NCT05106478

AuraGain Performance in Lateral Position

A Randomized Comparison of Pediatric® AuraGain in Supine, Moderate Lateral, and Extreme Lateral Positions in Terms of Clinical Performance and Fiber Optic Glottic

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 52 (actual)
• Sponsor: Assiut University · Academic / Other
• Sex: All
• Age: 2 Years – 9 Years
• Healthy volunteers: Not accepted

Summary

To compare the clinical performance of AuraGain including insertion time and success rate at first attempt, fiberoptic bronchoscopic view, oropharyngeal leak pressure, the degree of ease of gastric tube insertion, and peri-operative adverse effects in young children in supine, moderate lateral and extreme lateral position.

Detailed description

Ambu® AuraGain, a relatively novel supraglottic airway device, has been introduced recently. AuraGain has an inflatable cuff and a curved body. In addition, because the airway tube of AuraGain is wide, it can be used as a conduit for tracheal intubation. However, only a limited number of studies have been conducted on the performance of AuraGain in pediatric patients. Changes in the position of the head and neck alter the shape of the pharynx leading to changes in the oropharyngeal leak pressure and the quality of ventilation through the LMA in both the adult and pediatric population. Having a large occiput and a relatively cephalically placed glottis, the ventilation in children is more compromised due to poor alignment of the pharyngeal-laryngeal axes during flexion of the head and neck. The hanging epiglottis covers the laryngeal inlet during flexion and the cuff of the LMA compresses the narrow laryngeal inlet both decreasing the delivered tidal volume. Different changes occur during extension and lateral rotation Although the clinical performance of the AuraGain would be expected to be high, or at least non-inferior, to that of the widely used currently available SGAs, clinical trials are required to verify its performance in head and neck positions other than the neutral position (i.e flexion, extension and lateral rotation).

Conditions

• Airway Complication of Anesthesia

Interventions

Type	Name	Description
DEVICE	AuraGain	Ambu® AuraGain, a relatively novel supraglottic airway device, has been introduced recently. AuraGain has an inflatable cuff and a curved body.

Timeline

• Start date: 2021-11-01
• Primary completion: 2023-10-01
• Completion: 2023-12-29
• First posted: 2021-11-03
• Last updated: 2024-01-17

Locations

1 site across 1 country: Egypt