Laryngeal NerveNCT02395146
Neural Monitoring of the Superior Laryngeal Nerve in Thyroid Surgery
A study testing Monitoring in people with Laryngeal Nerve and Thyroid Surgery, run by The Royal Wolverhampton Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
Thyroid surgeons place an enormous amount of importance and rightly so to the preservation of the recurrent laryngeal nerve (RLN) during thyroidectomies. A good knowledge of the anatomy of the nerve and meticulous dissection technique and intraoperative identification of the nerve are crucial to the anatomic and… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Laryngeal Nerve, Thyroid Surgery
- What is being tested?
- Monitoring
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 9 Sep 2015to 1 Oct 2018
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing diagnostic hemithyroidectomies (thyroid nodules 5 cm or less).
- age 18 and over
- able to provide informed consent
Who cannot join
- Patients who develop a recurrent laryngeal nerve palsy following surgery will be excluded from the study.
- Patients who withdraw consent during or after study
- Patients with pre-existing laryngeal pathology like reinkes edema, vocal cord nodules, laryngeal inflammation, previous laryngeal surgery etc
- Pregnant women (confirmed by history and routine pregnancy test)
- Those unable to give informed consent
- Previous major neck surgery such as neck dissections, laryngeal surgery, carotid endarterectomies, parathyroid and thyroid surgery.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
The Royal Wolverhampton NHS Trust
Wolverhampton, West Midlands, WV10 0QP
About this study
Official title: Intra-operative Monitoring of the External Branch of the Superior Laryngeal Nerve (EBSLN) During Thyroid Surgery: Does it Improve Voice Preservation?
Thyroid surgeons place an enormous amount of importance and rightly so to the preservation of the recurrent laryngeal nerve (RLN) during thyroidectomies. A good knowledge of the anatomy of the nerve and meticulous dissection technique and intraoperative identification of the nerve are crucial to the anatomic and functional integrity of the nerve. The use of intraoperative neural monitoring to aid the surgeon in the identification of the RLN has gained acceptance and is considered standard practice in several units. However, lesser emphasis has been placed historically on the identification and preservation of the external branch of the superior laryngeal nerve (EBSLN) during thyroid surgery. The EBSLN supplies the cricothyroid muscle that controls pitch variation during phonation. Unlike damage to the recurrent laryngeal nerve which manifests readily as vocal cord paralysis, intraoperative damage to EBSLN is difficult to assess postoperatively as visual assessment of the larynx is not indicative of the integrity of the nerve. Injury of the EBSLN can cause weakness or complete paralysis of the ipsilateral cricothyroid muscle. Patients may report a deeper voice or an inability to produce high pitched sounds.
Patients may also complain of weakness, tightness of the voice, and require extra effort to speak. Of note, voice changes with EBSLN injury are subtle in the general population but can be devastating in patients who depend on their voice for a living. Importantly, EBSLN injury is reported in upto 50% of thyroid surgery in contrast to 12% of recurrent laryngeal nerve injury during thyroid surgery. The new guidelines published in the Laryngoscope recommend routine intraoperative neural monitoring of EBSLN. The Investigators have a functional system in use currently for monitoring recurrent laryngeal nerve intraoperatively and propose to study the impact of monitoring the EBSLN using the same neural monitoring device to improve voice results following thyroid surgery.
Read the detailed description
Thyroid surgery can result in change in the voice. This is because two nerves controlling the voice quality are situated very close anatomically to the thyroid gland and are at risk of damage during the surgery. One of the nerves that is called the recurrent laryngeal nerve controls the movements of the voice cords and is more readily identifiable and its injury is also detected easily by direct examination of the voice box as reduced/absent movement of the voice cord. It gets damaged in upto 1% of thyroid surgeries. The other nerve that is of interest to our study is called the superior laryngeal nerve, and its external branch (EBSLN) controls the pitch of the voice cord by supplying a muscle called the cricothyroid. This nerve is difficult to see and is reported to be damaged in 50% of thyroid surgeries. Its damage cannot be picked up on direct examination of the larynx and voice changes are subtle though devastating for individuals who depend on their voice for their livelihood singers actors etc. The Investigators would like to study if using a nerve monitor that is used to check the RLN during thyroid surgery can also be used to check the EBSLN. The Investigators hope that this could reduce the chances of damaging the nerve significantly. If the study shows good preservation of the EBSLN with the nerve monitor the Investigators will be able to make it a standard procedure during thyroid surgery.
The Investigators plan to recruit patients undergoing thyroid surgery involving one half of the thyroid gland. They will be given all the information about the study and consent will be obtained. If they agree to participate they will be divided into two groups randomly those who will have the intraoperative EBSLN monitoring and those who will not. All patients will have a preoperative voice assessment in the speech therapy unit which will involve filling in a voice questionnaire and undergoing a glottography (pitch assessment) They will then undergo the surgery Approximately 3 months after the surgery they will have another voice assessment using the voice questionnaire and the glottography. At this time they will also have an EMG assessment of the cricothyroid muscle which is the best method to check the function of the EBSLN. No further procedures/assessments will be undertaken.
- Conditions
- Laryngeal Nerve, Thyroid Surgery
- Being tested
- Monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MonitoringProcedure or surgery
intraoperative EBSLN monitoring
| Study group | Role | What they receive |
|---|---|---|
| Monitoring | Experimental | intraoperative EBSLN monitoring will take place Receives: Procedure: Monitoring |
| Non-Monitoring | No intervention | No intraoperative EBSLN monitoring will take place (standard practice) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intact external branch of the superior laryngeal nerve
Review and feedback via questionnaire of superior laryngeal nerve
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2015 (estimated)
- Study start9 Sep 2015
- Primary completion1 Oct 2018
- Study completion1 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laryngeal NerveStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Royal Wolverhampton Hospitals NHS Trust
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02395146
- Sponsor's protocol ID
- 14-04-06-SUR
- Status last verified
- Jun 2019
- First submitted
- 16 Mar 2015
- Last updated
- 19 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intra-operative Monitoring of the External Branch of the Superior Laryngeal Nerve (EBSLN) During Thyroid Surgery: Does it Improve Voice Preservation?
