ClinicalTrials.gg
CompletedNCT03368911Updated Feb 28, 2019

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

An interventional study of Oral/Nasal Endotracheal Tube, Reinforced (Covidien) and TaperGuard oral tracheal tube (Covidien) in Voice Hoarseness, Sore Throat and Thyroidectomy, sponsored by Chonnam National University Hospital. Completed at 2 sites in Korea, Republic of. Open to participants aged 20 Years to 70 Years. Per ClinicalTrials.gov, last updated 2019-02-28.

Sponsored by Chonnam National University Hospital · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
140
Allocation
Randomized
Ages
20 Years to 70 Years
Sex
All
01

Study 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

02

Conditions studied

  • Voice Hoarseness
  • Sore Throat
  • Thyroidectomy

Keywords

  • Hoarseness
  • Sore Throat
  • Thyroidectomy
03

In context

Hoarseness

52 studies on the registry are indexed under Hoarseness; 9 are open to participants now.

This study's enrollment of 140 is above the median of 108 across 44 interventional studies indexed under Hoarseness.

Browse Hoarseness studies →

Lead sponsor

Chonnam National University Hospital is the lead sponsor of 72 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

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 ( > 30 kg/m2)
  • Recurrent laryngeal injury during operation
  • Operation history of oral and laryngeal surgery
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
140 participants (actual)

Study arms

  • Experimental
    Reinforced tube group

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

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

  • Active comparator
    Conventional tube group

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

    Device: TaperGuard oral tracheal tube (Covidien)

Interventions

  • DeviceOral/Nasal Endotracheal Tube, Reinforced (Covidien)

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

  • DeviceTaperGuard oral tracheal tube (Covidien)

    Use TaperGuard oral tracheal tube (Covidien) for endotracheal intubation

06

What researchers measure

Primary outcomes

  1. hoarseness

    compare the incidence and degree of the hoarseness after thyroidectomy

    Time frame: assess after 1hours after operation

  2. sore throat

    compare the incidence and degree of the sore throat after thyroidectomy

    Time frame: assess after 1hours after operation

  3. hoarseness

    compare the incidence and degree of the hoarseness after thyroidectomy

    Time frame: assess after 24 hours after operation

  4. sore throat

    compare the incidence and degree of the sore throat after thyroidectomy

    Time frame: assess after 24hours after operation

  5. hoarseness

    compare the incidence and degree of the hoarseness after thyroidectomy

    Time frame: assess after 48 hours after operation

  6. sore throat

    compare the incidence and degree of the sore throat after thyroidectomy

    Time frame: assess after 48 hours after operation

07

Study locations

2 sites
  • Chonnam National University Hwasun Hopspital
    Hwasun, Jeollanamdo 58128, Korea, Republic of
  • Chonnam National University Hospital
    Gwangju, 505-757, Korea, Republic of
08

References and documents

Individual participant data

Plan to share: Yes

Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 28, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03368911
Lead sponsor
Chonnam National University Hospital
Responsible party
Seongtae Jeong (Associate Professor, Chonnam National University Hospital) — Principal investigator
First posted
Dec 11, 2017
Start date
Dec 1, 2017
Primary completion
Nov 30, 2018
Completion
Nov 30, 2018
Last update
Feb 28, 2019

Study contacts

Seongtae Jeong
principal investigator · Chonnam National University Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion