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

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

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.

Study Overview

• Status: Completed
• Conditions: Surgery; Intubation
• Intervention / Treatment: Device: I-gel; Device: LMA-Unique

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 Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 4

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria, 1090
    • Medical university of vienna, General hospital of Vienna

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: I-gel inserted first; The I-gel airway is insewrted first, then the LMA-Unique	Device: I-gel; intubation with I-gel airway
Other: LMA-Unique inserted first; LMA-Unique airway is inserted first, then the I-gel	Device: LMA-Unique; LMA-Unique airway is inserted first, then the I-gel

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
leak pressure of the laryngeal masks	directly after insertion of the laryngeal mask

Secondary Outcome Measures

Outcome Measure	Time Frame
Insertion time and ease of insertion of the laryngeal mask	during insertion of the laryngeal mask

Collaborators and Investigators

• Sponsor: Medical University of Vienna

Study record dates

Study Major Dates

• Study Start: October 1, 2009
• Primary Completion (Actual): March 1, 2010
• Study Completion (Actual): April 1, 2010

Study Registration Dates

• First Submitted: October 27, 2009
• First Submitted That Met QC Criteria: October 27, 2009
• First Posted (Estimate): October 28, 2009

Study Record Updates

• Last Update Posted (Estimate): July 23, 2010
• Last Update Submitted That Met QC Criteria: July 22, 2010
• Last Verified: October 1, 2009

More Information

Terms related to this study

• Keywords: laryngeal mask, leak pressure; leak pressure
• Other Study ID Numbers: 354/2009