The Comparison of Airway Sealing With the Laryngeal Mask Airway (LMA) Supreme at Different Intracuff Pressure in Children

NCT ID: NCT01738854

Last Updated: 2014-04-08

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

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2013-07-31

Brief Summary

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The laryngeal mask airway (LMA) supreme is a relatively new single-use supraglottic airway with modification. The parameters about airway sealing such as oropharyngeal leak pressure (OLP) and leakage volume are important markers of efficacy and safety when using the supraglottic airway. The airway sealing is related to the intracuff pressure of laryngeal mask airway. The aim of this study is to compare the airway sealing of the LMA supreme at various intracuff pressure in children.

Detailed Description

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Conditions

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General Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

SINGLE

Caregivers

Study Groups

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intra-cuff pressure 40 cmH2O

Group Type EXPERIMENTAL

intracuff pressure by cuff pressure manometer

Intervention Type PROCEDURE

36 patients are randomly allocated according to random sequence of the intracuff pressure 40, 60 and 80 cmH2O. After insertion of LMA supreme, we confirm adequate ventilation. And then we measure OLP and leakage volume at intra-cuff pressure 40, 60 and 80 cmH2O adjusted by cuff pressure manometer according to random sequence of the intracuff pressure.

intra-cuff pressure 60 cmH2O

Group Type ACTIVE_COMPARATOR

intracuff pressure by cuff pressure manometer

Intervention Type PROCEDURE

36 patients are randomly allocated according to random sequence of the intracuff pressure 40, 60 and 80 cmH2O. After insertion of LMA supreme, we confirm adequate ventilation. And then we measure OLP and leakage volume at intra-cuff pressure 40, 60 and 80 cmH2O adjusted by cuff pressure manometer according to random sequence of the intracuff pressure.

intra-cuff pressure 80 cmH2O

Group Type ACTIVE_COMPARATOR

intracuff pressure by cuff pressure manometer

Intervention Type PROCEDURE

36 patients are randomly allocated according to random sequence of the intracuff pressure 40, 60 and 80 cmH2O. After insertion of LMA supreme, we confirm adequate ventilation. And then we measure OLP and leakage volume at intra-cuff pressure 40, 60 and 80 cmH2O adjusted by cuff pressure manometer according to random sequence of the intracuff pressure.

Interventions

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intracuff pressure by cuff pressure manometer

36 patients are randomly allocated according to random sequence of the intracuff pressure 40, 60 and 80 cmH2O. After insertion of LMA supreme, we confirm adequate ventilation. And then we measure OLP and leakage volume at intra-cuff pressure 40, 60 and 80 cmH2O adjusted by cuff pressure manometer according to random sequence of the intracuff pressure.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Pediatric patients (less than 108months of age)
* scheduled for elective surgery undergoing general anesthesia using LMA supreme 1.5-2.5

Exclusion Criteria

* Patients with an abnormal airway,
* reactive airway disease,
* gastroesophageal reflux disease,
* chronic respiratory disease,
* a history of an upper respiratory tract infection
Maximum Eligible Age

9 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Severance hospital

Seoul, Seoul, South Korea

Site Status

Countries

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South Korea

References

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Zhang L, Seet E, Mehta V, Subramanyam R, Ankichetty SP, Wong DT, Chung F. Oropharyngeal leak pressure with the laryngeal mask airway Supreme at different intracuff pressures: a randomized controlled trial. Can J Anaesth. 2011 Jul;58(7):624-629. doi: 10.1007/s12630-011-9514-6. Epub 2011 Apr 30.

Reference Type BACKGROUND
PMID: 21533663 (View on PubMed)

Other Identifiers

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1-2012-0043

Identifier Type: -

Identifier Source: org_study_id

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