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

NCT07553247 | Recruiting

• 1 other identifier: ZU-IRB #1456
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Oropharyngeal Leak Pressure (OPLP) measurement:

  The expiratory valve will be closed at 3L/min fresh gas flow and setting the upper pressure limit to 30 cmH2O , and the OPLP will be recorded as the peak airway pressure at which an audible gas leak occurs ( detected by auscultation over the neck just lateral to the thyroid cartilage). Head position will remain unchanged throughout the measurement to avoid variations in OPLP.

  after device insertion , 10 minutes later

Secondary Outcomes (4)

• Time for SGAD insertion

  periprocedural

• Ease of device placement

  periprocedural

• Complication related to the SGAD

  at PACU, 24 hour

• Number of manipulations

  periprocedural

Study Arms (2)

Group L (LarySeal clear Group)

ACTIVE COMPARATOR

The laryseal laryngeal mask will be used as a primary airway management device during the surgical procedure.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.

Device: LarySeal clear Group

Group A (Ambu Aura40 Group)

ACTIVE COMPARATOR

The Ambu Aura40 Laryngeal Mask will be used as a primary airway management device during the surgical procedure. 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.

Device: Ambu Aura40 Group

Interventions

LarySeal clear Group DEVICE

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).

Group L (LarySeal clear Group)

Ambu Aura40 Group DEVICE

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).

Group A (Ambu Aura40 Group)

Eligibility Criteria

• Age: 3 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

Zagazig university hospitals

Zagazig, Sharqia Province, Egypt

RECRUITING

Study Officials

• Amany Abdel Azim, MD

  Zagazig University

  STUDY DIRECTOR

• Tarek Gaafar, MD

  Zagazig University

  STUDY CHAIR

Central Study Contacts

Rania Kamel, MD

CONTACT

+201229927122; ranion8598@gmail.com

Amany Rabie, MBBCH

CONTACT

+201096414799

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2026
• First Posted: April 27, 2026
• Study Start: June 25, 2025
• Primary Completion (Estimated): June 25, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)