NCT02847780

Brief Summary

This study is planned to compare C-Mac video-laryngoscope and airway ultrasound as two novel techniques (causing least discomfort to the patients) for the detection of impaired vocal-cord movement after thyroid surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 20, 2016

Completed
5 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
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 19, 2017

Completed
22 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 10, 2017

Completed
Last Updated

June 17, 2020

Status Verified

April 1, 2017

Enrollment Period

12 months

First QC Date

July 25, 2016

Last Update Submit

June 16, 2020

Conditions

Objective Vocal Cord Movement Assessment by C-Mac Videolaryngoscope Vs Airway Ultrasound in Ca Thyroid

Outcome Measures

Primary Outcomes (1)

  • • To determine objective vocal cord mobility by the video laryngoscope and airway ultrasound

    patients vocal cords will be assessed by videolaryngoscope at time of extubation then the cords will be again assessed by airway ultrasound.

    At time of extubation.

Secondary Outcomes (1)

  • • To ascertain whether airway ultrasound can be used as a reliable alternative to assess post-operative vocal cord mobility

    After extubation and before dressing.

Study Arms (2)

C-Mac video laryngoscope.

ACTIVE COMPARATOR

Active Comparator: C-Mac Videolaryngoscope for vocal cord movement assessment.

Device: Active Comparator :C-Mac VideolaryngoscopeDevice: Experimental: Airway ultrasound,

Airway Ultrasound

EXPERIMENTAL

Experimental: Airway Ultrasound for vocal cord movement assessment.

Device: Active Comparator :C-Mac VideolaryngoscopeDevice: Experimental: Airway ultrasound,

Interventions

Active Comparator :C-Mac VideolaryngoscopeDEVICE

Real time assessment of Glottic aperture at the time of extubation by videolaryngoscope

Airway UltrasoundC-Mac video laryngoscope.
Experimental: Airway ultrasound,DEVICE

Airway ultrasound using portable ultrasound machine to assess vocal cords movement.

Airway UltrasoundC-Mac video laryngoscope.

Eligibility Criteria

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

You may qualify if:

  • Patient's undergoing thyroid and parathyroid surgery.

You may not qualify if:

  • patients not extubated.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rajiv Gandhi Cancer Institute & Research center

Rohini, New Delhi, 110085, India

Location

Study Officials

  • Amit kr Mittal, M.D

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant in-charge

Study Record Dates

First Submitted

July 25, 2016

First Posted

July 28, 2016

Study Start

July 20, 2016

Primary Completion

July 19, 2017

Study Completion

August 10, 2017

Last Updated

June 17, 2020

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share

Locations

IN(1)