Completed

NCT Number: NCT02847780

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

Completed

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Key information

Conditions

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

Age range

17 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rajiv Gandhi Cancer Institute & Research center

Rohini, New Delhi, 110085, India

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patient's undergoing thyroid and parathyroid surgery.

Exclusion criteria

patients not extubated.

Treatment and study plan

Active Comparator :C-Mac Videolaryngoscope

Device

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

Experimental: Airway ultrasound,

Device

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

Primary outcomes

• To determine objective vocal cord mobility by the video laryngoscope and airway ultrasound

Time frame: At time of extubation.

patients vocal cords will be assessed by videolaryngoscope at time of extubation then the cords will be again assessed by airway ultrasound.

Secondary outcomes

• To ascertain whether airway ultrasound can be used as a reliable alternative to assess post-operative vocal cord mobility

Time frame: After extubation and before dressing.

After extubation with aseptic precaution patient's airway will be scanned for vocal cord movement assessment.

Sponsors and collaborators

Lead sponsor

Rajiv Gandhi Cancer Institute & Research Center, India

Other

Registry information

Official study title

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

Important dates

Study start: 2016
Primary completion: 2017
Study completion: 2017
First posted: Jul 28, 2016
Registry last updated: Jun 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.