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

Ventilation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00500916
• Other study ID #: UN2532
• Status: Completed
• Phase: N/A
• First received: July 11, 2007
• Last updated: December 3, 2007
• Start date: March 2007
• Est. completion date: December 2007

Study information

• Verified date: December 2007
• Source: Medical University Innsbruck
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Federal Ministry for Health and Women
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 19 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Difficult Airway
• Ventilation

Intervention

Device:
• ProSeal LMA
GEB vs digital vs introducer tool

Locations

Country	Name	City	State
Austria	Department of Anesthesia and Intensive Care	Innsbruck

Sponsors (1)

Lead Sponsor	Collaborator
Medical University Innsbruck

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Insertion success rate		5 min	No
Secondary	Time to successful insertion		5 min	No