Ignite Creation Date:
2024-05-05 @ 6:33 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00500916
Status:
COMPLETED
Last Update Posted:
2007-12-04
First Post:
2007-07-11
Brief Title:
Different Techniques for Insertion of the ProSeal Laryngeal Mask Airway in Patients With Difficult Airway
Sponsor:
Medical University Innsbruck
Organization:
Medical University Innsbruck
Study Overview
Official Title:
Different Techniques for Insertion of the ProSeal Laryngeal Mask Airway in Patients With Difficult Airway
Status:
COMPLETED
Status Verified Date:
2007-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None