Comparative Evaluation of Ambu AuraGain, LarySeal Pro and I-gel in Pediatric Airway Management for Day-Case Surgery Under Controlled Ventilation
NCT ID: NCT07274280
Last Updated: 2025-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NOT_YET_RECRUITING
NA
165 participants
INTERVENTIONAL
2026-01-01
2026-07-15
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
* Group I: Ambu® AuraGain TM (Ambu Ltd Xiang Yu Xiamen, Fujian, China)
* Group II: LarySeal Pro® LMA (Flexicare Medical Limited, Cynon Valley Business Park, Mountain Ash, UK).Patients will receive oral midazolam before anesthesia, followed by standard monitoring, induction with sevoflurane, fentanyl, and atracurium, and insertion of an appropriately sized SGAD by experienced anesthesiologists. Ventilation quality, oropharyngeal leak pressure (OLP), peak airway pressure (Ppeak), fiberoptic glottic view, and gastric insufflation by ultrasound will be assessed. Anesthesia will be maintained with controlled ventilation and cuff pressure adjusted to 60 cmH₂O. At the end, neuromuscular blockade will be reversed, devices removed upon awakening, and patients observed for complications such as laryngospasm, Outcome parameter (s):
* Oropharyngeal Leak Pressure (OLP).
* Demographic and Clinical Data.
* Hemodynamics.
* Insertion Data.
* Peak Airway Pressure (Ppeak).
* Fiberoptic Glottic View Assessment.
* Ultrasound Assessment of Gastric Insufflation.
* Perioperative Complications.bronchospasm, or sore throat.
* Group III: I-gelTM (Intersurgical Ltd, Berkshire, RG41 2RZ, UK).
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
DIAGNOSTIC
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Group I: Ambu AuraGain LMA
supraglottic Airway device used for airway control
supraglottic airway device
use of supraglottic airway device as an airway control device for pediatric patients during day case surgery under controlled ventilation
Group II: LarySeal Pro LMA
supraglottic airway device used for airway control
supraglottic airway device
use of supraglottic airway device as an airway control device for pediatric patients during day case surgery under controlled ventilation
Group III: I-gel
supraglottic airway device used for airway control
supraglottic airway device
use of supraglottic airway device as an airway control device for pediatric patients during day case surgery under controlled ventilation
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
supraglottic airway device
use of supraglottic airway device as an airway control device for pediatric patients during day case surgery under controlled ventilation
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Weight 10-30 kg.
* ASA Physical Status I or II.
* Elective day-case surgery requiring general anesthesia with controlled ventilation using an SGAD.
* Written informed consent from parent(s) or legal guardian(s).
Exclusion Criteria
* Known or predicted difficult airway.
* History of significant respiratory disease (e.g., asthma requiring frequent medication, active upper respiratory tract infection, reactive airway disease within the past month).
* History of significant gastroesophageal reflux, hiatal hernia, BMI ≥ 35, or other conditions predisposing to increased aspiration risk.
* Neuromuscular disorders affecting airway patency or respiratory function.
* Known allergy or contraindication to study devices or anesthetic medications.
* Participation in other clinical trials that could influence study outcomes.
2 Years
9 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Kasr El Aini Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Emad Mohamed Ahmed Abdelhafez
Lecturer of Anesthesia, Surgical Intensive Care and Pain Management
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
KasrAlainy Hospitals
Cairo, , Egypt
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Related Links
Access external resources that provide additional context or updates about the study.
educational and academic web page
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
N-288-2025
Identifier Type: -
Identifier Source: org_study_id