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A study to evaluate the feasibility & accuracy of using trans-thyroid cartilage (TC) electrodes for recurrent laryngeal nerve monitoring during thyroid surgery

A pilot study to evaluate the feasibility & accuracy of using trans-thyroid cartilage (TC) electrodes for recurrent laryngeal nerve monitoring during thyroid surgery - IONM TRANS

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/08/044559
Enrollment
30
Registered
2022-08-01
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C73- Malignant neoplasm of thyroid gland

Interventions

Intervention1: Trans thyroid cartilage electrodes(TC Electrodes): TC electrodes will be used during surgery to record the nerve potentials and status of the RLN Control Intervention1: Endotracheal tub

Sponsors

Tata Memorial Centre
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients for thyroid /parathyroid/ airway surgery where RLN is at risk. 2. Planned for intraoperative neural monitoring using ET IONM as per the treating physicianââ?¬•s decision or patient preference. 3. Age >18 years 4. Willing to give valid informed consent for the study

Exclusion criteria

Exclusion criteria: 1. Preoperative vocal cord palsy on the side of surgery. 2. Patient not willing to give informed consent

Design outcomes

Primary

MeasureTime frame
1. To determine the accuracy of TC electrodes for predicting post operative vocal cord status during thyroid surgery. 2. To determine the mean EMG amplitudes for the signals at various phases of the surgery as compared to the ET IONMTimepoint: Documentation of vocal cord status - post surgery before discharge from hospital

Secondary

MeasureTime frame
1. To determine the cost effectiveness of using trans thyroid cartilage electrode as compared to endotracheal tube based RLN monitoring. 2. To determine time required for set up, any complications/limitations related to the use of this techniqueTimepoint: at completion of sample size i.e 30 patients

Countries

India

Contacts

Public ContactDR VIDISHA VIPIN TULJAPURKAR

Tata Memorial Centre

vidishavt@yahoo.com912224177187

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026