Health Condition 1: O- Medical and Surgical
Conditions
Interventions
Intervention1: Thyroid Cartilage Needle Electrodes: These are novel electrodes which will be placed onto thyroid cartilage for intra-operative nerve monitoring
Control Intervention1: Neural Integrity
Sponsors
Dr Rohit Bhondekar
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients scheduled to undergo thyroidectomy surgery. 2. Adults aged 18 years and above. 3. Patients willing to participate in the randomized clinical trial and provide informed consent. 4. Individuals with a willingness to engage in postoperative follow-up assessments to evaluate the long-term efficacy and safety of the novel electrode techniques compared to standard approaches. 5. Patients without significant abnormalities in vocal cord function or laryngeal anatomy that would preclude the use of IONM electrodes.
Exclusion criteria
Exclusion criteria: 1. Patients with contraindications to thyroidectomy surgery. 2. Patients with pre-existing vocal cord dysfunction or laryngeal pathology. 3. Individuals enrolled in other clinical trials concurrently. 4. Pregnant women or those planning to become pregnant during the study period. s. Patients with significant comorbidities that may affect surgical outcomes or intraoperative neuromonitoring, such as severe cardiopulmonary disease or neurological disorders. 6. Individuals enrolled in other clinical trials concurrently.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Efficacy & Safety profile, including intraoperative complications and postoperative adverse events. Timepoint: Intraoperatively and at 3 months and 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Incidence of recurrent laryngeal nerve (RLN) injury. 2. Signal quality & reliability comparison. 3. Patient-reported outcomes related to voice quality, swallowing function, & overall satisfaction. Timepoint: At baseline, 3 & 6 months | — |
Countries
India
Contacts
Public ContactDr Rohit Bhondekar
AIIMS Nagpur
Outcome results
None listed