A Method to Determine the Size of Laryngeal Mask Airway (LMA)

October 1, 2014 updated by: Murat Haliloglu, Yeditepe University Hospital

A Simple Method to Determine the Size of the ProSeal LMA (PLMA) in Children

After institutional ethics board approval and written informed consent from parents, 197 children scheduled for routine genitourinary operation and in whom a LMA was indicated for anesthesia were included in the study. The size of the LMA was determined by choosing the size that was best matched with the auricle of the children. The results were compared with the standard method recommended by the manufacturer's weight-related guidelines. The patients were classified in different groups depending on the PLMA sizes determined by both methods. A kappa coefficient evaluated the agreement between both techniques.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

197

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Kozyatağı
      • İstanbul, Kozyatağı, Turkey, 34752
        • Yeditepe University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 15 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • ASA physical status I/II
  • scheduled for genitourinary operation
  • LMA was indicated for anesthesia

Exclusion Criteria:

  • surgery lasting more than 3 h
  • overweight or underweight patients
  • gastroesophageal reflux
  • risk of aspiration
  • airway infection in the last six weeks
  • decreased pulmonary or chest wall compliance.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Ear-sized based and weight based formula
the sizes of the PLMA determined with the ear-based compared with the sizes according to the manufacturer's weight-based formula
Device: Ear-sized based
the sizes of the PLMA determined with the ear-based formula were compared with the sizes according to the manufacturer's weight-based formula

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the sizes of the PLMA determined with the ear-based formula
Time Frame: One year
we were to determine whether the size of the auricle could be used as a proxy for the appropriate size of the PLMA
One year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yeditepe University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

September 22, 2014

First Submitted That Met QC Criteria

October 1, 2014

First Posted (Estimate)

October 6, 2014

Study Record Updates

Last Update Posted (Estimate)

October 6, 2014

Last Update Submitted That Met QC Criteria

October 1, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 346

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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