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

Assessment of Vocal Cord Movement After Thyroid Surgery Using C-MAC Video-laryngoscope and Airway Ultrasound.

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.

Study Overview

• Status: Completed
• Conditions: Objective Vocal Cord Movement Assessment by C-Mac Videolaryngoscope Vs Airway Ultrasound in Ca Thyroid
• Intervention / Treatment: Device: Active Comparator :C-Mac Videolaryngoscope; Device: Experimental: Airway ultrasound,

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years to 70 years (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patient's undergoing thyroid and parathyroid surgery.

Exclusion Criteria:

• patients not extubated.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: C-Mac video laryngoscope.; Active Comparator: C-Mac Videolaryngoscope for vocal cord movement assessment.	Device: Active Comparator :C-Mac Videolaryngoscope; Real time assessment of Glottic aperture at the time of extubation by videolaryngoscope; Device: Experimental: Airway ultrasound,; Airway ultrasound using portable ultrasound machine to assess vocal cords movement.
EXPERIMENTAL: Airway Ultrasound; Experimental: Airway Ultrasound for vocal cord movement assessment.	Device: Active Comparator :C-Mac Videolaryngoscope; Real time assessment of Glottic aperture at the time of extubation by videolaryngoscope; Device: Experimental: Airway ultrasound,; Airway ultrasound using portable ultrasound machine to assess vocal cords movement.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
• 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
• To ascertain whether airway ultrasound can be used as a reliable alternative to assess post-operative vocal cord mobility	After extubation with aseptic precaution patient's airway will be scanned for vocal cord movement assessment.	After extubation and before dressing.

Collaborators and Investigators

• Sponsor: Rajiv Gandhi Cancer Institute & Research Center, India
• Investigators: Principal Investigator: Amit kr Mittal, M.D, Rajiv Gandhi Cancer Institute & Research Centre, Rohini; New Delhi: India 110085.

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 20, 2016
• Primary Completion (ACTUAL): July 19, 2017
• Study Completion (ACTUAL): August 10, 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 17, 2020
• Last Update Submitted That Met QC Criteria: June 16, 2020
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Thyroid Diseases
• Other Study ID Numbers: 505/AN/AKM-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO