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

NCT00500916 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL

Last updated 2007-12-04

No results posted yet for this study

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.

Conditions

  • Difficult Airway
  • Ventilation

Interventions

DEVICE

ProSeal LMA

GEB vs digital vs introducer tool

Sponsors & Collaborators

  • Medical University Innsbruck

    lead OTHER

Principal Investigators

  • Christian Keller, MD, M.Sc. · Dept of Anesthesia and Intensive Care

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-03-31
Completion
2007-12-31

Countries

  • Austria

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00500916 on ClinicalTrials.gov