The Effect of Hyperoxia on Cardiac Output in Patients Undergoing Procedural Sedation in the Emergency Department.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- The change in cardiac output (L/min) after respectively 15L/min and flush rate preoxygenation in respect to baseline
研究概览
简要总结
Rational: Preoxygenation is a standard procedure before (deep) sedation in the ED. However, there is literature suggesting that too much oxygen can be harmful. One potential detrimental effect is a decrease in cardiac output due to coronary vasoconstriction. So far, it is unknown if this effect is rate dependent and if it also occurs after only a short period of hyperoxia, as patients experience during procedural sedation pre-oxygenation.
Objective: To investigate if hyperoxia has a negative effect on Cardiac index (CI) in patients undergoing procedural sedation in the ED.
详细描述
Methods: In patients needing sedation for a painful condition, non-invasive measurements of CI, stroke volume and total peripheral resistance are performed using the Clearsight non-invasive cardiac output monitoring system.. Measurements will be taken at baseline, after 1,2 and 5 minutes of 15L O2/min, and then after another 2 and 5 minutes of flush rate oxygen and during the subsequent sedation.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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 presenting in the ED of the Medical Center Leeuwarden (MCL) who have a painful condition for which procedural sedation is required.
排除标准
- •- Cardiogenic shock (SBP<90 mmHg)
- •Procedural sedation for cardioversion
- •Pregnancy
- •General contra-indications for the procedural sedation according to local sedation protocol of the MCL.
- •Hypoxia (sat <90% or pO2 <8)) despite oxygen suppletion
- •Age < 18 years
- •Non-invasive ventilation (NIV) or intubation
- •No informed consent
- •Use of bleomycin
- •COPD GOLD III of IV
- •COPD GOLD I of II with hypercapnia (PCO2 > 6,4 kPa)
- •Patients in whom no reliable signal for Clearsight measurement can be obtained
结局指标
主要结局
The change in cardiac output (L/min) after respectively 15L/min and flush rate preoxygenation in respect to baseline
时间窗: at baseline, at 1,2,5 (15L),7 and 10 minutes (flush o2)
Cardiac output is measured by Clearsight non invasive hemodynamic monitoring system; 3 baseline measurements are done separated by one minute intervals; subsequently 15L/min O2 is started. After 1,2 and 5 minutes, measurements are repeated. After 5 minutes, flush rate O2 is started. After 2 and 5 minutes, measurements are repeated.
次要结局
- The change in heart rate (BPM) after respectively 15L/min and flush rate preoxygenation in respect to baseline(at baseline, at 1,2,5, (15L o2) and 7, 10 minutes (flush o2))
- the change in systolic blood pressure (mmHg) after respectively 15L/min and flush rate preoxygenation in respect to baseline(at baseline, at 1,2,5 (15L o2) and 7, 10 minutes (flush o2))
- The change in stroke volume (ml) after respectively 15L/min and flush rate preoxygenation in respect to baseline(at baseline, at 1,2,5 (15L o2) and 7, 10 minutes (flush o2))
- the change in total peripheral vascular resistance after respectively 15L/min and flush rate preoxygenation in respect to baseline(at baseline, at 1,2,5 (15L o2) and 7,10 minutes (flush o2))
- The relation of the difference in CI with the occurrence of of haemodynamic sedation events(at baseline, at 1,2,5 (15L o2) ,7 and 10 minutes (flush o2))