Thyroid NoduleNCT02410928
Comparison of the Vocal Cord Imaging Techniques After Thyroidectomy
A study testing direct laringoscopy, fiberoptic nasal laringoscopy and ultrasonograph in people with Thyroid Nodule, run by Diskapi Teaching and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Recurrent nerve palsy is a complication of thyroidectomy. Most surgeons want to visualize the vocal cords after tyroidectomy. The aim is to compare the direct laringoscopy, videolaringoscopy, fiberoptic laringoscopy and ultrasonography methods in terms of efficacy, duration and hemodynamic responses during the… Read more about this study
- Who is it for?
- Ages 19 to 70 years
- Conditions the study is for
- Thyroid Nodule
- What is being tested?
- direct laringoscopy, fiberoptic nasal laringoscopy and ultrasonograph
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Apr 2015to Jul 2015
- 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 19 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Benign or malignant thyroid pathology
Who cannot join
- anticipated difficult intubation
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Diskapi Yildirim Beyazit Teaching and Research Hospital
Ankara, 06110
About this study
Recurrent nerve palsy is a complication of thyroidectomy. Most surgeons want to visualize the vocal cords after tyroidectomy. The aim is to compare the direct laringoscopy, videolaringoscopy, fiberoptic laringoscopy and ultrasonography methods in terms of efficacy, duration and hemodynamic responses during the procedure.
Read the detailed description
The vocal cord will be visualised after the extubation with one of the following methods:
direct laringoscopy videolaringoscopy fiberoptic laringoscopy ultrasonography The of efficacy of the method (0= not able to visualize the vocal cords, 1= the vocal cords were visualized) duration of the procedure and hemodynamic responses (heart rate, mean arterial pressure) during the procedure will be compared between the groups.
- Conditions
- Thyroid Nodule
- Being tested
- direct laringoscopy, fiberoptic nasal laringoscopy, ultrasonograph
- Medical subject headings
- Thyroid Nodule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
direct laringoscopyDevice
Also called direct laryngoscopy
the vocal cords will be visualized after extubation with direct laringoscopy
fiberoptic nasal laringoscopyDevice
Also called fiberoptic laryngoscopy
the vocal cords will be visualized after extubation with fiberoptic nasal laringoscopy
ultrasonographDevice
Also called ultrsonography
the vocal cords will be visualized after extubation with fiberoptic ultrasonography
| Study group | Role | What they receive |
|---|---|---|
| fiberoptic nasal laringoscopy | Experimental | the vocal cords ill be visualized with fiberoptic nasal laringoscopy Receives: Device: fiberoptic nasal laringoscopy |
| ultrasonography | Experimental | the vocal cords ill be visualized with ultrasonography Receives: Device: ultrasonograph |
| Direct laringoscopy | Active comparator | the vocal cords ill be visualized with direct laringoscopy Receives: Device: direct laringoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
visualisation of the vocal cords
the vocal cords will be examined after extubation
Measured: 1 min after extubation
duration of the procedure
the duration of the vocal cord examination
Measured: 10 min after extubation
mean arterial pressure
the mean arterial pressure will be measured after extubation
Measured: 10 min after extubation
heart rate
the heart rate will be measured after extubation
Measured: 10 min after extubation
peripheal oxygen saturation
the peripheal oxygen saturation will be measured after extubation
Measured: 10 min after extubation
Secondary outcomes (4)
hypertention
mean arterial pressure >20% from baseline value
Measured: 5 minutes after the extubation
tachycardia
heart rate >20% from baseline value
Measured: 5 minutes after the extubation
laceration
blood detected on the blade/fiber optic scope, or macroscopic blood on the oral nasal mucosa
Measured: 5 minutes after the extubation
teeht damage
broken teeht
Measured: 5 minutes after the extubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2015 (estimated)
- Study startApr 2015
- Primary completionJun 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Thyroid NoduleStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Diskapi Teaching and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, DILEK YAZICIOGLU, Diskapi Teaching and Research Hospital
- Investigators
- Dilek yazicioglu, Dr, Study director, Diskapi Teaching and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02410928
- Sponsor's protocol ID
- USG-Vokal cord
- Status last verified
- Feb 2015
- First submitted
- 14 Feb 2015
- Last updated
- 12 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Jeannon JP, Orabi AA, Bruch GA, Abdalsalam HA, Simo R. Diagnosis of recurrent laryngeal nerve palsy after thyroidectomy: a systematic review. Int J Clin Pract. 2009 Apr;63(4):624-9. doi: 10.1111/j.1742-1241.2008.01875.x.
PubMed 19335706Higgins TS, Gupta R, Ketcham AS, Sataloff RT, Wadsworth JT, Sinacori JT. Recurrent laryngeal nerve monitoring versus identification alone on post-thyroidectomy true vocal fold palsy: a meta-analysis. Laryngoscope. 2011 May;121(5):1009-17. doi: 10.1002/lary.21578.
