Vocal Cord Movement Assessment Using Airway Ultrasound.

June 16, 2020 updated by: Amit Kumar Mittal, Rajiv Gandhi Cancer Institute & Research Center, India

Pre and Post-operative Evaluation of Vocal Cord Movement in Patients Undergoing Thyroid Surgery by Airway Ultrasound Scanning.

Total of 100 patients are included in this is a prospective observational study to evaluate the role of airway ultrasound (USG) in assessing vocal cord mobility in patients undergoing thyroid surgery. patients will be scanned preoperatively by airway ultrasound which will be compared to post operative ultrasound scans.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

All 100 patients between age groups of 15-70 years, will be scanned pre-operatively to see vocal cord mobility as a reference value. A proper acoustic window is mandatory for optimal visualization of laryngeal structures. Visibility of false vocal cords, true vocal cords and arytenoids will be given one point each for one side, maximal score will be 6. According to points the acoustic window scoring for glottis aperture will be graded as fair, when both false vocal cords are visible (score1-2), along with false cord when both arytenoids are visible scored good (score3-4) and if single or both true vocal cords are visible then scored as very good(score5-6). After the surgery the same patient will be scanned again for vocal cord mobility at 4hours of extubation . Any change in mobility will be recorded. If any change will be observed, direct laryngoscopy (DL) will be done to confirm the diagnosis. Any complication in the post-operative period will be recorded.

Study Type

Observational

Enrollment (Actual)

104

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • New Delhi
      • Delhi, New Delhi, India, 110085
        • Rajiv Gandhi Cancer Institute & Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years to 70 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

patients undergoing thyroid surgery.

Description

Inclusion Criteria:

  • patients undergoing thyroid surgery between specified age limits.

Exclusion Criteria:

  • Retro sternal goiters.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Vocal cords movement assessment by airway USG.
Preoperatively patients undergoing thyroid surgery will be scanned by airway ultrasound and graded for vocal cord movement, the same group of patients will be again scanned and graded by airway ultrasound at 4th post operative hours.
Device: airway ultrasound for vocal cords movement assessment.
Glottic aperture will be scanned using 7.5 megahertz (MHz) linear transducer portable ultrasound machine. after getting the best acoustic window, true, false vocal cords arytenoid movements will be visualized. Individual cord will be focused and doppler velocity will be measured for both the cords.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Objective confirmation of vocal cords movement
Time Frame: pre operatively and at 4 hours after extubation
pre operatively and at 4 hours after extubation

Secondary Outcome Measures

Outcome Measure
Time Frame
Comparison of preoperative doppler velocity with post operative doppler velocity.
Time Frame: At 4 hours after extubation.
At 4 hours after extubation.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rajiv Gandhi Cancer Institute & Research Center, India

Investigators

  • Principal Investigator: Mamta Dubey, M.D, Rajiv Gandhi Cancer Institute & Research Centre, Rohini; New Delhi: India 110085.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 2, 2016

Primary Completion (Actual)

August 17, 2017

Study Completion (Actual)

August 25, 2017

Study Registration Dates

First Submitted

July 25, 2016

First Submitted That Met QC Criteria

July 27, 2016

First Posted (Estimate)

July 28, 2016

Study Record Updates

Last Update Posted (Actual)

June 18, 2020

Last Update Submitted That Met QC Criteria

June 16, 2020

Last Verified

April 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • RGCI ID: 506/AN/AKM-04

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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