A Comparison of the Ambu®AuraGain™ and the Laryngeal Mask Airway Supreme™ in Normal Airway Patients

Chinese Academy of Medical Sciences & Peking Union Medical College

Status: Unknown

Conditions: Supraglottic Airway

Treatments: Device: Ambu AuraGain; Device: LMA Supreme

Study type: Interventional

Funder types: Other

Identifiers

NCT03108391

PSH-2016-8

Details and patient eligibility

About

The study is designed to compare the performance of the Ambu AuraGain Laryngeal Mask Airway and LMA Supreme in normal airway patients.

Full description

Ambu AuraGain Laryngeal Mask Airway is a newly designed supraglottic device. We design this study to test its clinical performance in normal airway patients, in comparison with LMA Supreme.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• American Society of Anesthesiologists Ⅰ-Ⅲ classification
• Patients evaluated as eligible for a LMA
• Body Mass Index ≤35kg/m2

Exclusion criteria

• Patients with known or predicted difficult airway
• Active respiratory infection
• Risk of aspiration
• Head and neck surgery
• Emergent surgery

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

100 participants in 2 patient groups

Ambu AuraGain

Experimental group

Description:

Subjects will receive the Ambu AuraGain size 3 to size 5 based on manufacturer guidelines

Treatment:

Device: Ambu AuraGain

LMA Supreme

Active Comparator group

Description:

Subjects will receive the LMA Supreme size 3 to size 5 based on manufacturer guidelines

Treatment:

Device: LMA Supreme