PubMed 21520117Kristensen MS. Ultrasonography in the management of the airway. Acta Anaesthesiol Scand. 2011 Nov;55(10):1155-73. doi: 10.1111/j.1399-6576.2011.02518.x. Epub 2011 Sep 7.
PubMed 22092121
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Vocal Cord Imaging Techniques After Thyroidectomy
- ClinicalTrials.gov ID
- NCT02410928
- Acronym / sponsor ID
- USG-Vokal cord
- Conditions
- Thyroid Nodule
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Diskapi Teaching and Research HospitalUniversity, hospital or other
- Study start
- Apr 2015 (actual)
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 8 Apr 2015 (estimated)
- 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.
Recurrent nerve palsy is a complication of thyroidectomy. Most surgeons want to visualize the vocal cords after tyroidectomy. The aim is to compare the direct laringoscopy, videolaringoscopy, fiberoptic laringoscopy and ultrasonography methods in terms of efficacy, duration and hemodynamic responses during the procedure.
Detailed description
The vocal cord will be visualised after the extubation with one of the following methods:
direct laringoscopy videolaringoscopy fiberoptic laringoscopy ultrasonography The of efficacy of the method (0= not able to visualize the vocal cords, 1= the vocal cords were visualized) duration of the procedure and hemodynamic responses (heart rate, mean arterial pressure) during the procedure will be compared between the groups.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| fiberoptic nasal laringoscopy | Experimental | Device: fiberoptic nasal laringoscopythe vocal cords ill be visualized with fiberoptic nasal laringoscopy |
| ultrasonography | Experimental | Device: ultrasonographthe vocal cords ill be visualized with ultrasonography |
| Direct laringoscopy | Active comparator | Device: direct laringoscopythe vocal cords ill be visualized with direct laringoscopy |
Who may qualify
- Ages
- 19 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Benign or malignant thyroid pathology
Key exclusion criteria (1 listed)
- anticipated difficult intubation
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 |
|---|---|---|
| direct laringoscopyAlso: direct laryngoscopythe vocal cords will be visualized after extubation with direct laringoscopy | Device | Direct laringoscopy |
| fiberoptic nasal laringoscopyAlso: fiberoptic laryngoscopythe vocal cords will be visualized after extubation with fiberoptic nasal laringoscopy | Device | fiberoptic nasal laringoscopy |
| ultrasonographAlso: ultrsonographythe vocal cords will be visualized after extubation with fiberoptic ultrasonography | Device | ultrasonography |
Primary outcome
visualisation of the vocal cords
Time frame: 1 min after extubation
the vocal cords will be examined after extubation
duration of the procedure
Time frame: 10 min after extubation
the duration of the vocal cord examination
mean arterial pressure
Time frame: 10 min after extubation
the mean arterial pressure will be measured after extubation
heart rate
Time frame: 10 min after extubation
the heart rate will be measured after extubation
peripheal oxygen saturation
Time frame: 10 min after extubation
the peripheal oxygen saturation will be measured after extubation
4 secondary outcomes
hypertention
Time frame: 5 minutes after the extubation
tachycardia
Time frame: 5 minutes after the extubation
laceration
Time frame: 5 minutes after the extubation
teeht damage
Time frame: 5 minutes after the extubation
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 12 Sep 2017.
- Background: PubMed 19335706Jeannon JP, Orabi AA, Bruch GA, Abdalsalam HA, Simo R. Diagnosis of recurrent laryngeal nerve palsy after thyroidectomy: a systematic review. Int J Clin Pract. 2009 Apr;63(4):624-9. doi: 10.1111/j.1742-1241.2008.01875.x.
- Results publication: PubMed 21520117Higgins TS, Gupta R, Ketcham AS, Sataloff RT, Wadsworth JT, Sinacori JT. Recurrent laryngeal nerve monitoring versus identification alone on post-thyroidectomy true vocal fold palsy: a meta-analysis. Laryngoscope. 2011 May;121(5):1009-17. doi: 10.1002/lary.21578.
- Results publication: PubMed 22092121Kristensen MS. Ultrasonography in the management of the airway. Acta Anaesthesiol Scand. 2011 Nov;55(10):1155-73. doi: 10.1111/j.1399-6576.2011.02518.x. Epub 2011 Sep 7.
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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.
Dilek yazicioglu, Dr study director
Diskapi Teaching and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing direct laringoscopy, fiberoptic nasal laringoscopy and ultrasonograph in people with Thyroid Nodule, run by Diskapi Teaching and Research Hospital at 1 site in Turkey (Türkiye).
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 1 inclusion and 1 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 12 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). 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?
visualisation of the vocal cords (time frame: 1 min after extubation). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02410928, which also lists 3 linked publications.
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 12 Sep 2017.