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Vocal Cord Movement: Comparison of Trans Thyroid and Supra Thyroid View in ultrasound

Protocol summary

Summary
Objectives:This study was designed to assess the efficiency of ultra(sound as a screening tool for the detection of impaired vocal-cord movement and compare two sonographic view , supra thyroid and trans thyroid, to find which view is preferred to observation of movement of vocal cord in different ages and sexes. Design : In this clinical trial 144 (18- 80 years old) patient were evaluated. All patients underwent vocal cord sonography in tow sonographic view, Trans thyroid and supra thyroid, before and after surgery. After high risk surgery for vocal cord damage alike thyroidectomy, parathyroidectomy ,Carotid endartrectomy, anterior approach of cervical spine fixation and thoracic procedure ,s Patient underwent direct laryngoscopy. To assess accuracy of ultrasound, Trans cutaneous sonography findings were correlated with direct laryngoscopy findings after extubating. Vocal cord Paresis or palsy defined as abnormal vocal cord movement during respiration. Key words: vocal cord, ultrasonography, Trans thyroid view, supra thyroid view , airway.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016060628311N1
Registration date: 2017-05-06, 1396/02/16
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-05-06, 1396/02/16
Registrant information
Name
sara ahmadi
Name of organization / entity
resident of anesthesia
Country
Iran (Islamic Republic of)
Phone
+98 21 4433 9115
Email address
drahmadi1396@gmail.com
Recruitment status
Recruitment complete
Funding source
Medical school of Iran University of medical sciences
Expected recruitment start date
2014-05-31, 1393/03/10
Expected recruitment end date
2016-01-31, 1394/11/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Vocal Cord Movement: Comparison of Trans Thyroid and Supra Thyroid View in ultrasound
Public title
The Use of Ultrasound to Diagnosis Vocal Cord Movement: Comparison of Trans Thyroid and Supra Thyroid View
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclution criteria: Patients (8-18 years old) that admitted in general operating room Exclusion criteria:Know patients with abnormal movement of the vocal cord in ultrasonography, patient with dysphonia despite apparently normal laryngeal ultrasonography
Age
From 18 years old to 88 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 144
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
randomization using random number table

Secondary Ids

1

Registry name
___
Secondary trial Id
___
Registration date
empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Iran university of medical sciences
Street address
hemmat highway
City
Tehran
Postal code
Approval date
2017-01-19, 1395/10/30
Ethics committee reference number
IR.IUMS.REC 1395.9211174002

Health conditions studied

1

Description of health condition studied
vocal-cord movement assessment
ICD-10 code
XIX
ICD-10 code description
T80-T88

Primary outcomes

1

Description
vocal cord movement
Timepoint
after the end of surgery
Method of measurement
observation and grading the quality of images

Secondary outcomes

1

Description
don't have
Timepoint
...
Method of measurement
...

Intervention groups

1

Description
Intervention group 1: Using the ultrasound with supra thyroid view for the evaluation of vocal cord movement
Category
Diagnosis

2

Description
Intervention group 2: Using the ultrasound with trans thyroid view for the evaluation of vocal cord movement
Category
Diagnosis

3

Description
Control group: Using direct laryngoscopy for the evaluation of vocal cord movement
Category
Diagnosis

Recruitment centers

1

Recruitment center
Name of recruitment center
Tehran, satarkhan street, Rasool akram hospital
Full name of responsible person
Dr masood mohseni
Street address
Tehran, satarkhan street, Rasool akram hospital, Department of anesthesiology
City
tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran university of medical sciences
Full name of responsible person
vice Chancellor for research of Iran university of medical sciences , Dr Mehrdad Eftekhar
Street address
school of Medicine, Iran university of medical sciences, Hemmat Highway
City
tehran
Grant name
___
Grant code / Reference number
___
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran university of medical sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Rasool Akram hospital
Full name of responsible person
Dr Masood Mohseni
Position
Assistant professor
Other areas of specialty/work
Street address
Sattarkhan street
City
Tehran
Postal code
Phone
+98 21 6435 2326
Fax
Email
masood.mohseni@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Rasool Akram hospital
Full name of responsible person
Dr Masood Mohseni
Position
assistant professor
Other areas of specialty/work
Street address
Sattarkhan street
City
Tehran
Postal code
Phone
+98 21 6435 2326
Fax
Email
masood.mohseni@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Rasool Akram hospital
Full name of responsible person
masood.mohseni
Position
assistant professor
Other areas of specialty/work
Street address
Sattarkhan street
City
Tehran
Postal code
Phone
+98 21 6435 2326
Fax
Email
masood.mohseni@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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