Comparison of the I-gel Laryngeal Mask and the Classic Laryngeal Mask in Patients With a BMI>25

NCT ID: NCT01003327

Last Updated: 2010-07-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-10-31
• Study Completion Date: 2010-04-30

Brief Summary

The intention of this study is to compare the performance of the single-use I-gel laryngeal mask with the classic laryngeal mask in 50 patients with a BMI>25 during elective surgery. Primary outcome is the leak pressure. Secondary outcomes include ease and duration of insertion.

Detailed Description

Inclusion criteria of this randomized cross-over study are: BMI > 25, elective surgery in supine position, age>18 years, ASA I-II; Exclusion criteria are: difficult airway, pregnancy, history of reflux or gastrointestinal disorders, abdominal or thoracic surgery; In this cross-over trial both airway devices are inserted in the same patient, the order of insertion is randomized. Patient receive monitoring with blood pressure, ECG and pulse oxymetry during operation. Anaesthesia is induced intravenously using fentanyl (0.001 mg/kg) and propofol (3-5 mg/kg). The I-gel laryngeal mask is inserted with a gastric tube. The classic laryngeal mask was cuffed after insertion with a cuff pressure of 60 cmH2O. The first device is removed 5 minutes after insertion and replaced by the second device. Ease of insertion is graded as very easy=1, easy=2, difficult=3 and very difficult=4. Leak pressure is measured by two tests: In the first test the spill valve is closed at a fresh gas flow of 6l/min and the minimum airway pressure at which gas leaked around the airway device is recorded by listening for an audible leak. In the second test leakage is measured during pressure controlled ventilation. Therefore we administer a fresh gas flow of 3l/min, FiO2 of 50%, inspiration to expiration ratio of 1:2 and a frequency of breathing of 12. Leakage can be measured by the respirator. We record inspiration pressure, mean pressure, plateau pressure, tidal volume and peep at which the first measurable leakage occurred.

For statistical analysis we will use t-tests with a power of 80% and a p < 0.05.

Conditions

Surgery; Intubation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

I-gel inserted first

The I-gel airway is insewrted first, then the LMA-Unique

Group Type: OTHER

I-gel

Intervention Type: DEVICE

intubation with I-gel airway

LMA-Unique inserted first

LMA-Unique airway is inserted first, then the I-gel

Group Type: OTHER

LMA-Unique

Intervention Type: DEVICE

LMA-Unique airway is inserted first, then the I-gel

Interventions

I-gel

intubation with I-gel airway

Intervention Type: DEVICE

LMA-Unique

LMA-Unique airway is inserted first, then the I-gel

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• BMI > 25, elective surgery in supine position,
• age > 18 years,
• ASA I-II;

Exclusion Criteria

• difficult airway, pregnancy,
• history of reflux or gastrointestinal disorders,
• abdominal or thoracic surgery;

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of Vienna

OTHER

Sponsor Role: lead

Responsible Party

Medical University of Vienna

Principal Investigators

Ulrike Weber, M.D.

Role: PRINCIPAL_INVESTIGATOR

Medical University of Vienna

Locations

Medical university of vienna, General hospital of Vienna

Vienna, Vienna, Austria

Countries

Austria

Other Identifiers

354/2009

Identifier Type: -

Identifier Source: org_study_id