- ClinicalTrials.gov ID
- NCT02395146
- Acronym / sponsor ID
- 14-04-06-SUR
- Conditions
- Laryngeal Nerve, Thyroid Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- The Royal Wolverhampton Hospitals NHS TrustOther government
- Study start
- 9 Sep 2015 (actual)
- Primary completion
- 1 Oct 2018 (actual)
- Study completion
- 1 Oct 2018 (actual)
- First posted
- 20 Mar 2015 (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.
Thyroid surgeons place an enormous amount of importance and rightly so to the preservation of the recurrent laryngeal nerve (RLN) during thyroidectomies. A good knowledge of the anatomy of the nerve and meticulous dissection technique and intraoperative identification of the nerve are crucial to the anatomic and functional integrity of the nerve. The use of intraoperative neural monitoring to aid the surgeon in the identification of the RLN has gained acceptance and is considered standard practice in several units. However, lesser emphasis has been placed historically on the identification and preservation of the external branch of the superior laryngeal nerve (EBSLN) during thyroid surgery. The EBSLN supplies the cricothyroid muscle that controls pitch variation during phonation. Unlike damage to the recurrent laryngeal nerve which manifests readily as vocal cord paralysis, intraoperative damage to EBSLN is difficult to assess postoperatively as visual assessment of the larynx is not indicative of the integrity of the nerve. Injury of the EBSLN can cause weakness or complete paralysis of the ipsilateral cricothyroid muscle. Patients may report a deeper voice or an inability to produce high pitched sounds.
Patients may also complain of weakness, tightness of the voice, and require extra effort to speak. Of note, voice changes with EBSLN injury are subtle in the general population but can be devastating in patients who depend on their voice for a living. Importantly, EBSLN injury is reported in upto 50% of thyroid surgery in contrast to 12% of recurrent laryngeal nerve injury during thyroid surgery. The new guidelines published in the Laryngoscope recommend routine intraoperative neural monitoring of EBSLN. The Investigators have a functional system in use currently for monitoring recurrent laryngeal nerve intraoperatively and propose to study the impact of monitoring the EBSLN using the same neural monitoring device to improve voice results following thyroid surgery.
Detailed description
Thyroid surgery can result in change in the voice. This is because two nerves controlling the voice quality are situated very close anatomically to the thyroid gland and are at risk of damage during the surgery. One of the nerves that is called the recurrent laryngeal nerve controls the movements of the voice cords and is more readily identifiable and its injury is also detected easily by direct examination of the voice box as reduced/absent movement of the voice cord. It gets damaged in upto 1% of thyroid surgeries. The other nerve that is of interest to our study is called the superior laryngeal nerve, and its external branch (EBSLN) controls the pitch of the voice cord by supplying a muscle called the cricothyroid. This nerve is difficult to see and is reported to be damaged in 50% of thyroid surgeries. Its damage cannot be picked up on direct examination of the larynx and voice changes are subtle though devastating for individuals who depend on their voice for their livelihood singers actors etc. The Investigators would like to study if using a nerve monitor that is used to check the RLN during thyroid surgery can also be used to check the EBSLN. The Investigators hope that this could reduce the chances of damaging the nerve significantly. If the study shows good preservation of the EBSLN with the nerve monitor the Investigators will be able to make it a standard procedure during thyroid surgery.
The Investigators plan to recruit patients undergoing thyroid surgery involving one half of the thyroid gland. They will be given all the information about the study and consent will be obtained. If they agree to participate they will be divided into two groups randomly those who will have the intraoperative EBSLN monitoring and those who will not. All patients will have a preoperative voice assessment in the speech therapy unit which will involve filling in a voice questionnaire and undergoing a glottography (pitch assessment) They will then undergo the surgery Approximately 3 months after the surgery they will have another voice assessment using the voice questionnaire and the glottography. At this time they will also have an EMG assessment of the cricothyroid muscle which is the best method to check the function of the EBSLN. No further procedures/assessments will be undertaken.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Monitoring | Experimental | Procedure: Monitoringintraoperative EBSLN monitoring will take place |
| Non-Monitoring | No intervention | –No intraoperative EBSLN monitoring will take place (standard practice) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients undergoing diagnostic hemithyroidectomies (thyroid nodules 5 cm or less).
- age 18 and over
- able to provide informed consent
Key exclusion criteria (6 listed)
- Patients who develop a recurrent laryngeal nerve palsy following surgery will be excluded from the study.
- Patients who withdraw consent during or after study
- Patients with pre-existing laryngeal pathology like reinkes edema, vocal cord nodules, laryngeal inflammation, previous laryngeal surgery etc
- Pregnant women (confirmed by history and routine pregnancy test)
- Those unable to give informed consent
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 |
|---|---|---|
| Monitoringintraoperative EBSLN monitoring | Procedure or surgery | Monitoring |
Primary outcome
Intact external branch of the superior laryngeal nerve
Time frame: 6 months
Review and feedback via questionnaire of superior laryngeal nerve
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 19 Jun 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Monitoring in people with Laryngeal Nerve and Thyroid Surgery, run by The Royal Wolverhampton Hospitals NHS Trust at 1 site in United Kingdom.
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 3 inclusion and 6 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 19 Jun 2019. 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 United Kingdom. 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?
Intact external branch of the superior laryngeal nerve (time frame: 6 months). 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 19 Jun 2019.