COMBO Endoscopy Oropharyngeal Airway in Sedated Fiberoptic Bronchoscopy for Patients: A Simon Two-Stage Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- The incidence of hypoxia（75% ≤ SpO2 < 90% for <60 s）
研究概览
简要总结
Hypoxia represents the prevailing adverse occurrence during the sedation of patients undergoing fiberoptic bronchoscopy with propofol. A recent innovation in this domain is the COMBO Endoscopy Oropharyngeal Airway-a multifaceted device that encompasses capnography monitoring, bite block , oxygenation support, and oropharyngeal airway management. This device has been purposefully designed to cater to the unique requirements of endoscopic procedures. The principal objective of our randomized study is to assess the efficacy and safety of the COMBO Endoscopy Oropharyngeal Airway reduce the incidence of hypoxia on patients undergoing fiberoptic bronchoscopy under propofol sedation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18≤ Age ≤70.·Patients undergoing fiberoptic bronchoscopy.
- •Patients have signed the informed consent form.
- •The ASA classification ranges from I to II.
- •The estimated duration of the procedure does not exceed 45 minutes.
排除标准
- •Patients with contraindications to oropharyngeal airway ventilation, such as coagulation disorders, predisposition to oral/nasal bleeding, mucosal damage, or anatomical obstructions hindering oropharyngeal airway placement.
- •Patients diagnosed with acute exacerbation of chronic obstructive pulmonary disease (COPD) or those currently suffering from other acute/chronic pulmonary conditions requiring long-term or intermittent oxygen therapy.
- •Patients with preoperative SpO₂ < 95% while breathing air.
- •Patients with BMI < 18.5 or BMI >
- •Patients with upper respiratory tract infections (oral, nasal, or pharyngeal).
- •Patients at risk of aspiration.
- •Patients with fever (core temperature > 37.5°C).
- •Patients with severe cardiac insufficiency (< 4 METs).
- •Patients with severe renal insufficiency requiring preoperative dialysis.
- •Patients with a confirmed diagnosis of hepatic insufficiency.
- •Patients with increased intracranial pressure.
- •Patients with hypersensitivity to sedatives like propofol or medical equipment such as adhesive tape.
- •Patients with a history of drug abuse and/or alcoholism within the two years preceding the commencement of the screening period (defined as drinking more than three standard alcoholic beverages daily, roughly equivalent to 10g of alcohol or 50g of Chinese Baijiu).
- •Patients with a history of mental and neurological disorders, including but not limited to depression, severe central nervous system depression, Parkinson's disease, basal ganglia lesions, schizophrenia, epilepsy, Alzheimer's disease, and myasthenia gravis.
- •Patients currently participating in other clinical trials.
- •Patients deemed ineligible for participation in this clinical trial by the researchers.
研究组 & 干预措施
the COMBO Endoscopy Oropharyngeal Airway Group
In this group, patients use the COMBO Endoscopy Oropharyngeal Airway for oxygenation.
干预措施: the COMBO Endoscopy Oropharyngeal Airway (Device)
结局指标
主要结局
The incidence of hypoxia（75% ≤ SpO2 < 90% for <60 s）
时间窗: Patients are continuously monitored from the beginning of anesthesia induction until exiting the PACU (Post-Anesthesia Care Unit).
次要结局
- The incidence of sub-clinical respiratory depression（90% ≤ SpO2 < 95%）(Patients are continuously monitored from the beginning of anesthesia induction until exiting the PACU (Post-Anesthesia Care Unit).)
- The incidence of severe hypoxia（SpO2 < 75% or 75% ≤ SpO2 < 90% for ≥60 s）(Patients are continuously monitored from the beginning of anesthesia induction until exiting the PACU (Post-Anesthesia Care Unit).)
研究者
Diansan Su
chair of Anesthesiology Department
First Affiliated Hospital of Zhejiang University