Comparison of the Vocal Cord Imaging Techniques After Thyroidectomy

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.

Study Overview

• Status: Completed
• Conditions: Thyroid Nodule
• Intervention / Treatment: Device: fiberoptic nasal laringoscopy; Device: ultrasonograph; Device: direct laringoscopy

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 Type: Interventional
• Enrollment (Actual): 75
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey, 06110
    • Diskapi Yildirim Beyazit Teaching and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Benign or malignant thyroid pathology

Exclusion Criteria:

• anticipated difficult intubation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: fiberoptic nasal laringoscopy; the vocal cords ill be visualized with fiberoptic nasal laringoscopy	Device: fiberoptic nasal laringoscopy; the vocal cords will be visualized after extubation with fiberoptic nasal laringoscopy; Other Names: fiberoptic laryngoscopy
Experimental: ultrasonography; the vocal cords ill be visualized with ultrasonography	Device: ultrasonograph; the vocal cords will be visualized after extubation with fiberoptic ultrasonography; Other Names: ultrsonography
Active Comparator: Direct laringoscopy; the vocal cords ill be visualized with direct laringoscopy	Device: direct laringoscopy; the vocal cords will be visualized after extubation with direct laringoscopy; Other Names: direct laryngoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
visualisation of the vocal cords	the vocal cords will be examined after extubation	1 min after extubation
duration of the procedure	the duration of the vocal cord examination	10 min after extubation
mean arterial pressure	the mean arterial pressure will be measured after extubation	10 min after extubation
heart rate	the heart rate will be measured after extubation	10 min after extubation
peripheal oxygen saturation	the peripheal oxygen saturation will be measured after extubation	10 min after extubation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
hypertention	mean arterial pressure >20% from baseline value	5 minutes after the extubation
tachycardia	heart rate >20% from baseline value	5 minutes after the extubation
laceration	blood detected on the blade/fiber optic scope, or macroscopic blood on the oral nasal mucosa	5 minutes after the extubation
teeht damage	broken teeht	5 minutes after the extubation

Collaborators and Investigators

• Sponsor: Diskapi Teaching and Research Hospital
• Investigators: Study Director: Dilek yazicioglu, Dr, Diskapi Teaching and Research Hospital

Publications and helpful links

General 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.
• 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/lary.21578.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2015
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): July 1, 2015

Study Registration Dates

• First Submitted: February 14, 2015
• First Submitted That Met QC Criteria: April 2, 2015
• First Posted (Estimate): April 8, 2015

Study Record Updates

• Last Update Posted (Actual): September 12, 2017
• Last Update Submitted That Met QC Criteria: September 10, 2017
• Last Verified: February 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Endocrine System Diseases; Endocrine Gland Neoplasms; Thyroid Diseases; Head and Neck Neoplasms; Thyroid Neoplasms; Thyroid Nodule
• Other Study ID Numbers: USG-Vokal cord

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No