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

Primary Purpose

Voice Hoarseness, Sore Throat, Thyroidectomy

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Oral/Nasal Endotracheal Tube, Reinforced (Covidien)
TaperGuard oral tracheal tube (Covidien)
Sponsored by
Chonnam National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Voice Hoarseness focused on measuring Hoarseness, Sore Throat, Thyroidectomy

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Chonnam National University Hwasun Hopspital
  • Chonnam National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Reinforced tube group

Conventional tube group

Arm Description

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

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

Outcomes

Primary Outcome Measures

hoarseness
compare the incidence and degree of the hoarseness after thyroidectomy
sore throat
compare the incidence and degree of the sore throat after thyroidectomy
hoarseness
compare the incidence and degree of the hoarseness after thyroidectomy
sore throat
compare the incidence and degree of the sore throat after thyroidectomy
hoarseness
compare the incidence and degree of the hoarseness after thyroidectomy
sore throat
compare the incidence and degree of the sore throat after thyroidectomy

Secondary Outcome Measures

Full Information

First Posted
November 30, 2017
Last Updated
February 26, 2019
Sponsor
Chonnam National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03368911
Brief Title
The Effect of Reinforced Endotracheal Tube on Post-operative Hoarseness Undergoing Thyroidectomy
Official Title
The Effect of Reinforced Endotracheal Tube on Post-operative Hoarseness
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
December 1, 2017 (Actual)
Primary Completion Date
November 30, 2018 (Actual)
Study Completion Date
November 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chonnam National University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Voice Hoarseness, Sore Throat, Thyroidectomy
Keywords
Hoarseness, Sore Throat, Thyroidectomy

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Primary outcome is assessed by other investigator who do not know which endotrachdeal tube is used.
Allocation
Randomized
Enrollment
140 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Reinforced tube group
Arm Type
Experimental
Arm Description
use an reinforced endotracheal tube for endotracheal intubation during general anesthesia undergoing thyroidectomy
Arm Title
Conventional tube group
Arm Type
Active Comparator
Arm Description
use an conventional endotracheal tube for endotracheal intubation during general anesthesia undergoing thyroidectomy
Intervention Type
Device
Intervention Name(s)
Oral/Nasal Endotracheal Tube, Reinforced (Covidien)
Intervention Description
Use Oral/Nasal Endotracheal Tube, Reinforced (Covidien) for endotracheal intubation
Intervention Type
Device
Intervention Name(s)
TaperGuard oral tracheal tube (Covidien)
Intervention Description
Use TaperGuard oral tracheal tube (Covidien) for endotracheal intubation
Primary Outcome Measure Information:
Title
hoarseness
Description
compare the incidence and degree of the hoarseness after thyroidectomy
Time Frame
assess after 1hours after operation
Title
sore throat
Description
compare the incidence and degree of the sore throat after thyroidectomy
Time Frame
assess after 1hours after operation
Title
hoarseness
Description
compare the incidence and degree of the hoarseness after thyroidectomy
Time Frame
assess after 24 hours after operation
Title
sore throat
Description
compare the incidence and degree of the sore throat after thyroidectomy
Time Frame
assess after 24hours after operation
Title
hoarseness
Description
compare the incidence and degree of the hoarseness after thyroidectomy
Time Frame
assess after 48 hours after operation
Title
sore throat
Description
compare the incidence and degree of the sore throat after thyroidectomy
Time Frame
assess after 48 hours after operation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seongtae Jeong
Organizational Affiliation
Chonnam National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chonnam National University Hwasun Hopspital
City
Hwasun
State/Province
Jeollanamdo
ZIP/Postal Code
58128
Country
Korea, Republic of
Facility Name
Chonnam National University Hospital
City
Gwangju
ZIP/Postal Code
505-757
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

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

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