clinical evaluation of a 3 in 1 intraoperative protective device for endotracheal tube stabilisation for patients undergoing general anaesthesia during surgical procedures A single arm comparative analytical study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Endotracheal tube stability, assessed by the presence or absence of tube displacement during surgery.
研究概览
简要总结
This is a prospective interventional single-arm clinical study conducted to evaluate a novel three-in-one intraoperative protective device consisting of an endotracheal tube holder with an integrated bite block and protective eye piece. All participants will receive the novel device during elective surgical procedures under general anesthesia. The primary outcome is endotracheal tube stability during surgery. Secondary outcomes include incidence of dental, lip, or oral injury, bite-related tube obstruction, ocular complications, time taken for device application, and anesthesiologist satisfaction. Outcomes will be assessed at baseline before induction, intraoperatively, at the end of surgery, and within twenty-four hours postoperatively. The study aims to assess the safety, feasibility, and effectiveness of the novel device in a single group of patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
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 undergoing elective surgery under general anesthesia requiring endotracheal intubation, ASA physical status I–III, who provide written informed consent.
排除标准
- •Anticipated difficult airway Emergency surgeries Facial or oral pathology interfering with device placement Pre-existing ocular injury.
结局指标
主要结局
Endotracheal tube stability, assessed by the presence or absence of tube displacement during surgery.
时间窗: intra-operative for tube stability | and at the time of extubation
次要结局
- Incidence of dental, lip, or oral injury(Incidence of bite-related tube obstruction)
研究者
Nancy sharma
saveetha institute of medical and technical sciences