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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2007-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Difficult Airway Ventilation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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ProSeal LMA

GEB vs digital vs introducer tool

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Responsible Party

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Christian Keller MD, M.Sc.

Principal Investigators

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Christian Keller, MD, M.Sc.

Role: PRINCIPAL_INVESTIGATOR

Dept of Anesthesia and Intensive Care

Locations

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Department of Anesthesia and Intensive Care

Innsbruck, , Austria

Site Status

Countries

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Austria

References

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Eschertzhuber S, Brimacombe J, Hohlrieder M, Stadlbauer KH, Keller C. Gum elastic bougie-guided insertion of the ProSeal laryngeal mask airway is superior to the digital and introducer tool techniques in patients with simulated difficult laryngoscopy using a rigid neck collar. Anesth Analg. 2008 Oct;107(4):1253-6. doi: 10.1213/ane.0b013e31817f0def.

Reference Type DERIVED

PMID: 18806036 (View on PubMed)

Other Identifiers

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UN2532

Identifier Type: -

Identifier Source: org_study_id