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Comparison of the Vocal Cord Imaging Techniques After Thyroidectomy

Primary Purpose

Thyroid Nodule

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
direct laringoscopy
fiberoptic nasal laringoscopy
ultrasonograph
Sponsored by
Diskapi Teaching and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Thyroid Nodule

Eligibility Criteria

19 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Benign or malignant thyroid pathology

Exclusion Criteria:

  • anticipated difficult intubation

Sites / Locations

  • Diskapi Yildirim Beyazit Teaching and Research Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

fiberoptic nasal laringoscopy

ultrasonography

Direct laringoscopy

Arm Description

the vocal cords ill be visualized with fiberoptic nasal laringoscopy

the vocal cords ill be visualized with ultrasonography

the vocal cords ill be visualized with direct laringoscopy

Outcomes

Primary Outcome Measures

visualisation of the vocal cords
the vocal cords will be examined after extubation
duration of the procedure
the duration of the vocal cord examination
mean arterial pressure
the mean arterial pressure will be measured after extubation
heart rate
the heart rate will be measured after extubation
peripheal oxygen saturation
the peripheal oxygen saturation will be measured after extubation

Secondary Outcome Measures

hypertention
mean arterial pressure >20% from baseline value
tachycardia
heart rate >20% from baseline value
laceration
blood detected on the blade/fiber optic scope, or macroscopic blood on the oral nasal mucosa
teeht damage
broken teeht

Full Information

First Posted
February 14, 2015
Last Updated
September 10, 2017
Sponsor
Diskapi Teaching and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02410928
Brief Title
Comparison of the Vocal Cord Imaging Techniques After Thyroidectomy
Official Title
Comparison of the Vocal Cord Imaging Techniques After Thyroidectomy
Study Type
Interventional

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
April 2015 (Actual)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
July 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Diskapi Teaching and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid Nodule

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Arm Title
fiberoptic nasal laringoscopy
Arm Type
Experimental
Arm Description
the vocal cords ill be visualized with fiberoptic nasal laringoscopy
Arm Title
ultrasonography
Arm Type
Experimental
Arm Description
the vocal cords ill be visualized with ultrasonography
Arm Title
Direct laringoscopy
Arm Type
Active Comparator
Arm Description
the vocal cords ill be visualized with direct laringoscopy
Intervention Type
Device
Intervention Name(s)
direct laringoscopy
Other Intervention Name(s)
direct laryngoscopy
Intervention Description
the vocal cords will be visualized after extubation with direct laringoscopy
Intervention Type
Device
Intervention Name(s)
fiberoptic nasal laringoscopy
Other Intervention Name(s)
fiberoptic laryngoscopy
Intervention Description
the vocal cords will be visualized after extubation with fiberoptic nasal laringoscopy
Intervention Type
Device
Intervention Name(s)
ultrasonograph
Other Intervention Name(s)
ultrsonography
Intervention Description
the vocal cords will be visualized after extubation with fiberoptic ultrasonography
Primary Outcome Measure Information:
Title
visualisation of the vocal cords
Description
the vocal cords will be examined after extubation
Time Frame
1 min after extubation
Title
duration of the procedure
Description
the duration of the vocal cord examination
Time Frame
10 min after extubation
Title
mean arterial pressure
Description
the mean arterial pressure will be measured after extubation
Time Frame
10 min after extubation
Title
heart rate
Description
the heart rate will be measured after extubation
Time Frame
10 min after extubation
Title
peripheal oxygen saturation
Description
the peripheal oxygen saturation will be measured after extubation
Time Frame
10 min after extubation
Secondary Outcome Measure Information:
Title
hypertention
Description
mean arterial pressure >20% from baseline value
Time Frame
5 minutes after the extubation
Title
tachycardia
Description
heart rate >20% from baseline value
Time Frame
5 minutes after the extubation
Title
laceration
Description
blood detected on the blade/fiber optic scope, or macroscopic blood on the oral nasal mucosa
Time Frame
5 minutes after the extubation
Title
teeht damage
Description
broken teeht
Time Frame
5 minutes after the extubation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Benign or malignant thyroid pathology Exclusion Criteria: anticipated difficult intubation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dilek yazicioglu, Dr
Organizational Affiliation
Diskapi Teaching and Research Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Diskapi Yildirim Beyazit Teaching and Research Hospital
City
Ankara
ZIP/Postal Code
06110
Country
Turkey

12. IPD Sharing Statement

Citations:
PubMed Identifier
19335706
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.
Results Reference
background
PubMed Identifier
21520117
Citation
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.
Results Reference
result
PubMed Identifier
22092121
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.
Results Reference
result

Learn more about this trial

Comparison of the Vocal Cord Imaging Techniques After Thyroidectomy

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