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OpenTrials
Completed

NCT Number: NCT00500916

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

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.

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Key information

Age range

19 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Department of Anesthesia and Intensive Care

Innsbruck, 6020, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Proseal LMA

Device

GEB vs digital vs introducer tool

Primary outcomes

  1. Insertion success rate

    Time frame: 5 min

Secondary outcomes

  1. Time to successful insertion

    Time frame: 5 min

Sponsors and collaborators

Lead sponsor

Medical University Innsbruck

Other

Registry information

Important dates

Study start
2007
Study completion
2007
First posted
Jul 13, 2007
Registry last updated
Dec 4, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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