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

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

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02847780
• Other study ID #: 505/AN/AKM-03
• Status: Completed
• Phase: N/A
• Start date: July 20, 2016
• Est. completion date: August 10, 2017

Study information

• Verified date: April 2017
• Source: Rajiv Gandhi Cancer Institute & Research Center, India
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: August 10, 2017
• Est. primary completion date: July 19, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 17 Years to 70 Years

Eligibility

Inclusion Criteria:

• Patient's undergoing thyroid and parathyroid surgery.

Exclusion Criteria:

• patients not extubated.

Related Conditions & MeSH terms

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

Intervention

Device:
• Active Comparator :C-Mac Videolaryngoscope
Real time assessment of Glottic aperture at the time of extubation by videolaryngoscope
• Experimental: Airway ultrasound,
Airway ultrasound using portable ultrasound machine to assess vocal cords movement.

Locations

Country	Name	City	State
India	Rajiv Gandhi Cancer Institute & Research center	Rohini	New Delhi

Sponsors (1)

Lead Sponsor	Collaborator
Rajiv Gandhi Cancer Institute & Research Center, India

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	• 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	• 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.