Different Techniques for Insertion of the ProSeal Laryngeal Mask Airway in Patients With Difficult Airway

This study has been completed.
Sponsor:
Information provided by:
Medical University Innsbruck
ClinicalTrials.gov Identifier:
NCT00500916
First received: July 11, 2007
Last updated: December 3, 2007
Last verified: December 2007
  Purpose

The ProSeal laryngeal mask airway (PLMA) is a new laryngeal mask device with a modified cuff to improve the seal and a drain tube to prevent aspiration and gastric insufflation. The manufacturer recommends inserting the PLMA using digital manipulation, like the Classic LMA, or with an introducer tool (IT), like the Intubating LMA. The mean (range) frequency of insertion success at the first attempt for these techniques is 84% (81-100) and 95% (90-100) respectively, with the main causes of insertion difficulty being impaction at the back of the mouth and failure of the distal cuff to reach the hypopharynx. Howarth et al described an insertion technique which overcomes these difficulties by using a gum elastic bougie (GEB) placed in the esophagus to guide the PLMA around the back of the mouth and into its correct position in the hypopharynx. Howarth et al reported no failed uses from 100 consecutive insertions. In the following study, we test the hypothesis that GEB-guided insertion is more frequently successful than the digital and IT techniques in patients with difficult airway.


Condition Intervention
Difficult Airway
Ventilation
Device: ProSeal LMA

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Different Techniques for Insertion of the ProSeal Laryngeal Mask Airway in Patients With Difficult Airway

Further study details as provided by Medical University Innsbruck:

Primary Outcome Measures:
  • Insertion success rate [ Time Frame: 5 min ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to successful insertion [ Time Frame: 5 min ] [ Designated as safety issue: No ]

Estimated Enrollment: 0
Study Start Date: March 2007
Study Completion Date: December 2007
Intervention Details:
    Device: ProSeal LMA
    GEB vs digital vs introducer tool
  Eligibility

Ages Eligible for Study:   19 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Female patient
  • 19-70 yr
  • Body mass index <35 kg/m2
  • Difficult airway

Exclusion Criteria:

  • < 19 yr
  • Body mass index >35 kg/m2
  • Risk of aspiration
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00500916

Locations
Austria
Department of Anesthesia and Intensive Care
Innsbruck, Austria, 6020
Sponsors and Collaborators
Medical University Innsbruck
Investigators
Principal Investigator: Christian Keller, MD, M.Sc. Dept of Anesthesia and Intensive Care
  More Information

No publications provided by Medical University Innsbruck

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Medical University Innsbruck, Christian Keller MD, M.Sc.
ClinicalTrials.gov Identifier: NCT00500916     History of Changes
Other Study ID Numbers: UN2532
Study First Received: July 11, 2007
Last Updated: December 3, 2007
Health Authority: Austria: Federal Ministry for Health and Women

ClinicalTrials.gov processed this record on July 23, 2014