NCT02847819

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
104

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2016

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 2, 2016

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

July 25, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 28, 2016

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 17, 2017

Completed
8 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 25, 2017

Completed
Last Updated

June 18, 2020

Status Verified

April 1, 2017

Enrollment Period

1.1 years

First QC Date

July 25, 2016

Last Update Submit

June 16, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Objective confirmation of vocal cords movement

    pre operatively and at 4 hours after extubation

Secondary Outcomes (1)

  • Comparison of preoperative doppler velocity with post operative doppler velocity.

    At 4 hours after extubation.

Study Arms (1)

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.

Interventions

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.

Vocal cords movement assessment by airway USG.

Eligibility Criteria

Age17 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients undergoing thyroid surgery.

You may qualify if:

  • patients undergoing thyroid surgery between specified age limits.

You may not qualify if:

  • Retro sternal goiters.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rajiv Gandhi Cancer Institute & Research center

Delhi, New Delhi, 110085, India

Location

Related Publications (1)

  • Dubey M, Mittal AK, Jaipuria J, Arora M, Dewan AK, Pahade A. Functional analysis of vocal folds by transcutaneous laryngeal ultrasonography in patients undergoing thyroidectomy. Acta Anaesthesiol Scand. 2019 Feb;63(2):178-186. doi: 10.1111/aas.13234. Epub 2018 Aug 5.

Study Officials

  • Mamta Dubey, M.D

    Rajiv Gandhi Cancer Institute & Research Centre, Rohini; New Delhi: India 110085.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
30 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

July 25, 2016

First Posted

July 28, 2016

Study Start

July 2, 2016

Primary Completion

August 17, 2017

Study Completion

August 25, 2017

Last Updated

June 18, 2020

Record last verified: 2017-04

Locations