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Clinical Trials/NCT01003327
NCT01003327
Completed
Phase 4

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

Medical University of Vienna1 site in 1 country50 target enrollmentOctober 2009

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Surgery
Sponsor
Medical University of Vienna
Enrollment
50
Locations
1
Primary Endpoint
leak pressure of the laryngeal masks
Status
Completed
Last Updated
15 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 2009
End Date
April 2010
Last Updated
15 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

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;

Outcomes

Primary Outcomes

leak pressure of the laryngeal masks

Time Frame: directly after insertion of the laryngeal mask

Secondary Outcomes

  • Insertion time and ease of insertion of the laryngeal mask(during insertion of the laryngeal mask)

Study Sites (1)

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