Usefulness of Light Wand-guided Insertion of Flexible Reinforced Laryngeal Mask Airway

NCT ID: NCT03224611

Last Updated: 2018-10-17

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

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-01

Study Completion Date

2018-09-30

Brief Summary

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Flexible LMA (Laryngeal mask airway) is very useful for variable situation but it is hard to insert in correct position because of it's flexible structure. Especially in classical way of manual LMA insertion, when the index finger could not guide the flexible LMA to the optimal position, we could not guarantee the correct position of the LMA. Therefore several studies have been investigated to improve this.

The light wand is a kind of stylet which have a light on the tip. Recently some studies demonstrated the usefulness of the light wand which could be used for indicating correct position of the LMA. We hypothesised there will be two advantages if the light wand is used as a stylet of the flexible LMA. First the stylet could support the mildness of the flexible LMA, and second the lightness could confirm the correct position of the flexible LMA.

Detailed Description

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Conditions

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Laryngeal Mask Airway

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Control group

The flexible LMA is inserted using "index finger technique"

Group Type NO_INTERVENTION

No interventions assigned to this group

Light wand group

The flexible LMA is inserted using light wand as a stylet

Group Type ACTIVE_COMPARATOR

light wand

Intervention Type DEVICE

The light wand is used as a stylet of the flexible LMA. When the investigator inserts the flexible LMA in "light wand group", the correct position of the LMA is confirmed by the light.

Interventions

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light wand

The light wand is used as a stylet of the flexible LMA. When the investigator inserts the flexible LMA in "light wand group", the correct position of the LMA is confirmed by the light.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* The patient need general anesthesia using LMA and belonged to the ASA(American society of Anesthesiologist) class I or II

Exclusion Criteria

* The patient who has URI(upper respiratory infection) symptom within 14 days or
* The patient's BMI(body mass index) exceeds 35 kg/m2
* The patient has severe GERD(gastroesophageal reflux disease) or hiatus hernia
* The patient who has any contraindication for LMA insertion
Minimum Eligible Age

19 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ajou University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Jiyoung Yoo

clinical assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ji Young Yoo

Role: PRINCIPAL_INVESTIGATOR

Clinical assistant professor

Locations

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Ajou University Hospital

Suwon, Gyeonggido, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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AJIRB-MED-OBS-17-108

Identifier Type: -

Identifier Source: org_study_id

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