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

ConditionsSupraglottic Airway DevicesLaryseal Clear Laryngeal Mask
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age3-6
SponsorZagazig University

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Emergency surgeries.

Expected difficult airway.

Patients with congenital or acquired airway malformations.

Patients with active upper respiratory tract infection at the time of surgery.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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).

  • 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).

Treatment groups

54 Participants
are divided into 2 treatment groups
Group A: Group L (LarySeal clear Group)Active comparator 1 intervention
Group B: Group A (Ambu Aura40 Group)Active comparator 1 intervention

Trial outcomes

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.

Time frame
after device insertion , 10 minutes later

Secondary outcomes

1

Time for SGAD insertion

the duration from picking up the LMA to obtaining a capnography tracing.

Time frame
periprocedural
2

Ease of device placement

A subjective scale of (1-4) will be used to assess ease of placement 1. = no resistance 2. = mild resistance 3. = moderate resistance 4. = inability to place the device.

Time frame
periprocedural
3

Complication related to the SGAD

Any complication related to device will be recorded during recovery such as coughing, laryngospasm, airway obstruction, hypoxia (SpO2\<92%), suspicion of regurgitation (presence of gastric fluid in the ventilation tube), blood staining on the removed device, and any dental, tongue or lip trauma. Postoperative complications such as dysphagia or hoarseness of voice will be evaluated at PACU and 24 hours after surgery by an observer unaware of the patient's group.

Time frame
at PACU, 24 hour
4

Number of manipulations

Number of manipulations needed to adjust the device position

Time frame
periprocedural

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Zagazig University

Lead sponsor

Source ClinicalTrials.gov
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