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)

NCT07642115 | Active Not Recruiting DMC

• 1 other identifier: FMASU317/2025
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

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.

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 ,

Outcome Measures

Primary Outcomes (1)

• 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).

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

Secondary Outcomes (1)

• Assessment for Regurgitation and microaspiration

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

Study Arms (3)

Group P: ProSeal.

ACTIVE COMPARATOR

Using computer-generated random numbers to assign patients to one of the three device groups: First group is Group P: ProSeal

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

Group I: i-gel.

ACTIVE COMPARATOR

Using computer-generated random numbers to assign patients to one of the three device groups: Second group Group I: i-gel.

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

Group I+: i-gel Plus.

ACTIVE COMPARATOR

Using computer-generated random numbers to assign patients to one of the three device groups: Third group Group I+: i-gel Plus.

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

Interventions

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

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.

Also known as: I gel plus sealing

Group I+: i-gel Plus.

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

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.

Also known as: Sealing assment , anatomical assment , biochemical testing, Proseal LMA

Group P: ProSeal.

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

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.

Also known as: I gel sealing

Group I: i-gel.

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Faculty of medicine ain shams university

Cairo, Egypt

Location

Related Publications (1)

• Ahn, J. H., Jeong, J. S., Kang, S. H., Yeon, J. E., Cho, E. A., Choi, G. S., ... & Kim, G. S. (2021). Comparison of intragastric pressure between endotracheal tube and supraglottic airway devices in laparoscopic hepatectomy: A randomized, controlled, non-inferiority study. Medicine, 100(24), e26287. Jung, Y., Jung, S., Yu, S., Jeong, M. A., & Kim, C. L. (2024). Gastric distension and atelectasis after using a supraglottic airway-A case report. Anesthesia and Pain Medicine, 19(3), 261-265. O'Riordan, C., Van De Ven, P., Nelson, J., McCreesh, K., & Clifford, A. (2016). Reliability of a measurement method for the cross-sectional area of the longus colli using real-time ultrasound imaging. Ultrasound, 24(3), 154-162. Solanki, S. L., Johnson, J. E., & Samantaray, A. (2020). Supraglottic airway devices: Placement and pharyngeal seal matters!. Indian Journal of Anaesthesia, 64(8), 649-652. Werner, J., Klementova, O., Bruthans, J., Macoun, J., Gaszynski, T., Henlin, T., ... & Michalek, P. (2024). Evaluation of the i-gel® Plus supraglottic airway device in elective surgery: a prospective international multicentre study. Anaesthesia, 79(12), 1284-1291. Zhang, K., Zhou, M., Zou, Z., Zhu, C., & Jiang, R. (2024). Supraglottic airway devices: a powerful strategy in airway management. American journal of cancer research, 14(1), 16., ISO 690.

  BACKGROUND

MeSH Terms

Interventions

Gels

Intervention Hierarchy (Ancestors)

Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2026
• First Posted: June 11, 2026
• Study Start: November 12, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: June 11, 2026

Record last verified: 2025-10

Locations

EG (1)