Laryngeal Mask Supreme™ Versus the I-gel™

NCT ID: NCT00653237

Last Updated: 2014-03-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-03-31
• Study Completion Date: 2008-07-31

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

Conditions

Patients Undergoing Elective General Anesthesia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

1

crossover trial. insertion of both devices consecutively, computer randomized order

Group Type: OTHER

I-gel and LMA Supreme: supraglottic airway devices

Intervention Type: DEVICE

Insertion of a supraglottic airway device

Interventions

I-gel and LMA Supreme: supraglottic airway devices

Insertion of a supraglottic airway device

Intervention Type: DEVICE

Other Intervention Names

Laryngeal Mask Supreme, supraglottic airway device

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert Greif, M.D.

Role: STUDY_DIRECTOR

Department of Anesthesia, University Hospital Berne, Switzerland

Locations

University Hospital

Bern, Canton of Bern, Switzerland

Countries

Switzerland

Other Identifiers

igellma-1

Identifier Type: -

Identifier Source: org_study_id