Comparing two devices for easier intubation in children
Official title: A Comparative Study Between Laryseal Pro Extraglottic Device and Ambu Aura Gain Laryngeal Mask as a Conduit for Fiberoptic Tracheal Intubation in Pediatric Population: A Prospective Randomized Controlled Study
Run by Cairo University · NCT06945029 · Data updated 2026-11-12
This study tests which of two devices makes it easier and quicker to help children breathe during surgery when they need a tube put in their throat.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 4 Years to 8 Years |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Cairo University Academic / other |
| Locations | 1 site (Cairo, Giza Governorate) |
| Status | Recruiting |
| Started | April 15, 2025 |
| Main results expected | December 1, 2025 |
| Study ends | April 1, 2026 |
| Registry record updated | April 25, 2025 |
| Trial ID | NCT06945029 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are children aged 4 to 8 years scheduled for day case surgeries under general anesthesia with no suspected difficult airway.
✕Probably not a fit
Patients with craniofacial anomalies, active respiratory or cardiac diseases, or those at risk of regurgitation may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study compares the effectiveness of the Laryseal Pro and Ambu Aura Gain extraglottic devices as conduits for fiberoptic endotracheal intubation in pediatric patients. It focuses on measuring the time taken for successful intubation using these devices during general anesthesia for day case surgeries. The study aims to enhance airway management techniques by evaluating which device provides better outcomes in terms of safety and efficiency. By utilizing fiberoptic bronchoscopy-guided intubation, the study seeks to minimize complications associated with difficult airway scenarios in children.
Why it matters
Potential benefit: If successful, this study could improve the safety and efficiency of intubation procedures in pediatric patients.
How similar studies have gone: Previous studies have shown the effectiveness of similar extraglottic devices in airway management, indicating potential for success in this comparative approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age starting from 4 years to 8 years. * Both genders. * ASA physical status class I-ll. * Apparently anatomically normal with normal percentile growth chart, not suspected to have difficult airway. * Scheduled for day case surgeries more than one hour under general anesthesia. Exclusion Criteria: * Parents refusal. * Abnormality in head and neck or craniofacial anomalies as Piere Robbin syndrome, facial trauma, head and neck tumours, swellings and hemangiomas. * Patients at risk of regurgitation and pulmonary aspiration such as patients with hiatus hernia, GERD or DM. * Abnormal or contraindicated cervical spine flexion/extension/rotation. * Allergy to any EAD components. * Any active respiratory or cardiac disease and metabolic disorders.
Where it's running
-
Faculty of Medicine, Cairo University
Cairo, Giza Governorate, Egypt Recruiting
Study contacts
- Study coordinator: Omnia Y Kamel, Doctorate degree
- Email: omniayehiakamel90@gmail.com
- Phone: 01270130326
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.