LarySeal Clear versus Ambu Aura40 airway masks for preschool children

Evaluation of the Clinical Performance of Laryseal Clear Versus Ambu Aura 40 Laryngeal Mask Airway for Preschool Children

This test will see if the LarySeal Clear or the Ambu Aura40 laryngeal mask works better for keeping a secure airway in preschool children having short general anesthesia.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 54 (estimated)
• Ages: 3 Years to 6 Years
• Sex: All
• Sponsor: Zagazig University (Government)
• Locations: 1 site (Zagazig, Sharqia Province)
• Trial ID: NCT07553247 on ClinicalTrials.gov

What this trial studies

Preschool children undergoing elective surgery under general anesthesia will be randomized to receive either the LarySeal Clear or the Ambu Aura40 laryngeal mask as the primary airway device. Approximately 48 participants (24 per group) plus an allowance for dropouts will be enrolled and surgeries are expected to last less than two hours. Device size and insertion will follow manufacturer guidelines, with failed third insertion attempt leading to endotracheal intubation and withdrawal. Key measurements include oropharyngeal leak pressure and standard intraoperative airway and ventilation parameters, with safety monitoring throughout.

Who should consider this trial

Good fit: Preschool children (ASA I–II) with normal airways scheduled for elective procedures under general anesthesia lasting under two hours whose parents or guardians consent are ideal candidates.

Not a fit: Children with expected difficult airways, congenital or acquired airway malformations, active upper respiratory infection, GERD, neuromuscular disorders, or those undergoing emergency surgery are excluded and unlikely to benefit from these results.

Why it matters

Potential benefit: If successful, the trial could identify which mask gives a better airway seal and fewer complications for preschool children during anesthesia.

How similar studies have performed: Prior comparisons of supraglottic airway devices have reported differences in oropharyngeal leak pressures (e.g., Bell et al., Kaur et al.), but direct data specifically in preschool populations are limited.

Eligibility criteria

Inclusion Criteria:

* Consent of patient's parents or guardians of the first degree.
* American Society of Anesthesiologists (ASA) Class I or II.
* BMI: 5-85% of the children of the same age and sex.
* Patients with mallampati grade I, II
* Type of anesthesia: general anesthesia expected to last for less than 2 hours.

Exclusion Criteria:

* Emergency surgeries.
* Expected difficult airway.
* Patients with congenital or acquired airway malformations.
* Patients with active upper respiratory tract infection at the time of surgery.
* Patients with history of gastroesophageal reflux disease (GERD).
* Patients with neuromuscular disorders affecting airway tone or respiratory function.

Where this trial is running

Zagazig, Sharqia Province

• Zagazig university hospitals — Zagazig, Sharqia Province, Egypt (Recruiting)

Study contacts

• Study coordinator: Rania Kamel, MD

Conditions Supraglottic Airway Devices; Laryseal Clear Laryngeal Mask