MedTrace Logo

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

NCT07553247 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2026-04-30

No results posted yet for this study

Summary

Preschool children have specific anatomical and physiological characteristics which necessitates careful selection of an appropriate airway management device. Supraglottic airway devices can be used in anticipated or unanticipated difficult airway providing continuous oxygenation and ventilation with less hemodynamic stress response and less postoperative complications. So alternative techniques such as SADs have gained prominence in pediatric anesthesia both as primary airway and as a conduit for endotracheal intubation. So this study will evaluate the clinical performance of Laryseal Clear and Ambu Aura40 laryngeal mask airway in preschool children undergoing surgical procedures.

Conditions

  • Supraglottic Airway Devices
  • Laryseal Clear Laryngeal Mask

Interventions

DEVICE

LarySeal clear Group

Patient's airway will be secured with the LarySeal laryngeal mask. Selection of the LMA size will be based on the body weight of the patient (Bennett et al., 1996). The device will be lubricated by a water-based jelly before placement. The head of the patient will be placed in the dorsiflexion sniffing position and a lubricated LMA of appropriate size (LarySeal, Flexicare medical Ltd., UK) will be inserted using the index finger digital method technique according to manufacturers guideline. To ensure optimal inflation of SGAD cuff, it will be inflated with a volume of air according to the manufacturer's guidance (7 ml for size 1.5, 10 ml for size 2, 14 ml for size 2.5, and 20 ml for size 3).

DEVICE

Ambu Aura40 Group

Patient's airway will be secured with the Ambu Aura40 laryngeal mask.Selection of the LMA size will be based on the body weight of the patient. The device will be lubricated by a water-based jelly before placement. Patient's head will be in neutral position, a lubricated Ambu® Aura40(Ambu A/S, Copenhagen, Denmark) of appropriate size will be inserted using the non rotational midline approach according to manufacturer's guideline. To ensure optimal inflation of SGAD cuff, it will be inflated with a volume of air according to the manufacturer's guidance (7 ml for size 1.5, 10 ml for size 2, 14 ml for size 2.5, and 20 ml for size 3).

Sponsors & Collaborators

  • Zagazig University

    lead OTHER_GOV

Principal Investigators

  • Amany Abdel Azim, MD · Zagazig University

  • Tarek Gaafar, MD · Zagazig University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
6 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-25
Primary Completion
2026-06-25
Completion
2026-07-01

Countries

  • Egypt

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07553247 on ClinicalTrials.gov