Comparison of the Vocal Cord Imaging Techniques After Thyroidectomy

NCT ID: NCT02410928

Last Updated: 2017-09-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2015-07-31

Brief Summary

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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

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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

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Thyroid Nodule

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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fiberoptic nasal laringoscopy

the vocal cords ill be visualized with fiberoptic nasal laringoscopy

Group Type EXPERIMENTAL

fiberoptic nasal laringoscopy

Intervention Type DEVICE

the vocal cords will be visualized after extubation with fiberoptic nasal laringoscopy

ultrasonography

the vocal cords ill be visualized with ultrasonography

Group Type EXPERIMENTAL

ultrasonograph

Intervention Type DEVICE

the vocal cords will be visualized after extubation with fiberoptic ultrasonography

Direct laringoscopy

the vocal cords ill be visualized with direct laringoscopy

Group Type ACTIVE_COMPARATOR

direct laringoscopy

Intervention Type DEVICE

the vocal cords will be visualized after extubation with direct laringoscopy

Interventions

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direct laringoscopy

the vocal cords will be visualized after extubation with direct laringoscopy

Intervention Type DEVICE

fiberoptic nasal laringoscopy

the vocal cords will be visualized after extubation with fiberoptic nasal laringoscopy

Intervention Type DEVICE

ultrasonograph

the vocal cords will be visualized after extubation with fiberoptic ultrasonography

Intervention Type DEVICE

Other Intervention Names

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direct laryngoscopy fiberoptic laryngoscopy ultrsonography

Eligibility Criteria

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Inclusion Criteria

* Benign or malignant thyroid pathology

Exclusion Criteria

* anticipated difficult intubation
Minimum Eligible Age

19 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Diskapi Teaching and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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DILEK YAZICIOGLU

DR

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dilek yazicioglu, Dr

Role: STUDY_DIRECTOR

Diskapi Teaching and Research Hospital

Locations

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Diskapi Yildirim Beyazit Teaching and Research Hospital

Ankara, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 19335706 (View on PubMed)

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.

Reference Type RESULT
PMID: 21520117 (View on PubMed)

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.

Reference Type RESULT
PMID: 22092121 (View on PubMed)

Other Identifiers

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USG-Vokal cord

Identifier Type: -

Identifier Source: org_study_id

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