NCT03139292

Comparative Evaluation of Ambu AuraGain Laryngeal Mask and Proseal Laryngeal Mask Airway

Comparative Evaluation of Ambu AuraGain Laryngeal Mask and Proseal Laryngeal Mask Airway in Spontaneously Breathing Patients Undergoing Elective Surgery Under General Anaesthesia

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 160 (actual)
• Sponsor: Tata Main Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

Comparison of two different supraglottic airway devices i.e., the ProSeal Laryngeal Mask Airway (PLMA) and Ambu AuraGain, a third generation laryngeal mask Airway.

Detailed description

The study aims to compare the two devices with respect to: Time taken for insertion. Insertion attempts or failed attempt. Oropharyngeal leak pressure Air leak Time taken to pass an orogastric tube Attempts to pass an orogastric tube or failed attempt. Haemodynamic variation Incidence of adverse events like failed insertion, aspiration-regurgitation, hypoxia (SpO2\< 90%), bronchospasm, airway obstruction, gastric insufflation, coughing, gagging, retching, hiccup, coughing during removal, blood staining of the airway device and trauma to tongue, lip, teeth, or gums.

Conditions

• Laryngeal Masks

Interventions

Type	Name	Description
DEVICE	ProSeal Laryngeal Mask Airway	ProSeal Laryngeal Mask Airway was used as the supraglottic device
DEVICE	AmbuAuraGain Laryngeal Mask Airway	AmbuAuraGain Laryngeal Mask Airway was used as the supraglottic device

Timeline

• Start date: 2016-05-01
• Primary completion: 2019-10-01
• Completion: 2019-10-01
• First posted: 2017-05-03
• Last updated: 2019-12-30

Locations

1 site across 1 country: India