Videoscope Guided Flexible LMA Insertion

NCT ID: NCT03510299

Last Updated: 2018-05-01

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

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-20

Study Completion Date

2017-12-31

Brief Summary

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Laryngeal Mask Airway Flexible (LMA Flexible) is useful in various surgery because of its unique design. The flexometallic tube allows it could be used in head and neck related surgery but also make insertion more difficult. The ideal position of LMA Flexible is important because in most case, the surgery requiring LMA Flexible allows movements of the stem or patient's head during operation without dislodgement of LMA Flexible. Several studies have examined different techniques like assisting LMA Flexible with rigid introducers or lifting epiglottis with direct laryngoscope. But there is no study using videolaryngoscope (VL) for LMA Flexible insertion. The investigator hypothesized that McGrath(McGRATH™ MAC video laryngoscope;Aircraft Medical Ltd, UK.), one kind of the VL, assisted insertion would increase the success rate of LMA Flexible insertion by lifting epiglottis and securing a view while LMA Flexible is seated. The aim of this study was to investigate the efficacy of the McGrath VL assisted insertion of LMA Flexible compared with the standard method of digital manipulation technique in regard to the ideal anatomical position and sealing pressure in anesthetized adult patients.

Detailed Description

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Conditions

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Ideal Position of LMA Flexible

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Control group

Group Type PLACEBO_COMPARATOR

Control

Intervention Type DEVICE

Digital manipulation technique of LMA flexible insertion

McGrath group

Group Type EXPERIMENTAL

Mcgrath

Intervention Type DEVICE

McGrath assisted insertion of LMA flexible

Interventions

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Mcgrath

McGrath assisted insertion of LMA flexible

Intervention Type DEVICE

Control

Digital manipulation technique of LMA flexible insertion

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* ASA (American society of anesthesiologist) physical status classification system I and II,
* scheduled to elective general anesthesia with the use of LMA

Exclusion Criteria

* suspected difficult airway
* a history of a recent upper airway tract infection
* gastroesophageal reflux
* body mass index \> 30 kg/m2
Minimum Eligible Age

19 Years

Maximum Eligible Age

70 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

Assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Jiyoung Yoo

Suweon, Kyunggido, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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AJIRB-DEV-OBS-16-444

Identifier Type: -

Identifier Source: org_study_id

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