A Comparative Study Between Laryseal Pro Extraglottic Device and Ambu Aura Gain Laryngeal Mask as… (NCT06945029) | Clinical Trial Compass
RecruitingNot Applicable
A Comparative Study Between Laryseal Pro Extraglottic Device and Ambu Aura Gain Laryngeal Mask as a Conduit for Fiberoptic Tracheal Intubation in Pediatric Population
Egypt100 participantsStarted 2025-04-15
Plain-language summary
This study aims to compare between Laryseal Pro and Ambu Aura Gain extraglottic devices as conduits for fiberoptic endotracheal intubation regarding time of endotracheal intubation in pediatric population.
Who can participate
Age range
4 Years – 8 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The FOB-guided intubation time using the EAD in seconds