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

NCT00500916 | Completed

• 1 other identifier: UN2532
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Difficult Airway; Ventilation

Outcome Measures

Primary Outcomes (1)

• Insertion success rate

  5 min

Secondary Outcomes (1)

• Time to successful insertion

  5 min

Interventions

ProSeal LMA DEVICE

GEB vs digital vs introducer tool

Eligibility Criteria

• Age: 19 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female patient
• Body mass index \<35 kg/m2
• Difficult airway

You may not qualify if:

• \< 19 yr
• Body mass index \>35 kg/m2
• Risk of aspiration

Sponsors & Collaborators

• Medical University Innsbruck: lead

Study Sites (1)

Department of Anesthesia and Intensive Care

Innsbruck, 6020, Austria

Location

Related Publications (1)

• 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.

  PMID: 18806036 DERIVED

MeSH Terms

Conditions

Respiratory Aspiration

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Christian Keller, MD, M.Sc.

  Dept of Anesthesia and Intensive Care

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 11, 2007
• First Posted: July 13, 2007
• Study Start: March 1, 2007
• Study Completion: December 1, 2007
• Last Updated: December 4, 2007

Record last verified: 2007-12

Locations

AU (1)