The Effect of Reinforced Endotracheal Tube on Post-operative Hoarseness Undergoing Thyroidectomy

NCT ID: NCT03368911

Last Updated: 2019-02-28

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

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-01

Study Completion Date

2018-11-30

Brief Summary

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The purpose of this study is an evaluation of the effect of the reinforced endotracheal tube on post-operative hoarseness and sore throat undergoing thyroidectomy

Detailed Description

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Conditions

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Voice Hoarseness Sore Throat Thyroidectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors
Primary outcome is assessed by other investigator who do not know which endotrachdeal tube is used.

Study Groups

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Reinforced tube group

use an reinforced endotracheal tube for endotracheal intubation during general anesthesia undergoing thyroidectomy

Group Type EXPERIMENTAL

Oral/Nasal Endotracheal Tube, Reinforced (Covidien)

Intervention Type DEVICE

Use Oral/Nasal Endotracheal Tube, Reinforced (Covidien) for endotracheal intubation

Conventional tube group

use an conventional endotracheal tube for endotracheal intubation during general anesthesia undergoing thyroidectomy

Group Type ACTIVE_COMPARATOR

TaperGuard oral tracheal tube (Covidien)

Intervention Type DEVICE

Use TaperGuard oral tracheal tube (Covidien) for endotracheal intubation

Interventions

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Oral/Nasal Endotracheal Tube, Reinforced (Covidien)

Use Oral/Nasal Endotracheal Tube, Reinforced (Covidien) for endotracheal intubation

Intervention Type DEVICE

TaperGuard oral tracheal tube (Covidien)

Use TaperGuard oral tracheal tube (Covidien) for endotracheal intubation

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* American Society of Anesthesiologist physical status 1-3
* Patients undergoing thyroidectomy under general anesthesia
* Tumor size \< 2cm
* Patient who do not have any problem in the vocal cord

Exclusion Criteria

* Patient who is expected difficult intubation (Mallampati class 3 or more)
* Patient who has respiratory disorder
* Previous hoarseness and sore throat history
* Obesity (BMI \> 30 kg/m2)
* Recurrent laryngeal injury during operation
* Operation history of oral and laryngeal surgery
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chonnam National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Seongtae Jeong

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Seongtae Jeong

Role: PRINCIPAL_INVESTIGATOR

Chonnam National University Hospital

Locations

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Chonnam National University Hwasun Hopspital

Hwasun, Jeollanamdo, South Korea

Site Status

Chonnam National University Hospital

Gwangju, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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CNUHH-2017-102

Identifier Type: -

Identifier Source: org_study_id

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