Thyroid DiseaseCIONM-SSCNCT07710365
Individualized Supramaximal Stimulation Current During Continuous Neuromonitoring in Thyroid Surgery
An observational study of Thyroid Disease, run by Medical University of Gdansk at 1 site in Poland.
Trial summary
Continuous intraoperative neuromonitoring (C-IONM) is increasingly used during thyroid surgery to detect early changes in recurrent laryngeal nerve function and reduce the risk of nerve injury. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thyroid Disease
- What is being tested?
- Continuous intraoperative neuromonitoring with fixed stimulation current and Continuous intraoperative neuromonitoring with individualized stimulation current
- Type of treatment
- Surgery or procedure
- How many people
- 623 participants
- Where
- 1 sitePoland
- Study dates
- 18 Jun 2020to 11 Feb 2025
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population consisted of consecutive adult patients who underwent thyroid surgery with continuous intraoperative neuromonitoring (C-IONM) at the Department of Endocrine and General Surgery, Medical University of Gdańsk, Poland, between June 2020 and July 2024. Patients were identified retrospectively from the institutional thyroid surgery database and neuromonitoring records. Clinical and operative data were collected as part of routine clinical care. Participants were included consecutively during the study period.
Who may be able to join
- Adults aged 18 years or older.
- Patients undergoing thyroid surgery with continuous intraoperative neuromonitoring (C-IONM) of the vagus nerve.
- Availability of complete intraoperative neuromonitoring recordings suitable for analysis.
- Availability of complete clinical and operative data.
Who cannot join
- Age younger than 18 years.
- Incomplete or technically inadequate neuromonitoring recordings.
- Loss of signal or recurrent laryngeal nerve palsy preventing reliable amplitude analysis.
- Missing or incomplete clinical data required for the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Patient-Specific Determination of Supramaximal Stimulation Current During Continuous Intraoperative Neuromonitoring of the Recurrent Laryngeal Nerve in Thyroid Surgery
Continuous intraoperative neuromonitoring (C-IONM) is increasingly used during thyroid surgery to detect early changes in recurrent laryngeal nerve function and reduce the risk of nerve injury. Current clinical practice recommends the use of fixed supramaximal stimulation currents; however, these recommendations are based on limited experimental evidence and may not account for individual variability between patients.
This retrospective observational cohort study aims to determine patient-specific supramaximal stimulation currents (SSC) during C-IONM and to evaluate whether individualized stimulation provides monitoring quality comparable to conventional fixed-current stimulation while potentially reducing unnecessary stimulation intensity. The study also investigates factors influencing electromyographic response amplitudes during surgery and assesses the safety of individualized stimulation parameters.
Read the detailed description
Continuous intraoperative neuromonitoring (C-IONM) of the vagus nerve is increasingly used during thyroid surgery to facilitate early recognition of progressive recurrent laryngeal nerve (RLN) injury. Current international recommendations advocate the use of a fixed supramaximal stimulation current, typically between 1 and 2 mA. However, these recommendations are based on limited experimental and clinical evidence and do not account for potential interindividual differences in nerve excitability.
The aim of this retrospective observational cohort study was to characterize the distribution of patient-specific supramaximal stimulation current (SSC) during C-IONM and to determine whether individualized SSC selection maintains monitoring performance compared with conventional fixed-current stimulation. Secondary objectives included evaluation of factors affecting electromyographic response amplitude and assessment of the safety of individualized stimulation.
The study included consecutive adult patients undergoing thyroid surgery with C-IONM at a tertiary endocrine surgery center. Patients operated before implementation of an updated stimulation protocol constituted the control cohort and underwent monitoring using a fixed stimulation current of 1.5 mA. After protocol implementation, SSC was individually determined for each vagus nerve at the beginning of the procedure by gradually increasing stimulation current until no further increase in electromyographic response amplitude was observed. Continuous monitoring was subsequently performed using the individualized SSC.
Neuromonitoring recordings were exported from the monitoring system, anonymized, and analyzed using dedicated Python software developed for this study. The software identified individual stimulation events, excluded incomplete or technically inadequate recordings, and extracted stimulation current and electromyographic amplitude for quantitative analysis. More than one million individual stimulation responses were evaluated.
The primary objective was to determine the distribution of individualized SSC values and compare monitoring performance between individualized and fixed-current stimulation. Secondary analyses evaluated changes in response amplitude during surgery, variability between right and left vagus nerves, factors influencing amplitude, and the occurrence of monitoring-related adverse events.
Statistical analyses included descriptive statistics, non-parametric comparisons, regression analysis, and multivariable modeling to identify independent predictors of electromyographic response amplitude.
