Comparison of safety and efficacy of innovative thyroid cartilage needle electrodes with standard neural integrity monitor endotracheal tube for intra-operative nerve monitoring during thyroidectomy surgeries- a randomized clinical trial.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 1. Efficacy & Safety profile, including intraoperative complications and postoperative adverse events.
研究概览
简要总结
This randomized clinical trial will be conducted at a tertiary care hospital in central India, enrolling 60 patients with thyroid swelling who meet eligibility criteria. Participants will be randomized by SNOSE technique into two groups- intraoperative neuromonitoring using either thyroid cartilage needle electrodes or the standard neural integrity monitor endotracheal tube. Baseline demographics, intraoperative parameters, complications, and postoperative outcomes will be systematically recorded using a predesigned proforma, with follow-up at predetermined intervals. Statistical analysis will include t-tests, chi-square tests, and ANOVA with 95 percentage confidence interval, 90 percentage power, and alpha =0.05. Safety, efficacy, and cost-effectiveness of the two techniques will be evaluated, with monitoring and reporting of adverse events. Ethical approval obtained from the Institutional Ethics Committee, and informed consent will be secured from all participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients scheduled to undergo thyroidectomy surgery.
- •Adults aged 18 years and above.
- •Patients willing to participate in the randomized clinical trial and provide informed consent.
- •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.
- •Patients without significant abnormalities in vocal cord function or laryngeal anatomy that would preclude the use of IONM electrodes.
排除标准
- •Patients with contraindications to thyroidectomy surgery.
- •Patients with pre-existing vocal cord dysfunction or laryngeal pathology.
- •Individuals enrolled in other clinical trials concurrently.
- •Pregnant women or those planning to become pregnant during the study period.
- •Patients with significant comorbidities that may affect surgical outcomes or intraoperative neuromonitoring, such as severe cardiopulmonary disease or neurological disorders.
结局指标
主要结局
1. Efficacy & Safety profile, including intraoperative complications and postoperative adverse events.
时间窗: Intraoperatively and at 3 months and 6 months
次要结局
- 1. Incidence of recurrent laryngeal nerve (RLN) injury.(2. Signal quality & reliability comparison.)
研究者
Dr Rohit Bhondekar
AIIMS Nagpur