Comparison of Two Technique for Assessment of Vocal Cord Movement by C-Mac Videolaryngoscope vs Airway Ultrasound.

NCT ID: NCT02847780

Last Updated: 2020-06-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-20

Study Completion Date

2017-08-10

Brief Summary

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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.

Detailed Description

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In this prospective study 100 patients posted for Thyroid surgery will be included, after explaining the procedure and written informed consent, all included patients in the study will be assessed for vocal cord mobility by C-Mac video laryngoscope (manufactured by KARL STORZ Video Laryngoscopes) followed by airway ultrasonography (USG). Linear transducer (7.5 MHz) will be used for scanning the airway placed at the level of thyroid cartilage with 10-15 degree cephalad tilt so to get proper acoustic window and for optimal visualization of laryngeal structures. C-Mac video laryngoscope will be required for virtual visualization of glottis apertures and vocal cord movement. All patients will be scanned pre-operatively by indirect laryngoscopy to see vocal cord mobility as a reference value. Immediately after extubation the patient will be scanned for vocal cord mobility by videolaryngoscope by first examiner, After oxygenation and stabilization of haemodynamic, ultrasound of airway will be performed to study the vocal cord movement by the other examiner (blinded to the laryngoscopy finding).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 (score1-2), good(score3-4) and very good(score5-6) Findings of both the examiners will be collected by the primary investigator for data collection and analysis.

Conditions

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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Caregivers

Study Groups

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C-Mac video laryngoscope.

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

Group Type ACTIVE_COMPARATOR

Active Comparator :C-Mac Videolaryngoscope

Intervention Type DEVICE

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

Experimental: Airway ultrasound,

Intervention Type DEVICE

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

Airway Ultrasound

Experimental: Airway Ultrasound for vocal cord movement assessment.

Group Type EXPERIMENTAL

Active Comparator :C-Mac Videolaryngoscope

Intervention Type DEVICE

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

Experimental: Airway ultrasound,

Intervention Type DEVICE

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

Interventions

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Active Comparator :C-Mac Videolaryngoscope

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

Intervention Type DEVICE

Experimental: Airway ultrasound,

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patient's undergoing thyroid and parathyroid surgery.

Exclusion Criteria

* patients not extubated.
Minimum Eligible Age

17 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rajiv Gandhi Cancer Institute & Research Center, India

OTHER

Sponsor Role lead

Responsible Party

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Amit Kumar Mittal

Consultant in-charge

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Amit kr Mittal, M.D

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Rajiv Gandhi Cancer Institute & Research center

Rohini, New Delhi, India

Site Status

Countries

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India

Other Identifiers

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505/AN/AKM-03

Identifier Type: -

Identifier Source: org_study_id

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