A study to evaluate the feasibility & accuracy of using trans-thyroidcartilage (TC) electrodes for recurrent laryngeal nerve monitoring during thyroidsurgery
Not Applicable
- Conditions
- Health Condition 1: C73- Malignant neoplasm of thyroid gland
- Registration Number
- CTRI/2022/08/044559
- Lead Sponsor
- Tata Memorial Centre
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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
1. Preoperative vocal cord palsy on the side of surgery.
2. Patient not willing to give informed consent
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. To determine the accuracy of TC electrodes for predicting post operative vocal cord status during <br/ ><br>thyroid surgery. <br/ ><br>2. To determine the mean EMG amplitudes for the signals at various phases of the surgery as compared <br/ ><br>to the ET IONMTimepoint: Documentation of vocal cord status - post surgery before discharge from hospital
- Secondary Outcome Measures
Name Time Method 1. To determine the cost effectiveness of using trans thyroid cartilage electrode as compared to <br/ ><br>endotracheal tube based RLN monitoring. <br/ ><br>2. To determine time required for set up, any complications/limitations related to the use of this <br/ ><br>techniqueTimepoint: at completion of sample size i.e 30 patients