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Comparison of Two Insertion Techniques of Proseal Laryngeal Mask Airway by Unskilled Personnel in Children

NCT01191619 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 134

Last updated 2010-08-31

No results posted yet for this study

Summary

The ProSeal laryngeal mask airway (PLMA) is one of the alternative methods for effective airway management. It is an advanced form of laryngeal mask airway(LMA) with a softer and larger cuff to improve sealing and a drain tube to permit venting of the stomach. However, the larger cuff is more difficult to save space for insertion in the mouth and is more likely to fold over. Particularly, a relatively large tongue, a floppy epiglottis, a cephalad and more anterior larynx and frequent presence of tonsillar hypertrophy may disturb PLMA insertion in pediatric patients. The manufacturer recommends inserting PLMA using digital manipulation or with an introducer, but these techniques have lower success rates compared to those of LMA insertion.

McIvor blade is a tongue retractor with a thin and curved blade and a flat handle. It is used to secure the operating field by pressing tongue during tonsillectomy. The investigators hypothesized that McIvor blade would provide more space in the mouth for PLMA insertion, and therefore it could improve the PLMA insertion as well as reducing injuries to the pharyngeal wall. The investigators compared the success rate and the incidence of complications of the digital technique with those of McIvor blade-guided insertion by unskilled anesthesia residents.

Conditions

  • Airway Management

Interventions

PROCEDURE

McIvor retractor

The Mclvor blade- guided technique (McIvor group) involved the following steps. The PLMA was lubricated on the posterior aspect of the deflated mask with a water-based lubricant. The McIvor blade was fully inserted beneath the tongue of the patients. The tongue was lifted gently with the McIvor blade and PLMA was introduced into a space between the McIvor blade and maxillary incisors holding the bite block of the PLMA. The PLMA was advanced into the hypopharynx until definite resistance was felt and McIvor blade was removed.

Sponsors & Collaborators

  • Seoul National University Bundang Hospital

    lead OTHER

Principal Investigators

  • Jin-Young Hwang, MD · Fellow

Study Design

Allocation
RANDOMIZED
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
9 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-07-31
Primary Completion
2010-12-31
Completion
2010-12-31

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01191619 on ClinicalTrials.gov