Vocal Cord Movement Assessment by Airway UltrasoundNCT02847819
Vocal Cord Movement Assessment Using Airway Ultrasound.
An observational study of Vocal Cord Movement Assessment by Airway Ultrasound, run by Rajiv Gandhi Cancer Institute & Research Center, India at 1 site in India.
Trial summary
Total of 100 patients are included in this is a prospective observational study to evaluate the role of airway ultrasound (USG) in assessing vocal cord mobility in patients undergoing thyroid surgery. patients will be scanned preoperatively by airway ultrasound which will be compared to post operative ultrasound scans. Read more about this study
- Who is it for?
- Ages 17 to 70 years
- Conditions the study is for
- Vocal Cord Movement Assessment by Airway Ultrasound
- What is being tested?
- airway ultrasound for vocal cords movement assessment.
- Type of treatment
- Medical device
- How many people
- 104 participants
- Where
- 1 siteIndia
- Study dates
- 2 Jul 2016to 25 Aug 2017
- How long will I take part?
- 30 Days
- Phase
- Observational
- 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
Study population: patients undergoing thyroid surgery.
Who may be able to join
- patients undergoing thyroid surgery between specified age limits.
Who cannot join
- Retro sternal goiters.
Trial locations and contacts
1 site in 1 country.
India1 site
Rajiv Gandhi Cancer Institute & Research center
Delhi, New Delhi, 110085
About this study
Official title: Pre and Post-operative Evaluation of Vocal Cord Movement in Patients Undergoing Thyroid Surgery by Airway Ultrasound Scanning.
Total of 100 patients are included in this is a prospective observational study to evaluate the role of airway ultrasound (USG) in assessing vocal cord mobility in patients undergoing thyroid surgery. patients will be scanned preoperatively by airway ultrasound which will be compared to post operative ultrasound scans.
Read the detailed description
All 100 patients between age groups of 15-70 years, will be scanned pre-operatively to see vocal cord mobility as a reference value. A proper acoustic window is mandatory for optimal visualization of laryngeal structures. 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, when both false vocal cords are visible (score1-2), along with false cord when both arytenoids are visible scored good (score3-4) and if single or both true vocal cords are visible then scored as very good(score5-6). After the surgery the same patient will be scanned again for vocal cord mobility at 4hours of extubation . Any change in mobility will be recorded. If any change will be observed, direct laryngoscopy (DL) will be done to confirm the diagnosis. Any complication in the post-operative period will be recorded.
- Being tested
- airway ultrasound for vocal cords movement assessment.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
airway ultrasound for vocal cords movement assessment.Device
Glottic aperture will be scanned using 7.5 megahertz (MHz) linear transducer portable ultrasound machine. after getting the best acoustic window, true, false vocal cords arytenoid movements will be visualized. Individual cord will be focused and doppler velocity will be measured for both the cords.
| Study group | Role | What they receive |
|---|---|---|
| Vocal cords movement assessment by airway USG. | Preoperatively patients undergoing thyroid surgery will be scanned by airway ultrasound and graded for vocal cord movement, the same group of patients will be again scanned and graded by airway ultrasound at 4th post operative hours. Receives: Device: airway ultrasound for vocal cords movement assessment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective confirmation of vocal cords movement
Measured: pre operatively and at 4 hours after extubation
Secondary outcomes (1)
Comparison of preoperative doppler velocity with post operative doppler velocity.
Measured: At 4 hours after extubation.
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 start2 Jul 2016
- Primary completion17 Aug 2017
- Study completion25 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vocal Cord Movement Assessment by Airway UltrasoundStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 104 participants (actual)
- Target duration
- 30 Days
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
- Mamta Dubey, M.D, Principal investigator, Rajiv Gandhi Cancer Institute & Research Centre, Rohini; New Delhi: India 110085.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02847819
- Sponsor's protocol ID
- RGCI ID: 506/AN/AKM-04
- Status last verified
- Apr 2017
- First submitted
- 25 Jul 2016
- Last updated
- 18 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Dubey M, Mittal AK, Jaipuria J, Arora M, Dewan AK, Pahade A. Functional analysis of vocal folds by transcutaneous laryngeal ultrasonography in patients undergoing thyroidectomy. Acta Anaesthesiol Scand. 2019 Feb;63(2):178-186. doi: 10.1111/aas.13234. Epub 2018 Aug 5.
PubMed 30079464
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre and Post-operative Evaluation of Vocal Cord Movement in Patients Undergoing Thyroid Surgery by Airway Ultrasound Scanning.
- ClinicalTrials.gov ID
- NCT02847819
- Acronym / sponsor ID
- RGCI ID: 506/AN/AKM-04
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Rajiv Gandhi Cancer Institute & Research Center, IndiaUniversity, hospital or other
- Study start
- 2 Jul 2016 (actual)
- Primary completion
- 17 Aug 2017 (actual)
- Study completion
- 25 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.
Total of 100 patients are included in this is a prospective observational study to evaluate the role of airway ultrasound (USG) in assessing vocal cord mobility in patients undergoing thyroid surgery. patients will be scanned preoperatively by airway ultrasound which will be compared to post operative ultrasound scans.
Detailed description
All 100 patients between age groups of 15-70 years, will be scanned pre-operatively to see vocal cord mobility as a reference value. A proper acoustic window is mandatory for optimal visualization of laryngeal structures. 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, when both false vocal cords are visible (score1-2), along with false cord when both arytenoids are visible scored good (score3-4) and if single or both true vocal cords are visible then scored as very good(score5-6). After the surgery the same patient will be scanned again for vocal cord mobility at 4hours of extubation . Any change in mobility will be recorded. If any change will be observed, direct laryngoscopy (DL) will be done to confirm the diagnosis. Any complication in the post-operative period will be recorded.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 30 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vocal cords movement assessment by airway USG. | – | Device: airway ultrasound for vocal cords movement assessment.Preoperatively patients undergoing thyroid surgery will be scanned by airway ultrasound and graded for vocal cord movement, the same group of patients will be again scanned and graded by airway ultrasound at 4th post operative hours. |
Who may qualify
- Ages
- 17 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients undergoing thyroid surgery.
Key inclusion criteria (1 listed)
- patients undergoing thyroid surgery between specified age limits.
Key exclusion criteria (1 listed)
- Retro sternal goiters.
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 |
|---|---|---|
| airway ultrasound for vocal cords movement assessment.Glottic aperture will be scanned using 7.5 megahertz (MHz) linear transducer portable ultrasound machine. after getting the best acoustic window, true, false vocal cords arytenoid movements will be visualized. Individual cord will be focused and doppler velocity will be measured for both the cords. | Device | Vocal cords movement assessment by airway USG. |
Primary outcome
Objective confirmation of vocal cords movement
Time frame: pre operatively and at 4 hours after extubation
1 secondary outcome
Comparison of preoperative doppler velocity with post operative doppler velocity.
Time frame: At 4 hours after extubation.
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 18 Jun 2020.
- Derived from this study: PubMed 30079464Dubey M, Mittal AK, Jaipuria J, Arora M, Dewan AK, Pahade A. Functional analysis of vocal folds by transcutaneous laryngeal ultrasonography in patients undergoing thyroidectomy. Acta Anaesthesiol Scand. 2019 Feb;63(2):178-186. doi: 10.1111/aas.13234. Epub 2018 Aug 5.
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.
Mamta Dubey, 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?
An observational study of Vocal Cord Movement Assessment by Airway Ultrasound, 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 18 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?
Objective confirmation of vocal cords movement (time frame: pre operatively and at 4 hours after extubation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02847819, which also lists 1 linked publication.
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 18 Jun 2020.