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

This study has been completed.
Sponsor:
Information provided by:
Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT01003327
First received: October 27, 2009
Last updated: July 22, 2010
Last verified: October 2009
  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
Device: LMA-Unique
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Comparison of the I-gel Laryngeal Mask and the Classic Laryngeal Mask in Patients With a BMI>25 During Elective Surgery

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 ]

Enrollment: 50
Study Start Date: October 2009
Study Completion Date: April 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
I-gel inserted first
The I-gel airway is insewrted first, then the LMA-Unique
Device: I-gel
intubation with I-gel airway
Other Name: I-gel
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
Other Name: 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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01003327

Locations
Austria
Medical university of vienna, General hospital of Vienna
Vienna, Austria, 1090
Sponsors and Collaborators
Medical University of Vienna
Investigators
Principal Investigator: Ulrike Weber, M.D. Medical University of Vienna
  More Information

No publications provided

Responsible Party: Dr. Ulrike Weber, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT01003327     History of Changes
Other Study ID Numbers: 354/2009
Study First Received: October 27, 2009
Last Updated: July 22, 2010
Health Authority: Austria: Ethikkommission

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

ClinicalTrials.gov processed this record on October 19, 2014