Laryngeal Mask Supreme™ Versus the I-gel™

Not Applicable

Completed

• Conditions: Patients Undergoing Elective General Anesthesia

• Registration Number: NCT00653237
• Lead Sponsor: Insel Gruppe AG, University Hospital Bern

Brief Summary

We evaluate two new developed airway devices, which provide patent airway during general anesthesia. In 60 patients undergoing elective general anesthesia, we will simulate a difficult airway by using an extrication device collar). We then place consecutively both airway devices in the mouth and check for ease of insertion and time used.

Detailed Description

The LMA Supreme™ and the I-gel™ are both new developed supraglottic airway devices to provide patent airways during general anesthesia. So far, prospective randomized controlled trials comparing their performance are not yet published. Both devices can be used in difficult airway situations, pre-hospital and in the hospital. In this prospective, randomized, controlled cross-over trial, we are going to evaluate the performance of both devices in a simulated difficult airway scenario using an extrication collar to limit both mouth opening and neck movement. In a maximum total of 60 patients undergoing elective surgery, we will place both airway devices consecutively and ventilate the patients. First attempt success rate and time to success will be recorded. Secondary outcomes include oropharyngeal pressure leak, ease of gastric catheter insertion, adverse events and side effects. Our hypothesis is that no difference exists between the two devices. Our 0-hypothesis is that there is a difference

Study Timeline

• Study Start: 2008-03
• Study First Submitted: 2008-04-01
• Study First Submitted QC: 2008-04-03
• Study First Posted: 2008-04-04
• Primary Completion: 2008-07
• Study Completion: 2008-07
• Status Verified: 2014-03
• Last Update Submitted: 2014-03-11
• Last Update Posted: 2014-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• ASA 1-3 patients undergoing elective operation

Exclusion Criteria

• Not speaking german or refusing to participate
• BMI >35, <50kg
• Planned operation time >4h
• High risk of aspiration
• Cervical spine disease, known difficult airway, mouth opening <20mm
• Upper respiratory tract symptoms in the previous 10 days
• Preoperative sore throat
• Poor dentition with high risk of damage

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
first attempt success rate and time to success	during intervention

Secondary Outcome Measures

Name	Time	Method
leak pressure	during intervention

Trial Locations

Locations (1)

University Hospital; 🇨🇭 Berne, Switzerland