Voice HoarsenessNCT03368911
The Effect of Reinforced Endotracheal Tube on Post-operative Hoarseness Undergoing Thyroidectomy
A study testing Oral/Nasal Endotracheal Tube, Reinforced (Covidien) and TaperGuard oral tracheal tube (Covidien) in people with Voice Hoarseness and Sore Throat, run by Chonnam National University Hospital at 2 sites in South Korea.
Trial 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 Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Voice Hoarseness, Sore Throat, Thyroidectomy
- What is being tested?
- Oral/Nasal Endotracheal Tube, Reinforced (Covidien) and TaperGuard oral tracheal tube (Covidien)
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 1 Dec 2017to 30 Nov 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
Chonnam National University Hospital
Gwangju, 505-757
Chonnam National University Hwasun Hopspital
Hwasun, Jeollanamdo, 58128
About this study
Official title: The Effect of Reinforced Endotracheal Tube on Post-operative Hoarseness
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
- Conditions
- Voice Hoarseness, Sore Throat, Thyroidectomy
- Being tested
- Oral/Nasal Endotracheal Tube, Reinforced (Covidien), TaperGuard oral tracheal tube (Covidien)
- Keywords
- Hoarseness, Sore Throat, Thyroidectomy
- Medical subject headings
- Hoarseness, Pharyngitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral/Nasal Endotracheal Tube, Reinforced (Covidien)Device
Use Oral/Nasal Endotracheal Tube, Reinforced (Covidien) for endotracheal intubation
TaperGuard oral tracheal tube (Covidien)Device
Use TaperGuard oral tracheal tube (Covidien) for endotracheal intubation
| Study group | Role | What they receive |
|---|---|---|
| Reinforced tube group | Experimental | use an reinforced endotracheal tube for endotracheal intubation during general anesthesia undergoing thyroidectomy Receives: 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 Receives: Device: TaperGuard oral tracheal tube (Covidien) |
What is being measured
The primary outcome is the main question the study is designed to answer.
hoarseness
compare the incidence and degree of the hoarseness after thyroidectomy
Measured: assess after 1hours after operation
sore throat
compare the incidence and degree of the sore throat after thyroidectomy
Measured: assess after 1hours after operation
hoarseness
compare the incidence and degree of the hoarseness after thyroidectomy
Measured: assess after 24 hours after operation
sore throat
compare the incidence and degree of the sore throat after thyroidectomy
Measured: assess after 24hours after operation
hoarseness
compare the incidence and degree of the hoarseness after thyroidectomy
Measured: assess after 48 hours after operation
sore throat
compare the incidence and degree of the sore throat after thyroidectomy
Measured: assess after 48 hours after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2017
- Study start1 Dec 2017
- Primary completion30 Nov 2018
- Study completion30 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Voice HoarsenessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chonnam National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seongtae Jeong, Chonnam National University Hospital
- Investigators
- Seongtae Jeong, Principal investigator, Chonnam National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03368911
- Sponsor's protocol ID
- CNUHH-2017-102
- Status last verified
- Feb 2019
- First submitted
- 30 Nov 2017
- Last updated
- 28 Feb 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Reinforced Endotracheal Tube on Post-operative Hoarseness
- ClinicalTrials.gov ID
- NCT03368911
- Acronym / sponsor ID
- CNUHH-2017-102
- Conditions
- Voice Hoarseness, Sore Throat, Thyroidectomy
- Keywords
- Hoarseness, Sore Throat, Thyroidectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Chonnam National University HospitalUniversity, hospital or other
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 30 Nov 2018 (actual)
- Study completion
- 30 Nov 2018 (actual)
- First posted
- 11 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reinforced tube group | Experimental | Device: Oral/Nasal Endotracheal Tube, Reinforced (Covidien)use an reinforced endotracheal tube for endotracheal intubation during general anesthesia undergoing thyroidectomy |
| Conventional tube group | Active comparator | Device: TaperGuard oral tracheal tube (Covidien)use an conventional endotracheal tube for endotracheal intubation during general anesthesia undergoing thyroidectomy |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral/Nasal Endotracheal Tube, Reinforced (Covidien)Use Oral/Nasal Endotracheal Tube, Reinforced (Covidien) for endotracheal intubation | Device | Reinforced tube group |
| TaperGuard oral tracheal tube (Covidien)Use TaperGuard oral tracheal tube (Covidien) for endotracheal intubation | Device | Conventional tube group |
Primary outcome
hoarseness
Time frame: assess after 1hours after operation
compare the incidence and degree of the hoarseness after thyroidectomy
sore throat
Time frame: assess after 1hours after operation
compare the incidence and degree of the sore throat after thyroidectomy
hoarseness
Time frame: assess after 24 hours after operation
compare the incidence and degree of the hoarseness after thyroidectomy
sore throat
Time frame: assess after 24hours after operation
compare the incidence and degree of the sore throat after thyroidectomy
hoarseness
Time frame: assess after 48 hours after operation
compare the incidence and degree of the hoarseness after thyroidectomy
sore throat
Time frame: assess after 48 hours after operation
compare the incidence and degree of the sore throat after thyroidectomy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2019.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Seongtae Jeong principal investigator
Chonnam National University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral/Nasal Endotracheal Tube, Reinforced (Covidien) and TaperGuard oral tracheal tube (Covidien) in people with Voice Hoarseness and Sore Throat, run by Chonnam National University Hospital at 2 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
hoarseness (time frame: assess after 1hours after operation). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2019.