Laryngeal Mask Supreme™ Versus the I-gel™

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier:
NCT00653237
First received: April 1, 2008
Last updated: March 11, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Patients Undergoing Elective General Anesthesia
Device: I-gel and LMA Supreme: supraglottic airway devices

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: A Comparison of The Laryngeal Mask Supreme™ and the I-gel™ in a Simulated Difficult Airway Scenario in Anesthetized and Ventilated Patients

Further study details as provided by University Hospital Inselspital, Berne:

Primary Outcome Measures:
  • first attempt success rate and time to success [ Time Frame: during intervention ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • leak pressure [ Time Frame: during intervention ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: March 2008
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1
crossover trial. insertion of both devices consecutively, computer randomized order
Device: I-gel and LMA Supreme: supraglottic airway devices
Insertion of a supraglottic airway device
Other Name: Laryngeal Mask Supreme, supraglottic airway device

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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00653237

Locations
Switzerland
University Hospital
Berne, Switzerland, CH-3010
Sponsors and Collaborators
University Hospital Inselspital, Berne
Investigators
Study Director: Robert Greif, M.D. Department of Anesthesia, University Hospital Berne, Switzerland
  More Information

No publications provided

Responsible Party: University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier: NCT00653237     History of Changes
Other Study ID Numbers: igellma-1
Study First Received: April 1, 2008
Last Updated: March 11, 2014
Health Authority: Switzerland: Federal Office of Public Health

ClinicalTrials.gov processed this record on October 01, 2014