Endoscopy-Assisted Tracheal Intubation Versus Conventional Tracheal Intubation for Endoscopic Submucosal Dissection (ESD): A Prospective Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 132
- 试验地点
- 1
- 主要终点
- preoperative preparation time
研究概览
简要总结
This study plans to enroll 132 patients undergoing upper gastrointestinal endoscopic submucosal dissection (ESD). Patients will be randomly divided into a control group (conventional tracheal intubation) and an experimental group (endoscopy-assisted tracheal intubation). Patients meeting the inclusion criteria and not falling under the exclusion criteria will be invited to participate in the study. Upon providing voluntary consent, the research physician will arrange for the patient's inclusion in the study. After signing the informed consent form, the research physician will collect the patient's basic information, medical history, and other details, followed by timing the preoperative preparation period and evaluating postoperative discomfort
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing endoscopic submucosal dissection (ESD) at Ningbo University Affiliated First Hospital from December 2024 to December
- •Aged between 18 and 75 years.
- •Patients who voluntarily agree to participate in the study and sign the informed consent form.
排除标准
- •Individuals under 18 years of age.
- •Patients unwilling or unable to provide informed consent.
- •Patients with severe chronic cardiac or pulmonary disease, or those who have required hospitalization for coronary or cerebrovascular events or radiotherapy within the past 3 months.
- •Patients with severe abdominal symptoms such as severe pain, bloating, or nausea.
- •Patients with inadequate preoperative preparation.
- •Individuals requiring lifelong anticoagulant therapy, those with severe bleeding disorders, or those who have recently taken anticoagulant or antiplatelet medications.
- •Pregnant or breastfeeding individuals.
研究组 & 干预措施
Endoscopy-Assisted Tracheal Intubation
Tracheal Intubation Under Endoscopic Guidance
干预措施: Endoscopy-Assisted Tracheal Intubation (Other)
Traditional Tracheal Intubation
Tracheal Intubation Under Video Laryngoscopy
干预措施: Traditional Tracheal Intubation (Other)
结局指标
主要结局
preoperative preparation time
时间窗: 30 minutes
the time from Initiate Anesthesia Induction to Insert the Therapeutic Endoscope into the Oral Cavity
次要结局
- The time to view the vocal cords (TVVC)(10 minutes)
- The time to advance the tracheal tube into trachea (TATT)(10 minutes)