Completed

NCT Number: NCT02847819

Vocal Cord Movement Assessment Using Airway Ultrasound.

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.

Completed

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Key information

Conditions

Vocal Cord Movement Assessment by Airway Ultrasound

Age range

17 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Rajiv Gandhi Cancer Institute & Research center

Delhi, New Delhi, 110085, India

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

patients undergoing thyroid surgery between specified age limits.

Exclusion criteria

Retro sternal goiters.

Treatment and study plan

airway ultrasound for vocal cords movement assessment.

Device

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.

Primary outcomes

Objective confirmation of vocal cords movement

Time frame: pre operatively and at 4 hours after extubation

Secondary outcomes

Comparison of preoperative doppler velocity with post operative doppler velocity.

Time frame: At 4 hours after extubation.

Sponsors and collaborators

Lead sponsor

Rajiv Gandhi Cancer Institute & Research Center, India

Other

Registry information

Official study title

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

Important dates

Study start: 2016
Primary completion: 2017
Study completion: 2017
First posted: Jul 28, 2016
Registry last updated: Jun 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.