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

M

Medical University Innsbruck

Status

Completed

Conditions

Ventilation
Difficult Airway

Treatments

Device: ProSeal LMA

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Sex

Female

Ages

19 to 70 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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