Oropharyngeal Leak Pressure
Conditions
Brief summary
The Ambu® Aura GainTM is a relatively new 2nd generation Supraglottic Airway Device (SGA) with a second port, providing gastric access to drain gastric content and air and it has an intergrated bite-block that helps avoiding rotation of the SGA. It has been described and it is known from daily routine, that SGA in edentulous patient provide inferior oropharyngeal leak pressure (OLP). The aim of the study is to evaluate if the placement of a gastric tube through the second orifice leads to better OLP and lowers the number of intervention needed for replacing the SGA. The study also evaluates the OLP after 15 minutes and after 30 minutes.
Interventions
DEVICEGastric Tube
SGA is inserted with a gastric tube as guide for insertion
DEVICENo gastric Tube
SGA is inserted without a gastric tube as guide for insertion
Sponsors
Medical University Innsbruck
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
Yes
Inclusion criteria
* ASA I - 3 * Signed informed consent * Age 18 - 90 years * Edentolous (or partial) patients * Patients scheduled for elective surgery
Exclusion criteria
* Patients with a known or predicted difficult airway * Patients with anatomical disorders in the upper airway, the oesophagus or the trachea * Patients at risk for aspiration * Body mass index (BMI) \> 40 kg/m2
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Oropharyngeal Leak Pressure | immediately after insertion | after insertion |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Oropharyngeal Leak Pressure | 15 minutes | after 15 minutes |
Countries
Austria
Outcome results
None listed