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

Condition(s) studied

Investigational drug(s) / intervention(s)

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).

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).

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.

Eligibility

Primary outcome measure(s)

• Oropharyngeal Leak Pressure (OPLP) measurement: — after device insertion , 10 minutes later
  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.

Trial sites (1)

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