the comparative effectiveness of different SAD designs and ensure patient safety.

OTHER

evaluate the sealing quality of SGA device ( i-gel plus )using ultrasonography and a biochemical test for assessment of regurgitation

This multimodal approach, combining ultrasound assessment of sealing quality with biochemical monitoring of regurgitation, may provide valuable insights into the comparative effectiveness of different SAD designs and ensure patient safety.

Locations (1)

Faculty of medicine ain shams university

Cairo, Egypt