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) (LMA)
June 7, 2026 updated by: Ain Shams University
Ultrasonographic Mapping of the Pharyngeal Seal and Its Protective Role for Three Supraglottic Devices (ProSeal LMA, I-gel, and I-gel Plus)
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 Overview
Status
Active, not recruiting
Intervention / Treatment
- Other: evaluate the sealing quality (ProSeal LMA)using ultrasonography and a biochemical non invasive test to evaluate regurgitation
- Other: evaluate the sealing quality of SGA device ( i-gel)using ultrasonography and a biochemical test for assessment of regurgitation
- Other: evaluate the sealing quality of SGA device ( i-gel plus )using ultrasonography and a biochemical test for assessment of regurgitation
Study Type
Interventional
Enrollment (Estimated)
105
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Cairo, Egypt
- Faculty of medicine ain shams university
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Group P: ProSeal.
Using computer-generated random numbers to assign patients to one of the three device groups: First group is Group P: ProSeal |
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 Names:
|
|
Active Comparator: Group I: i-gel.
Using computer-generated random numbers to assign patients to one of the three device groups: Second group Group I: i-gel. |
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 Names:
|
|
Active Comparator: Group I+: i-gel Plus.
Using computer-generated random numbers to assign patients to one of the three device groups: Third group Group I+: i-gel Plus. |
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 Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Ultrasound mapping of sealing efficacy with correlation to 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.
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Assessment for Regurgitation and microaspiration
Time Frame: 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. |
Throw operative time a base line and at the end of operation before emergence of anathesia.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 12, 2025
Primary Completion (Estimated)
November 1, 2026
Study Completion (Estimated)
November 1, 2026
Study Registration Dates
First Submitted
June 7, 2026
First Submitted That Met QC Criteria
June 7, 2026
First Posted (Actual)
June 11, 2026
Study Record Updates
Last Update Posted (Actual)
June 11, 2026
Last Update Submitted That Met QC Criteria
June 7, 2026
Last Verified
October 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- FMASU317/2025
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.