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

Phase 4

Completed

• Conditions: Surgery; Intubation
• Interventions: Device: I-gel; Device: LMA-Unique

• Registration Number: NCT01003327
• Lead Sponsor: Medical University of Vienna

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.

Study Timeline

• Status Verified: 2009-10
• Study Start: 2009-10
• Study First Submitted: 2009-10-27
• Study First Submitted QC: 2009-10-27
• Study First Posted: 2009-10-28
• Primary Completion: 2010-03
• Study Completion: 2010-04
• Last Update Submitted: 2010-07-22
• Last Update Posted: 2010-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
I-gel inserted first	I-gel	The I-gel airway is insewrted first, then the LMA-Unique
LMA-Unique inserted first	LMA-Unique	LMA-Unique airway is inserted first, then the I-gel

Primary Outcome Measures

Name	Time	Method
leak pressure of the laryngeal masks	directly after insertion of the laryngeal mask

Secondary Outcome Measures

Name	Time	Method
Insertion time and ease of insertion of the laryngeal mask	during insertion of the laryngeal mask

Trial Locations

Locations (1)

Medical university of vienna, General hospital of Vienna; 🇦🇹 Vienna, Austria