NCT06554678进行中（未招募）不适用
THRIVE Improves Early Postoperative Atelectasis in Long-Time Non-Tracheal Intubation Anesthesia for Gastrointestinal Endoscopy: a Clinical Study
Northern Jiangsu People's Hospital1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2024年2月18日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Incidence of atelectasis
研究概览
简要总结
This study aims to explore the clinical effect of THRIVE in improving early postoperative atelectasis in patients undergoing long-term non-intubated anesthesia gastrointestinal endoscopy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Investigator)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Multiple polyps resection, ESD(Endoscopic Submucosal Dissection) , EMR(Endoscopic Mucosal Resection), enteroscopy and other gastrointestinal endoscopic diagnosis and treatment were performed
- •The duration of anesthesia is more than 30 minutes, that is, from induction to withdrawal of anesthesia
- •ASA(American Society of Anesthesiologists) ≤ II 4.18kg/m2<BMI<30 kg/m2
- •5.Informed consent, voluntary participation in the experiment, and signed by the subject informed consent
排除标准
- •ASA classification ≥ III;
- •History of previous lung or nasal surgery;
- •History of chronic obstructive pulmonary disease (COPD) or restrictive lung disease;
- •History of obstructive sleep apnea syndrome;
- •History of upper airway obstruction;
- •History of head and neck radiation therapy;
- •Significant nasal septum deviation;
- •Active infection (defined as a white blood cell count >10*10^9 or a body temperature >38°C);
- •Gastrointestinal perforation;
- •Combined use of other anesthetic methods or inhalation anesthetics outside of non-intubated intravenous anesthesia;
- •Concurrent other medical procedures besides the prescribed gastrointestinal endoscopic procedures, such as ERCP(Endoscopic Retrograde Cholangiopancreatography);
- •Severe communication disorders due to conditions like severe hearing impairment or dementia;
- •Disagreement with participation in the study.
结局指标
主要结局
Incidence of atelectasis
时间窗: Early postoperative period
Lung ultrasound examination was performed before anesthesia induction (T1) and immediately after surgery (T2), and patients' modified lung ultrasound score (LUSS) was recorded.
次要结局
- Mean blood pressure (MBP)(Baseline，during surgery and arrived at PACU)
- Adverse Events (AEs) Within 7 Days Post-Operatively(Within 7 days after surgery)
- Diaphragm movement(Before anesthesia induction (T1) and immediately after surgery (T2))
- Heart rate (HR)(Baseline，during surgery and arrived at PACU)
- Pulse oxygen saturation (SpO2)(Baseline，during surgery and arrived at PACU)
- Patient satisfaction levels(After the patient is awake)
- Endoscopist satisfaction levels(After the surgery)
- Adverse Events (AEs) During Surgery and PACU(During surgery and PACU)
- PACU Stay Duration(The time from entering PACU to improving Aldrete score ≥9)
- Length of Hospital Stay(The time from admission to discharge)
- Dosage of propofol(During surgery)
- Dosage of remifentanil(During surgery)
研究者
Ju Gao
Study Director
Northern Jiangsu People's Hospital
研究点 (1)
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