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)

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07642115

Acronym

LMA

Enrollment

105

Registered

2026-06-11

Start date

2025-11-12

Completion date

2026-11-01

Last updated

2026-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Combining Ultrasound Assessment of Sealing Quality With Chemical Monitoring , May Provide Valuable Insights to Compare Effectiveness of Different SAD

Keywords

LMA ,SGA , mapping ,OLP, PH ,

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.

Interventions

OTHERevaluate 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.

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

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SCREENING

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

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. Pregnancy.

Design outcomes

Primary

Measure	Time frame	Description
Ultrasound mapping of sealing efficacy with correlation to OLP	The primary outcome will be assessed throw the operation time from 2 hours to 4 hours time frame to obtain this outcome.	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).

Secondary

Measure	Time frame	Description
Assessment for Regurgitation and microaspiration	Throw operative time a base line and at the end of operation before emergence of anathesia.	Post insertion of device, place a Salivary Collection Device in the oropharynx via the drainage channel for 5 minutes to collect secretion. Post-operatively A sample of saliva will be collected by the anesthesiologist, and the sample PH will be checked.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 12, 2026