Different Techniques for Insertion of the ProSeal Laryngeal Mask Airway in Patients With Difficult Airway
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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 |
- Insertion success rate [ Time Frame: 5 min ] [ Designated as safety issue: No ]
- 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 |
-
Device: ProSeal LMA
Eligibility| Ages Eligible for Study: | 19 Years to 70 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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| Austria | |
| Department of Anesthesia and Intensive Care | |
| Innsbruck, Austria, 6020 | |
| 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 June 17, 2013