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

• Sponsor: Medical University Innsbruck (Other)
• Overall Status: Completed
• CT.gov ID: NCT00500916
• Collaborator: (none)
• Enrollment: 0
• Location: 1
• Duration (Months): 9
• Patients Per Site Per Month: 0

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Difficult Airway; Ventilation	Device: ProSeal LMA	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 0 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Different Techniques for Insertion of the ProSeal Laryngeal Mask Airway in Patients With Difficult Airway
• Study Start Date: Mar 1, 2007
• Actual Study Completion Date: Dec 1, 2007

Outcome Measures

Primary Outcome Measures

1. Insertion success rate [5 min]

Secondary Outcome Measures

1. Time to successful insertion [5 min]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years to 70 Years
• Sexes 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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00500916
• Other Study ID Numbers: UN2532
• First Posted: Jul 13, 2007
• Last Update Posted: Dec 4, 2007
• Last Verified: Dec 1, 2007

Study Results

No Results Posted as of Dec 4, 2007