Flexible Laryngeal Mask Airway Versus Tracheal Intubation in Nasal Bone Fracture

NCT ID: NCT04520555

Last Updated: 2022-07-20

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

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-13

Study Completion Date

2022-01-27

Brief Summary

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In surgery under general anesthesia due to nasal bone fracture, laryngeal mask airway or tracheal intubation has been used. However, it has not been investigated that the difference of recovery profiles according to use of laryngeal mask airway or tracheal intubation in nasal bone fracture surgery. The aim of study is to evaluate the efficacy of the laryngeal mask airway regarding recovery profiles and airway complications, compared to tracheal intubation.

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

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Laryngeal mask airway group

Flexible laryngeal mask airway is inserted for general anesthesia

Group Type EXPERIMENTAL

Laryngeal mask airway

Intervention Type DEVICE

LMA Flexible is a supraglottic airway device, which can be moved out of the surgical field without displacement of the cuff, or loss of seal for the anesthetist

intubation group

Endotracheal intubation was performed for general anesthesia

Group Type ACTIVE_COMPARATOR

Endotracheal tube

Intervention Type DEVICE

Endotracheal tube is a plain tube, which is most commonly used in general anesthesia.

Interventions

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Laryngeal mask airway

LMA Flexible is a supraglottic airway device, which can be moved out of the surgical field without displacement of the cuff, or loss of seal for the anesthetist

Intervention Type DEVICE

Endotracheal tube

Endotracheal tube is a plain tube, which is most commonly used in general anesthesia.

Intervention Type DEVICE

Other Intervention Names

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LMA Flexible,Teleflex Co., Westmeath, Ireland Portex, Smiths Medical International Ltd., South East England, United Kingdom

Eligibility Criteria

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Inclusion Criteria

* Patients with American Society of Anesthesiologists classification 1 or 2 who receive general anesthesia due to nasal bone fracture

Exclusion Criteria

* Patients with high risk of aspiration, patients who anticipated difficult airway
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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Jong Yeop Kim

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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JongYeop Kim, M.D.,Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Ajou University School of Medicine

Locations

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Ajou University Hospital

Suwon, Gyeongki-do, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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AJIRB-MED-OBS-20-081

Identifier Type: -

Identifier Source: org_study_id

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