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Clinical Trials/NCT07642115
NCT07642115Active, not recruitingNot Applicable

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

Ain Shams University1 site in 1 country105 target enrollmentStarted: November 12, 2025Last updated:
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Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
105
Locations
1
Study OverviewStudy DesignEligibility CriteriaInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Screening
Masking
None

Eligibility Criteria

Ages
18 Years to 55 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •Age 18-55 years ASA physical status I or II, BMI 18-35 kg/m² Scheduled for elective surgery that requires around (2-3 hours) duration requiring general anesthesia with an SGAD.

Exclusion Criteria

  • •History of gastroesophageal reflux disease (GERD) Known or anticipated difficult airway, pathology of the mouth/oropharynx/neck, risk of aspiration.

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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