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Comparison of the I-gel Laryngeal Mask and the Classic Laryngeal Mask in Patients With a BMI > 25 During Elective Surgery
This study is currently recruiting participants.
Verified by Medical University of Vienna, October 2009
First Received: October 27, 2009   No Changes Posted
Sponsor: Medical University of Vienna
Information provided by: Medical University of Vienna
ClinicalTrials.gov Identifier: NCT01003327
  Purpose

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.


Condition Intervention Phase
Surgery
Intubation
Device: I-gel laryngeal mask, classic laryngeal mask
Phase IV

Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind (Subject), Active Control, Crossover Assignment, Safety/Efficacy Study
Official Title: Comparison of the I-gel Laryngeal Mask and the Classic Laryngeal Mask in Patients With a BMI>25 During Elective Surgery

Resource links provided by NLM:


Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • leak pressure of the laryngeal masks [ Time Frame: directly after insertion of the laryngeal mask ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Insertion time and ease of insertion of the laryngeal mask [ Time Frame: during insertion of the laryngeal mask ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 50
Study Start Date: October 2009
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: I-gel laryngeal mask, classic laryngeal mask
    intubation with airway device
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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;
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01003327

Locations
Austria
Medical university of vienna, General hospital of Vienna Recruiting
Vienna, Austria, 1090
Contact: Ulrike Weber, M.D.     +43 6766038002     ulrike.weber@meduniwien.ac.at    
Principal Investigator: Ulrike Weber, M.D.            
Principal Investigator: Ulrike Weber, M.D.            
Sponsors and Collaborators
Medical University of Vienna
  More Information

No publications provided

Responsible Party: Medical University of Vienna ( Dr. Ulrike Weber )
Study ID Numbers: 354/2009
Study First Received: October 27, 2009
Last Updated: October 27, 2009
ClinicalTrials.gov Identifier: NCT01003327     History of Changes
Health Authority: Austria: Ethikkommission

Keywords provided by Medical University of Vienna:
laryngeal mask, leak pressure
leak pressure

ClinicalTrials.gov processed this record on February 08, 2010