Laryngeal Mask Supreme™ Versus the I-gel™

Insel Gruppe AG, University Hospital Bern

Status: Completed

Conditions: Patients Undergoing Elective General Anesthesia

Treatments: Device: I-gel and LMA Supreme: supraglottic airway devices

Study type: Interventional

Funder types: Other

Identifiers

NCT00653237

igellma-1

Details and patient eligibility

About

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.

Full 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

Enrollment: 60 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: Single Blind

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60 participants in 1 patient group

1

Other group

Description:

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

Treatment:

Device: I-gel and LMA Supreme: supraglottic airway devices