Objective Vocal Cord Movement Assessment by C-Mac Videolaryngoscope Vs Airway Ultrasound in Ca ThyroidNCT02847780
Comparison of Two Technique for Assessment of Vocal Cord Movement by C-Mac Videolaryngoscope vs Airway Ultrasound.
A study testing Active Comparator :C-Mac Videolaryngoscope and Experimental: Airway ultrasound, in people with Objective Vocal Cord Movement Assessment by C-Mac Videolaryngoscope Vs Airway Ultrasound in Ca Thyroid, run by Rajiv Gandhi Cancer Institute & Research Center, India at 1 site in India.
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. Read more about this study
- Who is it for?
- Ages 17 to 70 years
- Conditions the study is for
- Objective Vocal Cord Movement Assessment by C-Mac Videolaryngoscope Vs Airway Ultrasound in Ca Thyroid
- What is being tested?
- Active Comparator :C-Mac Videolaryngoscope and Experimental: Airway ultrasound,
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIndia
- Study dates
- 20 Jul 2016to 10 Aug 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patient's undergoing thyroid and parathyroid surgery.
Who cannot join
- patients not extubated.
Trial locations and contacts
1 site in 1 country.
India1 site
Rajiv Gandhi Cancer Institute & Research center
Rohini, New Delhi, 110085
About this study
Official title: Assessment of Vocal Cord Movement After Thyroid Surgery Using C-MAC Video-laryngoscope and 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.
Read the 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.
- Being tested
- Active Comparator :C-Mac Videolaryngoscope, Experimental: Airway ultrasound,
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Comparator :C-Mac VideolaryngoscopeDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| C-Mac video laryngoscope. | Active comparator | Active Comparator: C-Mac Videolaryngoscope for vocal cord movement assessment. Receives: Device: Active Comparator :C-Mac Videolaryngoscope; Device: Experimental: Airway ultrasound, |
| Airway Ultrasound | Experimental | Experimental: Airway Ultrasound for vocal cord movement assessment. Receives: Device: Active Comparator :C-Mac Videolaryngoscope; Device: Experimental: Airway ultrasound, |
What is being measured
The primary outcome is the main question the study is designed to answer.
• 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.
Measured: At time of extubation.
Secondary outcomes (1)
• 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.
Measured: After extubation and before dressing.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2016 (estimated)
- Study start20 Jul 2016
- Primary completion19 Jul 2017
- Study completion10 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Objective Vocal Cord Movement Assessment by C-Mac Videolaryngoscope Vs Airway Ultrasound in Ca ThyroidStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rajiv Gandhi Cancer Institute & Research Center, India
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amit Kumar Mittal, Rajiv Gandhi Cancer Institute & Research Center, India
- Investigators
- Amit kr Mittal, M.D, Principal investigator, Rajiv Gandhi Cancer Institute & Research Centre, Rohini; New Delhi: India 110085.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02847780
- Sponsor's protocol ID
- 505/AN/AKM-03
- Status last verified
- Apr 2017
- First submitted
- 25 Jul 2016
- Last updated
- 17 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Vocal Cord Movement After Thyroid Surgery Using C-MAC Video-laryngoscope and Airway Ultrasound.
- ClinicalTrials.gov ID
- NCT02847780
- Acronym / sponsor ID
- 505/AN/AKM-03
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Rajiv Gandhi Cancer Institute & Research Center, IndiaUniversity, hospital or other
- Study start
- 20 Jul 2016 (actual)
- Primary completion
- 19 Jul 2017 (actual)
- Study completion
- 10 Aug 2017 (actual)
- First posted
- 28 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| C-Mac video laryngoscope. | Active comparator | Device: Active Comparator :C-Mac Videolaryngoscope, Device: Experimental: Airway ultrasound,Active Comparator: C-Mac Videolaryngoscope for vocal cord movement assessment. |
| Airway Ultrasound | Experimental | Device: Active Comparator :C-Mac Videolaryngoscope, Device: Experimental: Airway ultrasound,Experimental: Airway Ultrasound for vocal cord movement assessment. |
Who may qualify
- Ages
- 17 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patient's undergoing thyroid and parathyroid surgery.
Key exclusion criteria (1 listed)
- patients not extubated.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active Comparator :C-Mac VideolaryngoscopeReal time assessment of Glottic aperture at the time of extubation by videolaryngoscope | Device | Airway Ultrasound, C-Mac video laryngoscope. |
| Experimental: Airway ultrasound,Airway ultrasound using portable ultrasound machine to assess vocal cords movement. | Device | Airway Ultrasound, C-Mac video laryngoscope. |
Primary outcome
• 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.
1 secondary outcome
• 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2020.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amit kr Mittal, M.D principal investigator
Rajiv Gandhi Cancer Institute & Research Centre, Rohini; New Delhi: India 110085.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Comparator :C-Mac Videolaryngoscope and Experimental: Airway ultrasound, in people with Objective Vocal Cord Movement Assessment by C-Mac Videolaryngoscope Vs Airway Ultrasound in Ca Thyroid, run by Rajiv Gandhi Cancer Institute & Research Center, India at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
• To determine objective vocal cord mobility by the video laryngoscope and airway ultrasound (time frame: At time of extubation.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2020.