I-Gel Versus Disposable Laryngeal Mask (LMA) for General Anesthesia (GA) With Controlled Ventilation
Not Applicable
Completed
- Conditions
- Healthy
- Interventions
- Device: Insertion of laryngeal mask airway (AuraOnce mask)Device: Insertion of I-gel airwayOther: Measurement of airway pressures
- Registration Number
- NCT00668278
- Lead Sponsor
- Northern Health and Social Care Trust
- Brief Summary
Randomized controlled trial comparing performance of the I-gel and disposable Laryngeal Mask Airways under controlled ventilation. 200 patients, 100 in each arm. Measurement of peak airway and sealing pressures. Postoperative questionnaires at 1 and 24hrs.
Hypothesis
There is no difference between the performance\* of the I-gel and disposable laryngeal mask airways for controlled ventilation under general anesthesia.
\*as defined by peak airway pressure and sealing pressures.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 200
Inclusion Criteria
- Males and females.
- Age 18-89 inclusive.
- ASA grade 1-2.
- Elective surgery
Exclusion Criteria
- Emergency surgery.
- Surgery within the peritoneum.
- Surgery requiring prone or steep head-down positioning.
- Patients at increased risk of aspiration
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description A Measurement of airway pressures Laryngeal Mask Airway insertion A Insertion of laryngeal mask airway (AuraOnce mask) Laryngeal Mask Airway insertion B Insertion of I-gel airway I-gel insertion B Measurement of airway pressures I-gel insertion
- Primary Outcome Measures
Name Time Method Sealing pressure and peak airway pressure. Under anaesthesia.
- Secondary Outcome Measures
Name Time Method Postoperative patient symptoms 1hr and 24hrs postoperatively