High Flow Nasal Oxygen During Conscious Sedation in the Cardiac Catheterisation Laboratory: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 129
- 试验地点
- 1
- 主要终点
- Peak transcutaneous carbon dioxide (TcCO2) concentration.
研究概览
简要总结
The primary objective of this study is to test the hypothesis that using high flow nasal oxygen improves ventilation during cardiac implantable electronic device procedures performed with conscious sedation. A randomized controlled trial design will be used with participants randomized in a 1:1 ratio to oxygen supplementation through a standard facemask or high flow nasal oxygen.
详细描述
High flow nasal oxygen (HFNO) is increasingly regarded as a promising technology for oxygen delivery in critical care and anesthetic management. Although promising, further high-quality studies examining the effects of using HFNO during procedural sedation are required to inform decision-making regarding implementation of this new technology into practice. The 2018 guidelines from the American Society of Anesthesiology stated that there is insufficient evidence regarding which methods of supplemental oxygen administration (e.g., nasal cannula, face mask, or specialized devices such as HFNO) are more effective. This trial will address this limitation in the evidence base specifically in regard to the efficacy of using HFNO during conscious sedation in the cardiac catheterisation laboratory.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Peak transcutaneous carbon dioxide (TcCO2) concentration.
时间窗: From the time between first sedative medication administration to the end of the procedure. Estimated duration of procedures is 30 minutes to 120 minutes.
Continuous measurements will be recorded using the Sentec Digital Monitoring with VSign 2 sensor.
次要结局
- Anesthesia Assistant rating of difficulty maintaining the patient's oxygenation status(To be completed as soon as possible after the end of the procedure (within about 5 minutes).)
- Anesthesia Assistant rating of difficulty using oxygen delivery device(To be completed as soon as possible after the end of the procedure (within about 5 minutes).)
- Costs associated with oxygen delivery(From the time between first sedative medication administration to the end of the procedure. Estimated duration of procedures is 30 minutes to 120 minutes.)
- Adverse sedation events(From the time between first sedative medication administration to the end of the procedure. Estimated duration of procedures is 30 minutes to 120 minutes.)
- Patient satisfaction with sedation: Iowa Satisfaction with Anesthesia Scale(After the participant has reached phase 2 post-anesthetic recovery. Estimated to be 30 minutes after procedure has finished.)
- Patient comfort of oxygen delivery(After the participant has reached phase 2 post-anesthetic recovery. Estimated to be 30 minutes after procedure has finished.)
- Mean transcutaneous carbon dioxide concentration(From the time between first sedative medication administration to the end of the procedure. Estimated duration of procedures is 30 minutes to 120 minutes.)
- Area under SpO2 90% oxygen desaturation curve(From the time between first sedative medication administration to the end of the procedure. Estimated duration of procedures is 30 minutes to 120 minutes.)
- Trajectory of transcutaneous carbon dioxide as a function of time(From the time between first sedative medication administration to the end of the procedure. Estimated duration of procedures is 30 minutes to 120 minutes.)
研究者
Aaron Conway
RBC Chair in Cardiovascular Nursing Research
University Health Network, Toronto