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

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

197 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2013-06-30

Brief Summary

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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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Detailed Description

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Conditions

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Ear Based ProSeal LMA

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Ear-sized based

Intervention Type 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

Interventions

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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

Intervention Type DEVICE

Eligibility Criteria

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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.

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No