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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00500916
Enrollment
0
Registered
2007-07-13
Start date
2007-03-31
Completion date
2007-12-31
Last updated
2007-12-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Difficult Airway, Ventilation

Brief 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.

Interventions

GEB vs digital vs introducer tool

Sponsors

Medical University Innsbruck
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
19 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Insertion success rate5 min

Secondary

MeasureTime frame
Time to successful insertion5 min

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026