NCT02410928

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 14, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 8, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

September 12, 2017

Status Verified

February 1, 2015

Enrollment Period

2 months

First QC Date

February 14, 2015

Last Update Submit

September 10, 2017

Conditions

Thyroid Nodule

Outcome Measures

Primary Outcomes (5)

  • 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 Outcomes (4)

  • hypertention

    5 minutes after the extubation

  • tachycardia

    5 minutes after the extubation

  • laceration

    5 minutes after the extubation

  • teeht damage

    5 minutes after the extubation

Study Arms (3)

fiberoptic nasal laringoscopy

EXPERIMENTAL

the vocal cords ill be visualized with fiberoptic nasal laringoscopy

Device: fiberoptic nasal laringoscopy

ultrasonography

EXPERIMENTAL

the vocal cords ill be visualized with ultrasonography

Device: ultrasonograph

Direct laringoscopy

ACTIVE COMPARATOR

the vocal cords ill be visualized with direct laringoscopy

Device: direct laringoscopy

Interventions

direct laringoscopyDEVICE

the vocal cords will be visualized after extubation with direct laringoscopy

Also known as: direct laryngoscopy
Direct laringoscopy
fiberoptic nasal laringoscopyDEVICE

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

Also known as: fiberoptic laryngoscopy
fiberoptic nasal laringoscopy
ultrasonographDEVICE

the vocal cords will be visualized after extubation with fiberoptic ultrasonography

Also known as: ultrsonography
ultrasonography

Eligibility Criteria

Age19 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Benign or malignant thyroid pathology

You may not qualify if:

  • anticipated difficult intubation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Diskapi Yildirim Beyazit Teaching and Research Hospital

Ankara, 06110, Turkey (Türkiye)

Location

Related Publications (3)

  • 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.

    PMID: 19335706BACKGROUND

  • 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.

    PMID: 21520117RESULT

  • 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.

    PMID: 22092121RESULT

MeSH Terms

Conditions

Thyroid Nodule

Condition Hierarchy (Ancestors)

Thyroid NeoplasmsEndocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsEndocrine System DiseasesThyroid Diseases

Study Officials

  • Dilek yazicioglu, Dr

    Diskapi Teaching and Research Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
DR

Study Record Dates

First Submitted

February 14, 2015

First Posted

April 8, 2015

Study Start

April 1, 2015

Primary Completion

June 1, 2015

Study Completion

July 1, 2015

Last Updated

September 12, 2017

Record last verified: 2015-02

Locations

TU(1)