Clinical trial NCT02847780: 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
Overall status: COMPLETED
Phase: NA
Conditions: Objective Vocal Cord Movement Assessment by C-Mac Videolaryngoscope Vs Airway Ultrasound in Ca Thyroid
Lead sponsor: Rajiv Gandhi Cancer Institute & Research Center, India
Sponsor class: OTHER
First posted: 2016-07-28
Enrollment: 100
Sex: ALL
Minimum age (years): 17
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: Inclusion Criteria:

* Patient's undergoing thyroid and parathyroid surgery.

Exclusion Criteria:

* patients not extubated.

Primary outcomes:
measure: • To determine objective vocal cord mobility by the video laryngoscope and airway ultrasound
timeFrame: At time of extubation.
Secondary outcomes:
measure: • To ascertain whether airway ultrasound can be used as a reliable alternative to assess post-operative vocal cord mobility
timeFrame: After extubation and before dressing.
Other outcomes:
Locations:
city: Rohini
country: India
facility: Rajiv Gandhi Cancer Institute & Research center
state: New Delhi
Study officials:
affiliation: Rajiv Gandhi Cancer Institute & Research Centre, Rohini; New Delhi: India 110085.
name: Amit kr Mittal, M.D
role: PRINCIPAL_INVESTIGATOR
References: