Combining Ultrasound Assessment of Sealing Quality With Chemical Monitoring , May Provide Valuable Insights to Compare Effectiveness of Different SADLMANCT07642115

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)

A study testing evaluate the sealing quality (ProSeal LMA)using ultrasonography and a biochemical non invasive test to evaluate regurgitation, evaluate the sealing quality of SGA device ( i-gel)using ultrasonography and a biochemical test for assessment of regurgitation and evaluate the sealing quality of SGA device ( i-gel plus )using ultrasonography and a biochemical test for assessment of regurgitation in people with Combining Ultrasound Assessment of Sealing Quality With Chemical Monitoring , May Provide Valuable Insights to Compare Effectiveness of Different SAD, run by Ain Shams University at 1 site in Egypt.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Combining Ultrasound Assessment of Sealing Quality With Chemical Monitoring , May Provide Valuable Insights to Compare Effectiveness of Different SAD
What is being tested?: evaluate the sealing quality (ProSeal LMA)using ultrasonography and a biochemical non invasive test to evaluate regurgitation, evaluate the sealing quality of SGA device ( i-gel)using ultrasonography and a biochemical test for assessment of regurgitation and evaluate the sealing quality of SGA device ( i-gel plus )using ultrasonography and a biochemical test for assessment of regurgitation
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 105 participants
Where: 1 siteEgypt
Study dates: 12 Nov 2025to Nov 2026
Phase: Interventional
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Egypt1 site

Faculty of medicine ain shams university
Cairo

Other trials in Egypt

About this study

Official title: 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.

Conditions: Combining Ultrasound Assessment of Sealing Quality With Chemical Monitoring , May Provide Valuable Insights to Compare Effectiveness of Different SAD
Being tested: evaluate the sealing quality (ProSeal LMA)using ultrasonography and a biochemical non invasive test to evaluate regurgitation, evaluate the sealing quality of SGA device ( i-gel)using ultrasonography and a biochemical test for assessment of regurgitation, evaluate the sealing quality of SGA device ( i-gel plus )using ultrasonography and a biochemical test for assessment of regurgitation
Keywords: LMA ,SGA , mapping ,OLP, PH ,

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

evaluate the sealing quality (ProSeal LMA)using ultrasonography and a biochemical non invasive test to evaluate regurgitationOther
Also called Sealing assment , anatomical assment , biochemical testing, Proseal LMA
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)using ultrasonography and a biochemical test for assessment of regurgitationOther
Also called I gel sealing
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
Also called I gel plus sealing
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.

Study groups in NCT07642115
Study group	Role	What they receive
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 Receives: 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. Receives: 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. Receives: Other: evaluate the sealing quality of SGA device ( i-gel plus )using ultrasonography and a biochemical test for assessment of regurgitation

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 Nov 2025Nov 2026

First posted11 Jun 2026
Study start12 Nov 2025
Primary completionNov 2026 (estimated)
Study completionNov 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Combining Ultrasound Assessment of Sealing Quality With Chemical Monitoring , May Provide Valuable Insights to Compare Effectiveness of Different SADStudies of the same condition, open and under way.
More trials run by Ain Shams UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Screening
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 105 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07642115
Sponsor's protocol ID: FMASU317/2025
Acronym: LMA
Status last verified: Oct 2025
First submitted: 7 Jun 2026
Last updated: 11 Jun 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

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 at a glance

From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Ultrasonographic Mapping of the Pharyngeal Seal and Its Protective Role for Three Supraglottic Devices (ProSeal LMA, I-gel, and I-gel Plus)
ClinicalTrials.gov ID: NCT07642115
Acronym / sponsor ID: LMA / FMASU317/2025
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 ,
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 105 participants (estimated)
Lead sponsor: Ain Shams UniversityUniversity, hospital or other
Study start: 12 Nov 2025 (actual)
Primary completion: Nov 2026 (estimated)
Study completion: Nov 2026 (estimated)
First posted: 11 Jun 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The findings from this investigation may contribute to improved device selection and enhanced patient safety during procedures requiring supraglottic airway management.

Study design

Primary purpose: Screening
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Group P: ProSeal.	Active comparator	Other: evaluate the sealing quality (ProSeal LMA)using ultrasonography and a biochemical non invasive test to evaluate regurgitationUsing computer-generated random numbers to assign patients to one of the three device groups: First group is Group P: ProSeal
Group I: i-gel.	Active comparator	Other: evaluate the sealing quality of SGA device ( i-gel)using ultrasonography and a biochemical test for assessment of regurgitationUsing computer-generated random numbers to assign patients to one of the three device groups: Second group Group I: i-gel.
Group I+: i-gel Plus.	Active comparator	Other: evaluate the sealing quality of SGA device ( i-gel plus )using ultrasonography and a biochemical test for assessment of regurgitationUsing computer-generated random numbers to assign patients to one of the three device groups: Third group Group I+: i-gel Plus.

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (1 listed)

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.

Key exclusion criteria (2 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
evaluate the sealing quality (ProSeal LMA)using ultrasonography and a biochemical non invasive test to evaluate regurgitationAlso: Sealing assment , anatomical assment , biochemical testing, Proseal LMAThis 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	Group P: ProSeal.
evaluate the sealing quality of SGA device ( i-gel)using ultrasonography and a biochemical test for assessment of regurgitationAlso: I gel sealingThis 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	Group I: i-gel.
evaluate the sealing quality of SGA device ( i-gel plus )using ultrasonography and a biochemical test for assessment of regurgitationAlso: I gel plus sealingThis 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	Group I+: i-gel Plus.

Primary outcome

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).

1 secondary outcome

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

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
BackgroundAhn, 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.
Individual participant dataSharing planned: Undecided

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07642115, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2026.