An interventional study of Active Comparator :C-Mac Videolaryngoscope and Experimental: Airway ultrasound, in Objective Vocal Cord Movement Assessment by C-Mac Videolaryngoscope Vs Airway Ultrasound in Ca Thyroid, sponsored by Rajiv Gandhi Cancer Institute & Research Center, India. Completed at 1 site in India. Open to participants aged 17 Years to 70 Years. Per ClinicalTrials.gov, last updated 2020-06-17.
Sponsored by Rajiv Gandhi Cancer Institute & Research Center, India · Not applicable, Interventional, and Diagnostic
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.
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.
967 studies on the registry are indexed under Thyroid Diseases; 197 are open to participants now.
This study's enrollment of 100 is above the median of 60 across 544 interventional studies indexed under Thyroid Diseases.
Browse Thyroid Diseases studies →Rajiv Gandhi Cancer Institute & Research Center, India is the lead sponsor of 25 studies on the registry; 3 are open to participants now.
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Active Comparator: C-Mac Videolaryngoscope for vocal cord movement assessment.
Device: Active Comparator :C-Mac Videolaryngoscope · Device: Experimental: Airway ultrasound,
Experimental: Airway Ultrasound for vocal cord movement assessment.
Device: Active Comparator :C-Mac Videolaryngoscope · Device: Experimental: Airway ultrasound,
Real time assessment of Glottic aperture at the time of extubation by videolaryngoscope
Airway ultrasound using portable ultrasound machine to assess vocal cords movement.
• 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.
Time frame: At time of extubation.
• 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.
Time frame: After extubation and before dressing.
Plan to share: No
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This study is completed, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.
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Rajiv Gandhi Cancer Institute & Research Center, India