Thyroid Nodule Clinical Trial
Official title:
Comparison of the Vocal Cord Imaging Techniques After Thyroidectomy
Verified date | February 2015 |
Source | Diskapi Teaching and Research Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Turkey | Diskapi Yildirim Beyazit Teaching and Research Hospital | Ankara |
Lead Sponsor | Collaborator |
---|---|
Diskapi Teaching and Research Hospital |
Turkey,
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
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 |
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