Laryngeal Mask Supreme™ Versus the I-gel™

Patients Undergoing Elective General Anesthesia Clinical Trial

Official title:

A Comparison of The Laryngeal Mask Supreme™ and the I-gel™ in a Simulated Difficult Airway Scenario in Anesthetized and Ventilated Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00653237
• Other study ID #: igellma-1
• Status: Completed
• Phase: N/A
• First received: April 1, 2008
• Last updated: March 11, 2014
• Start date: March 2008
• Est. completion date: July 2008

Study information

• Verified date: March 2014
• Source: University Hospital Inselspital, Berne
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Federal Office of Public Health
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Patients Undergoing Elective General Anesthesia

Intervention

Device:
• I-gel and LMA Supreme: supraglottic airway devices
Insertion of a supraglottic airway device

Locations

Country	Name	City	State
Switzerland	University Hospital	Berne

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Inselspital, Berne

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	first attempt success rate and time to success		during intervention	Yes
Secondary	leak pressure		during intervention	No