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Sponsored by: |
Medical University Innsbruck |
Information provided by: | Medical University Innsbruck |
ClinicalTrials.gov Identifier: | NCT00500916 |
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: | Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Different Techniques for Insertion of the ProSeal Laryngeal Mask Airway in Patients With Difficult Airway |
Estimated Enrollment: | 0 |
Study Start Date: | March 2007 |
Study Completion Date: | December 2007 |
Ages Eligible for Study: | 19 Years to 70 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Austria | |||||
Department of Anesthesia and Intensive Care | |||||
Innsbruck, Austria, 6020 |
Medical University Innsbruck |
Principal Investigator: | Christian Keller, MD, M.Sc. | Dept of Anesthesia and Intensive Care |
Principal Investigator: | Christian Keller, MD, M.Sc. | Dept of Anesthesia and Intensive Care |
Responsible Party: | Christian Keller MD, M.Sc. ( Medical University Innsbruck ) |
Study ID Numbers: | UN2532 |
First Received: | July 11, 2007 |
Last Updated: | December 3, 2007 |
ClinicalTrials.gov Identifier: | NCT00500916 |
Health Authority: | Austria: Federal Ministry for Health and Women |