Back to resultsComparison of Two Technique for Assessment of Vocal Cord Movement by C-Mac Videolaryngoscope vs Airway Ultrasound.
Primary Purpose
Objective Vocal Cord Movement Assessment by C-Mac Videolaryngoscope Vs Airway Ultrasound in Ca Thyroid
Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Active Comparator :C-Mac Videolaryngoscope
Experimental: Airway ultrasound,
Sponsored by
About this trial
This is an interventional diagnostic trial for Objective Vocal Cord Movement Assessment by C-Mac Videolaryngoscope Vs Airway Ultrasound in Ca Thyroid
Eligibility Criteria
Inclusion Criteria:
- Patient's undergoing thyroid and parathyroid surgery.
Exclusion Criteria:
- patients not extubated.
Sites / Locations
- Rajiv Gandhi Cancer Institute & Research center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
C-Mac video laryngoscope.
Airway Ultrasound
Arm Description
Active Comparator: C-Mac Videolaryngoscope for vocal cord movement assessment.
Experimental: Airway Ultrasound for vocal cord movement assessment.
Outcomes
Primary Outcome Measures
• 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.
Secondary Outcome Measures
• 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.
Full Information
NCT ID
NCT02847780
First Posted
July 25, 2016
Last Updated
June 16, 2020
Sponsor
Rajiv Gandhi Cancer Institute & Research Center, India
1. Study Identification
Unique Protocol Identification Number
NCT02847780
Brief Title
Comparison of Two Technique for Assessment of Vocal Cord Movement by C-Mac Videolaryngoscope vs Airway Ultrasound.
Official Title
Assessment of Vocal Cord Movement After Thyroid Surgery Using C-MAC Video-laryngoscope and Airway Ultrasound.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
July 20, 2016 (Actual)
Primary Completion Date
July 19, 2017 (Actual)
Study Completion Date
August 10, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rajiv Gandhi Cancer Institute & Research Center, India
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Objective Vocal Cord Movement Assessment by C-Mac Videolaryngoscope Vs Airway Ultrasound in Ca Thyroid
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Non-Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
C-Mac video laryngoscope.
Arm Type
Active Comparator
Arm Description
Active Comparator: C-Mac Videolaryngoscope for vocal cord movement assessment.
Arm Title
Airway Ultrasound
Arm Type
Experimental
Arm Description
Experimental: Airway Ultrasound for vocal cord movement assessment.
Intervention Type
Device
Intervention Name(s)
Active Comparator :C-Mac Videolaryngoscope
Intervention Description
Real time assessment of Glottic aperture at the time of extubation by videolaryngoscope
Intervention Type
Device
Intervention Name(s)
Experimental: Airway ultrasound,
Intervention Description
Airway ultrasound using portable ultrasound machine to assess vocal cords movement.
Primary Outcome Measure Information:
Title
• To determine objective vocal cord mobility by the video laryngoscope and airway ultrasound
Description
patients vocal cords will be assessed by videolaryngoscope at time of extubation then the cords will be again assessed by airway ultrasound.
Time Frame
At time of extubation.
Secondary Outcome Measure Information:
Title
• To ascertain whether airway ultrasound can be used as a reliable alternative to assess post-operative vocal cord mobility
Description
After extubation with aseptic precaution patient's airway will be scanned for vocal cord movement assessment.
Time Frame
After extubation and before dressing.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
17 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient's undergoing thyroid and parathyroid surgery.
Exclusion Criteria:
patients not extubated.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amit kr Mittal, M.D
Organizational Affiliation
Rajiv Gandhi Cancer Institute & Research Centre, Rohini; New Delhi: India 110085.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rajiv Gandhi Cancer Institute & Research center
City
Rohini
State/Province
New Delhi
ZIP/Postal Code
110085
Country
India
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Comparison of Two Technique for Assessment of Vocal Cord Movement by C-Mac Videolaryngoscope vs Airway Ultrasound.
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