Position Intervention to Reduce Hypoxemia in Sedation Patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1,752
- 试验地点
- 1
- 主要终点
- The lowest SpO2
研究概览
简要总结
Hypoxemia was defined as an SpO2 of < 90% for any duration. Failure to treat promptly can lead to hypoxemia, which may increase the risks of arrhythmia, nausea and vomiting, and cognitive dysfunction. Studies have shown that body position has a direct impact on respiratory function. In special environments, including outside the operating room where emergency airway management for critically ill and injured patients is needed, or in areas with limited medical resources like remote areas, adopting simple interventions by changing position to maintain patients' respiratory function can be more economical, convenient and safe.
详细描述
Hypoxemia was defined as an SpO2 of < 90% for any duration. Failure to treat promptly can lead to hypoxemia, which may increase the risks of arrhythmia, nausea and vomiting, and cognitive dysfunction. Studies have shown that body position has a direct impact on respiratory function. In special environments, including outside the operating room where emergency airway management for critically ill and injured patients is needed, or in areas with limited medical resources like remote areas, adopting simple positional interventions to maintain patients' respiratory function can be more economical, convenient and safe. This study aims to conduct a prospective, multicenter, randomized controlled trial to observe the level of patients' oxygen saturation and the occurrence of hypoxemia under different body positions (supine and lateral positions), and its impact on prognosis, providing reliable evidence-based medical evidence for the prevention and treatment of complications in patients requiring airway management.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with 18 years or older
- •Without obvious cardiovascular or pulmonary dysfunction
- •Scheduled to undergo procedure or surgery with sedation
- •Signed the informed consent form
排除标准
- •Preexisting bradycardia (heart rate <50 beats/min), hypotension (systolic blood pressure < 80mmHg), or hypoxemia (SpO2 < 90%);
- •Requiring supplemental chronic or intermittent oxygen therapy because of preexisting diseases
- •Preexisting diseases which unable to tolerate reduced SpO2 or Partial pressure of carbon dioxide in artery (PaCO2) diseases, such as severe cardiovascular and cerebrovascular diseases, intracranial hypertension or severe lung diseases;
- •Coagulation disorders or a tendency of nose bleeding;
- •Patients whose body position cannot be altered;
- •Participated in other intervention clinical studies in the past 3 months;
- •Other conditions deemed unsuitable for inclusion by the researcher;
- •Patients and guardians refused to participate in this trial.
结局指标
主要结局
The lowest SpO2
时间窗: During procedure
The lowest SpO2 during sedation and procedures
Use of airway interventions
时间窗: During procedure
Use of airway interventions including increased inhaled O2, ventilated mask and endotracheal intubation
次要结局
- The onset of respiratory adverse events(During procedure)
- The degree of operator satisfaction(During procedure)
- The onset of when SpO2 dropped below 80%(During procedure)
- The onset of when SpO2 dropped below 70%(During procedure)
- The onset of gastrointestinal adverse events(During procedure)
- The onset of circulatory adverse events(During procedure)
研究者
xiangming fang
Director, Head of Anesthesiology and Critical Care, Principal Investigator, Professor
First Affiliated Hospital of Zhejiang University