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

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01003327
• Other study ID #: 354/2009
• Status: Completed
• Phase: Phase 4
• First received: October 27, 2009
• Last updated: July 22, 2010
• Start date: October 2009
• Est. completion date: April 2010

Study information

• Verified date: October 2009
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: April 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Intubation
• Surgery

Intervention

Device:
• I-gel
intubation with I-gel airway
• LMA-Unique
LMA-Unique airway is inserted first, then the I-gel

Locations

Country	Name	City	State
Austria	Medical university of vienna, General hospital of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	leak pressure of the laryngeal masks		directly after insertion of the laryngeal mask	No
Secondary	Insertion time and ease of insertion of the laryngeal mask		during insertion of the laryngeal mask	Yes