- Conditions
- Thyroid Disease
- Being tested
- Continuous intraoperative neuromonitoring with fixed stimulation current, Continuous intraoperative neuromonitoring with individualized stimulation current
- Keywords
- Thyroid surgery, Thyroidectomy, Continuous intraoperative neuromonitoring, Supramaximal stimulation current, Recurrent laryngeal nerve
- Medical subject headings
- Thyroid Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous intraoperative neuromonitoring with fixed stimulation currentProcedure or surgery
Continuous vagus nerve stimulation during thyroid surgery using a fixed supramaximal stimulation current of 1.5 mA.
Continuous intraoperative neuromonitoring with individualized stimulation currentProcedure or surgery
Continuous vagus nerve stimulation during thyroid surgery using an individually determined supramaximal stimulation current established at the beginning of the procedure.
| Study group | Role | What they receive |
|---|---|---|
| Control cohort | Patients who underwent thyroid surgery with continuous intraoperative neuromonitoring (C-IONM) using a fixed vagus nerve stimulation current of 1.5 mA throughout the procedure. These patients were operated before implementation of the individualized stimulation protocol. Receives: Procedure: Continuous intraoperative neuromonitoring with fixed stimulation current | |
| Individualized SSC cohort | Patients who underwent thyroid surgery with continuous intraoperative neuromonitoring (C-IONM) using an individually determined supramaximal stimulation current (SSC). SSC was established at the beginning of the procedure for each vagus nerve and subsequently used throughout continuous monitoring. Receives: Procedure: Continuous intraoperative neuromonitoring with individualized stimulation current |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient-specific supramaximal stimulation current
Distribution of the individualized supramaximal stimulation current required to achieve maximal electromyographic response during continuous intraoperative neuromonitoring of the vagus nerve.
Measured: During surgery
Patient-specific supramaximal stimulation current (SSC)
Distribution of the individualized supramaximal stimulation current (SSC) required to achieve maximal electromyographic response during continuous intraoperative neuromonitoring of the vagus nerve.
Measured: During surgery (at the beginning of continuous intraoperative neuromonitoring)
Secondary outcomes (1)
Electromyographic response amplitude
Comparison of electromyographic response amplitudes between individualized and fixed stimulation current protocols during continuous intraoperative neuromonitoring.
Measured: During surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2026
- Study start18 Jun 2020
- Primary completion25 Jul 2024
- Study completion11 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid DiseaseStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 623 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Gdansk
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07710365
- Sponsor's protocol ID
- KB/202/2025
- Acronym
- CIONM-SSC
- Status last verified
- Jul 2026
- First submitted
- 13 Jul 2026
- Last updated
- 17 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the reported results will be available upon reasonable request to the corresponding author, subject to approval from the hospital administration and applicable ethical and institutional regulations.
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient-Specific Determination of Supramaximal Stimulation Current During Continuous Intraoperative Neuromonitoring of the Recurrent Laryngeal Nerve in Thyroid Surgery
- ClinicalTrials.gov ID
- NCT07710365
- Acronym / sponsor ID
- CIONM-SSC / KB/202/2025
- Conditions
- Thyroid Disease
- Keywords
- Thyroid surgery, Thyroidectomy, Continuous intraoperative neuromonitoring, Supramaximal stimulation current, Recurrent laryngeal nerve
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 623 participants (actual)
- Lead sponsor
- Medical University of GdanskUniversity, hospital or other
- Study start
- 18 Jun 2020 (actual)
- Primary completion
- 25 Jul 2024 (actual)
- Study completion
- 11 Feb 2025 (actual)
- First posted
- 17 Jul 2026 (actual)
- 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.
Continuous intraoperative neuromonitoring (C-IONM) is increasingly used during thyroid surgery to detect early changes in recurrent laryngeal nerve function and reduce the risk of nerve injury. Current clinical practice recommends the use of fixed supramaximal stimulation currents; however, these recommendations are based on limited experimental evidence and may not account for individual variability between patients.
This retrospective observational cohort study aims to determine patient-specific supramaximal stimulation currents (SSC) during C-IONM and to evaluate whether individualized stimulation provides monitoring quality comparable to conventional fixed-current stimulation while potentially reducing unnecessary stimulation intensity. The study also investigates factors influencing electromyographic response amplitudes during surgery and assesses the safety of individualized stimulation parameters.
Detailed description
Continuous intraoperative neuromonitoring (C-IONM) of the vagus nerve is increasingly used during thyroid surgery to facilitate early recognition of progressive recurrent laryngeal nerve (RLN) injury. Current international recommendations advocate the use of a fixed supramaximal stimulation current, typically between 1 and 2 mA. However, these recommendations are based on limited experimental and clinical evidence and do not account for potential interindividual differences in nerve excitability.
