Clinical Trials Logo
  1. Home
  2. Thyroid Nodule
  3. NCT02410928
  4. Details
NCT02410928 Clinical Trial

Comparison of the Vocal Cord Imaging Techniques After Thyroidectomy

Thyroid Nodule Clinical Trial

Official title:
Comparison of the Vocal Cord Imaging Techniques After Thyroidectomy

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02410928
Other study ID # USG-Vokal cord
Secondary ID
Status Completed
Phase N/A
First received February 14, 2015
Last updated September 10, 2017
Start date April 2015
Est. completion date July 2015

Study information
Verified date February 2015
Source Diskapi Teaching and Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 procedure.

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.

Recruitment information / eligibility
Status Completed
Enrollment 75
Est. completion date July 2015
Est. primary completion date June 2015
Accepts healthy volunteers No
Gender All
Age group 19 Years to 70 Years
Eligibility Inclusion Criteria:

- Benign or malignant thyroid pathology

Exclusion Criteria:

- anticipated difficult intubation

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• direct laringoscopy
the vocal cords will be visualized after extubation with direct laringoscopy
• fiberoptic nasal laringoscopy
the vocal cords will be visualized after extubation with fiberoptic nasal laringoscopy
• ultrasonograph
the vocal cords will be visualized after extubation with fiberoptic ultrasonography

Locations
Country Name City State
Turkey Diskapi Yildirim Beyazit Teaching and Research Hospital Ankara

Sponsors (1)
Lead Sponsor Collaborator
Diskapi Teaching and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

Higgins 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/lar — View Citation

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. Review. — View Citation

Kristensen 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. Review. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary visualisation of the vocal cords the vocal cords will be examined after extubation 1 min after extubation
Primary duration of the procedure the duration of the vocal cord examination 10 min after extubation
Primary mean arterial pressure the mean arterial pressure will be measured after extubation 10 min after extubation
Primary heart rate the heart rate will be measured after extubation 10 min after extubation
Primary peripheal oxygen saturation the peripheal oxygen saturation will be measured after extubation 10 min after extubation
Secondary hypertention mean arterial pressure >20% from baseline value 5 minutes after the extubation
Secondary tachycardia heart rate >20% from baseline value 5 minutes after the extubation
Secondary laceration blood detected on the blade/fiber optic scope, or macroscopic blood on the oral nasal mucosa 5 minutes after the extubation
Secondary teeht damage broken teeht 5 minutes after the extubation
See also
  Status Clinical Trial Phase
Terminated NCT04614389 - Utility of Contrast-Enhanced Sonography and Shear Wave Elastography N/A
Recruiting NCT03295955 - Comparing Efficacy of Postoperative Oral Antibiotic Use in Trans-Oral Thyroidectomy N/A
Completed NCT04647006 - Comparison of TOETVA and Conventional Thyroidectomy N/A
Not yet recruiting NCT06029946 - B-mode Ultrasound, Sono-Elastography, and Diffusion-weighted Imaging MRI in Thyroid Nodules
Recruiting NCT05025046 - NGS-based Thyroscan Genomic Classifier in the Diagnosis of Thyroid Nodules
Terminated NCT01320813 - Trial Comparing Complication Rates Associated With Robot-assisted Thyroidectomy to External Thyroidectomy N/A
Completed NCT00877630 - Minimal Invasiveness of Endoscopic Thyroidectomy N/A
Completed NCT01964508 - microRNA in Thyroid Cancer
Completed NCT06306599 - Ultrasound Operator Influence on Diagnostics With AI for Thyroid Nodules - Clinial Trial N/A
Recruiting NCT04730726 - In Vivo Multispectral Optoacoustic Imaging of Thyroid Nodules N/A
Not yet recruiting NCT03884140 - Clinical Diagnostic Approach for Cases of Thyroid Nodules
Completed NCT04277455 - Effect of Ultrasound Guided Laser Ablation Therapy on Symptomatic Benign Thyroid Nodules N/A
Recruiting NCT02225509 - Clinical Validation of a Molecular Signature to Detect Cancer in Thyroid Nodules With Indeterminate Cytology N/A
Completed NCT00552253 - Levothyroxine Treatment in Thyroid Benign Nodular Goiter N/A
Not yet recruiting NCT03700762 - Application of Ultrasonic Gray-scale Ratio in Differentiating Benign From Malignant Thyroid Nodules.
Enrolling by invitation NCT01757834 - Shear Wave Ultrasound Elastography in Noninvasive Diagnosis of Thyroid Nodules N/A
Completed NCT01292044 - The Role of Elastography in the Diagnosis of Thyroid Nodules N/A
Completed NCT00858104 - Percutaneous Laser Ablation in Benign Thyroid Nodules.Long Term Results Phase 4
Completed NCT00651625 - Reciprocating Medical Devices - a Study of a New Safety Device N/A
Completed NCT05132478 - The Effect of Surgeon Emotional Support on Treatment Choice for Low-risk Thyroid Cancer N/A