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Completed

NCT Number: NCT01003327

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

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Medical university of vienna, General hospital of Vienna

Vienna, State of Vienna, 1090, Austria

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

I-gel

Device

intubation with I-gel airway

LMA-Unique

Device

LMA-Unique airway is inserted first, then the I-gel

Primary outcomes

  1. leak pressure of the laryngeal masks

    Time frame: directly after insertion of the laryngeal mask

Secondary outcomes

  1. Insertion time and ease of insertion of the laryngeal mask

    Time frame: during insertion of the laryngeal mask

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Oct 28, 2009
Registry last updated
Jul 23, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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