The aim of this retrospective observational cohort study was to characterize the distribution of patient-specific supramaximal stimulation current (SSC) during C-IONM and to determine whether individualized SSC selection maintains monitoring performance compared with conventional fixed-current stimulation. Secondary objectives included evaluation of factors affecting electromyographic response amplitude and assessment of the safety of individualized stimulation.
The study included consecutive adult patients undergoing thyroid surgery with C-IONM at a tertiary endocrine surgery center. Patients operated before implementation of an updated stimulation protocol constituted the control cohort and underwent monitoring using a fixed stimulation current of 1.5 mA. After protocol implementation, SSC was individually determined for each vagus nerve at the beginning of the procedure by gradually increasing stimulation current until no further increase in electromyographic response amplitude was observed. Continuous monitoring was subsequently performed using the individualized SSC.
Neuromonitoring recordings were exported from the monitoring system, anonymized, and analyzed using dedicated Python software developed for this study. The software identified individual stimulation events, excluded incomplete or technically inadequate recordings, and extracted stimulation current and electromyographic amplitude for quantitative analysis. More than one million individual stimulation responses were evaluated.
The primary objective was to determine the distribution of individualized SSC values and compare monitoring performance between individualized and fixed-current stimulation. Secondary analyses evaluated changes in response amplitude during surgery, variability between right and left vagus nerves, factors influencing amplitude, and the occurrence of monitoring-related adverse events.
Statistical analyses included descriptive statistics, non-parametric comparisons, regression analysis, and multivariable modeling to identify independent predictors of electromyographic response amplitude.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control cohort | – | Procedure: Continuous intraoperative neuromonitoring with fixed stimulation currentPatients who underwent thyroid surgery with continuous intraoperative neuromonitoring (C-IONM) using a fixed vagus nerve stimulation current of 1.5 mA throughout the procedure. These patients were operated before implementation of the individualized stimulation protocol. |
| Individualized SSC cohort | – | Procedure: Continuous intraoperative neuromonitoring with individualized stimulation currentPatients who underwent thyroid surgery with continuous intraoperative neuromonitoring (C-IONM) using an individually determined supramaximal stimulation current (SSC). SSC was established at the beginning of the procedure for each vagus nerve and subsequently used throughout continuous monitoring. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consisted of consecutive adult patients who underwent thyroid surgery with continuous intraoperative neuromonitoring (C-IONM) at the Department of Endocrine and General Surgery, Medical University of Gdańsk, Poland, between June 2020 and July 2024. Patients were identified retrospectively from the institutional thyroid surgery database and neuromonitoring records. Clinical and operative data were collected as part of routine clinical care. Participants were included consecutively during the study period.
Key inclusion criteria (4 listed)
- Adults aged 18 years or older.
- Patients undergoing thyroid surgery with continuous intraoperative neuromonitoring (C-IONM) of the vagus nerve.
- Availability of complete intraoperative neuromonitoring recordings suitable for analysis.
- Availability of complete clinical and operative data.
Key exclusion criteria (4 listed)
- Age younger than 18 years.
- Incomplete or technically inadequate neuromonitoring recordings.
- Loss of signal or recurrent laryngeal nerve palsy preventing reliable amplitude analysis.
- Missing or incomplete clinical data required for the study.
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 |
|---|---|---|
| Continuous intraoperative neuromonitoring with fixed stimulation currentContinuous vagus nerve stimulation during thyroid surgery using a fixed supramaximal stimulation current of 1.5 mA. | Procedure or surgery | Control cohort |
| Continuous intraoperative neuromonitoring with individualized stimulation currentContinuous vagus nerve stimulation during thyroid surgery using an individually determined supramaximal stimulation current established at the beginning of the procedure. | Procedure or surgery | Individualized SSC cohort |
Primary outcome
Patient-specific supramaximal stimulation current
Time frame: During surgery
Distribution of the individualized supramaximal stimulation current required to achieve maximal electromyographic response during continuous intraoperative neuromonitoring of the vagus nerve.
Patient-specific supramaximal stimulation current (SSC)
Time frame: During surgery (at the beginning of continuous intraoperative neuromonitoring)
Distribution of the individualized supramaximal stimulation current (SSC) required to achieve maximal electromyographic response during continuous intraoperative neuromonitoring of the vagus nerve.
1 secondary outcome
Electromyographic response amplitude
Time frame: During surgery
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 Jul 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the reported results will be available upon reasonable request to the corresponding author, subject to approval from the hospital administration and applicable ethical and institutional regulations.
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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?
An observational study of Thyroid Disease, run by Medical University of Gdansk at 1 site in Poland.
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 4 inclusion and 4 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 Jul 2026. 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 Poland. 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?
Patient-specific supramaximal stimulation current (time frame: During surgery). The study lists 2 primary outcomes in all. 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 Jul 2026.