Supraglottic Airway
Conditions
Brief summary
The study is designed to compare the performance of the Ambu AuraGain Laryngeal Mask Airway and LMA Supreme in normal airway patients.
Detailed 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.
Interventions
DEVICEAmbu AuraGain
DEVICELMA Supreme
Sponsors
Chinese Academy of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Parellel Assignment
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Oropharyngeal leak pressure | Up to 1 minute after the time of confirmed device placement | The airway pressure at which an airway leak is observed after successful placement of the device |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Insertion time | Up to 1 minute on each insertion attempt | Time needed to insert the device |
| Ease of insertion | Up to 1 minute on each insertion attempt | Number of attempts to place the device |
| Fiberoptic Grade of Laryngeal View | Up to 1 minute after placement of device | Fiberoptic Grade of Laryngeal View through each device will be graded using a previously grading system |
| Postoperative Complications | 2 hours after removal of the device | Patient will be evaluated for sore throat, dysphonia, stridor, dysphagia, blood stain on device |
Countries
China
Contacts
Primary ContactLiu Juhui, MD
Outcome results
None listed