NCT03368911

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2017

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 30, 2017

Completed
1 day until next milestone

Study Start

First participant enrolled

December 1, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 11, 2017

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2018

Completed
Last Updated

February 28, 2019

Status Verified

February 1, 2019

Enrollment Period

12 months

First QC Date

November 30, 2017

Last Update Submit

February 26, 2019

Conditions

Voice HoarsenessSore ThroatThyroidectomy

Keywords

HoarsenessSore ThroatThyroidectomy

Outcome Measures

Primary Outcomes (6)

  • hoarseness

    compare the incidence and degree of the hoarseness after thyroidectomy

    assess after 1hours after operation

  • sore throat

    compare the incidence and degree of the sore throat after thyroidectomy

    assess after 1hours after operation

  • hoarseness

    compare the incidence and degree of the hoarseness after thyroidectomy

    assess after 24 hours after operation

  • sore throat

    compare the incidence and degree of the sore throat after thyroidectomy

    assess after 24hours after operation

  • hoarseness

    compare the incidence and degree of the hoarseness after thyroidectomy

    assess after 48 hours after operation

  • sore throat

    compare the incidence and degree of the sore throat after thyroidectomy

    assess after 48 hours after operation

Study Arms (2)

Reinforced tube group

EXPERIMENTAL

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

Device: Oral/Nasal Endotracheal Tube, Reinforced (Covidien)

Conventional tube group

ACTIVE COMPARATOR

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

Device: TaperGuard oral tracheal tube (Covidien)

Interventions

Oral/Nasal Endotracheal Tube, Reinforced (Covidien)DEVICE

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

Reinforced tube group
TaperGuard oral tracheal tube (Covidien)DEVICE

Use TaperGuard oral tracheal tube (Covidien) for endotracheal intubation

Conventional tube group

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Chonnam National University Hwasun Hopspital

Hwasun, Jeollanamdo, 58128, South Korea

Location

Chonnam National University Hospital

Gwangju, 505-757, South Korea

Location

MeSH Terms

Conditions

HoarsenessPharyngitis

Condition Hierarchy (Ancestors)

Voice DisordersLaryngeal DiseasesRespiratory Tract DiseasesRespiration DisordersOtorhinolaryngologic DiseasesNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsSigns and Symptoms, RespiratoryRespiratory Tract InfectionsInfectionsPharyngeal DiseasesStomatognathic Diseases

Study Officials

  • Seongtae Jeong

    Chonnam National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Primary outcome is assessed by other investigator who do not know which endotrachdeal tube is used.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

November 30, 2017

First Posted

December 11, 2017

Study Start

December 1, 2017

Primary Completion

November 30, 2018

Study Completion

November 30, 2018

Last Updated

February 28, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR

Locations

KR(2)