Capnographic Monitoring Decrease the Incidence of Hypoxia of the Elderly Patients Undergoing Gastrointestinal Endoscopy Procedure: a Randomized Multicenter Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,800
- 试验地点
- 3
- 主要终点
- The incidence of hypoxia
研究概览
简要总结
Hypoxia is the most common adverse event in gastrointestinal endoscopes sedated with propofol and sufentanil, especially in elderly people. The aim of this randomized study was to determine whether intervention based on additional capnographic monitoring reduces the incidence of hypoxia in gastrointestinal endoscopes procedures for elderly patients.
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
- Single (Participant)
入排标准
- 年龄范围
- 65 Years 至 79 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •65 ≤ Age <80
- •patients undergoing gastrointestinal endoscopes
- •patients signed informed consent form
- •ASA classification I-II
排除标准
- •Coagulation disorders or a tendency of nose bleeding
- •An episode/exacerbation of congestive heart failure (CHF) that requires a change in medication, diet or hospitalization from any cause in the last 6 months
- •Severe aortic stenosis or mitral stenosis
- •Cardiac surgery involving thoracotomy (e.g., coronary artery bypass graft (CABG), valve replacement surgery) in the last 6 months
- •Acute myocardial infarction in the last 6 months
- •Acute arrhythmia (including any tachycardia - or bradycardia) with the fluid of hemodynamics instability
- •Diagnosed chronic obstructive pulmonary disease or current other acute or chronic lung disease requiring supplemental chronic or intermittent oxygen therapy)
- •Pre-existing bradycardia (heart rate < 50 / min), or hypoxia (SaO2< 90 % )
- •Need supplemental oxygen because of pre-existing diseases
- •Emergency procedure or surgery
- •Multiple trauma
- •Upper respiratory tract infection
- •Allergy to propofol or tape and adhesives
研究组 & 干预措施
Capnographic monitoring group
In this group, in addition to the standard monitoring including observation, pulse oxygen saturation, non-invasive blood pressure, electrocardiogram in selected patients, the capnographic is also monitored. The capnographic data of the patients are available for additional noninvasive assessment of ventilation.
干预措施: Capnography monitoring (Device)
Capnographic monitoring group
In this group, in addition to the standard monitoring including observation, pulse oxygen saturation, non-invasive blood pressure, electrocardiogram in selected patients, the capnographic is also monitored. The capnographic data of the patients are available for additional noninvasive assessment of ventilation.
干预措施: Standard monitoring (Device)
Standard monitoring group
In this group, standard monitoring including observation, pulse oxygen saturation, non-invasive blood pressure, electrocardiogram in selected patients. Capnographic data are not visible by closing the CO2 sampling line till the endoscopy end.
干预措施: Standard monitoring (Device)
结局指标
主要结局
The incidence of hypoxia
时间窗: Patients will be followed for the duration of hospital stay, an expected average of 2 hours
(75% ≤ SpO2 \< 90% for \<60 s)
次要结局
- The incidence of other adverse events(Patients will be followed for the duration of hospital stay, an expected average about 2 hours)
- The incidence of sub-clinical respiratory depression(Patients will be followed for the duration of hospital stay, an expected average about 2 hours)
- The incidence of capnography curve decreased by half or more than the baseline and even disappeared without hypoxia(Patients will be followed for the duration of hospital stay, an expected average about 2 hours)
- The incidence of severe hypoxia(Patients will be followed for the duration of hospital stay, an expected average about 2 hours)
研究者
diansan su
Vice Chair of the Department of Anesthesiology
RenJi Hospital