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)

N/AActive Not RecruitingNCT07642115

Ain Shams University105 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SCREENING

Masking

NONE

Enrollment

105

Conditions

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

Interventions

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

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.

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Ultrasound mapping of sealing efficacy with correlation to OLP

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).

Time frame: The primary outcome will be assessed throw the operation time from 2 hours to 4 hours time frame to obtain this outcome.

Secondary Outcomes

Assessment for Regurgitation and microaspiration

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.

Time frame: Throw operative time a base line and at the end of operation before emergence of anathesia.