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OpenTrials
Completed

NCT Number: NCT02257411

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

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.

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Key information

Conditions

Ear Based ProSeal LMA

Age range

Up to 15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yeditepe University Hospital

Istanbul, Kozyatağı, 34752, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ear-sized based

Device

the sizes of the PLMA determined with the ear-based formula were compared with the sizes according to the manufacturer's weight-based formula

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Yeditepe University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Oct 6, 2014
Registry last updated
Oct 6, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.