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Laryngeal Mask Supreme™ Versus the I-gel™

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00653237
Recruitment Status : Completed
First Posted : April 4, 2008
Last Update Posted : March 12, 2014
Sponsor:
Information provided by (Responsible Party):
University Hospital Inselspital, Berne

Tracking Information
First Submitted Date  ICMJE April 1, 2008
First Posted Date  ICMJE April 4, 2008
Last Update Posted Date March 12, 2014
Study Start Date  ICMJE March 2008
Actual Primary Completion Date July 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 3, 2008)
first attempt success rate and time to success [ Time Frame: during intervention ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 3, 2008)
leak pressure [ Time Frame: during intervention ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Laryngeal Mask Supreme™ Versus the I-gel™
Official Title  ICMJE A Comparison of The Laryngeal Mask Supreme™ and the I-gel™ in a Simulated Difficult Airway Scenario in Anesthetized and Ventilated Patients
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Patients Undergoing Elective General Anesthesia
Intervention  ICMJE Device: I-gel and LMA Supreme: supraglottic airway devices
Insertion of a supraglottic airway device
Other Name: Laryngeal Mask Supreme, supraglottic airway device
Study Arms  ICMJE 1
crossover trial. insertion of both devices consecutively, computer randomized order
Intervention: Device: I-gel and LMA Supreme: supraglottic airway devices
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 3, 2008)
60
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2008
Actual Primary Completion Date July 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00653237
Other Study ID Numbers  ICMJE igellma-1
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Hospital Inselspital, Berne
Study Sponsor  ICMJE University Hospital Inselspital, Berne
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Robert Greif, M.D. Department of Anesthesia, University Hospital Berne, Switzerland
PRS Account University Hospital Inselspital, Berne
Verification Date March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP