Continuous Blood Pressure Monitoring During Outpatient Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 188
- 试验地点
- 2
- 主要终点
- Percentage of adult patients undergoing elective noncardiac surgery in the outpatient setting who experience hypotension, defined as a mean arterial pressure (MAP) < 65 mmHg, for a total duration of at least 5 minutes.
研究概览
简要总结
A before and after interventional cohort study comparing intermittent blood pressure measurement using the oscillometric arm cuff to continuous noninvasive blood pressure (cNIBP) measurement using the VitaWave finger cuffs in subjects undergoing elective surgery in an outpatient setting.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Other
- 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
- •Signed informed consent
- •Age ≥ 18 years
- •American Society of Anesthesiologists (ASA) Physical Status ≥ 2
- •Scheduled for elective noncardiac surgery with intermittent arterial blood pressure monitoring using oscillometric arm cuff
排除标准
- •Patient who is known to be pregnant
- •Patient with existing or planned arterial pressure catheter
- •Patient in whom systolic arterial pressure differs by more than 20 mmHg between the right and left arms
- •Inability to place oscillometric cuff on the subject's upper extremity
- •Extreme contraction of the smooth muscle in the arteries and arterioles of the lower arm and hand, such as may be present in patients with Raynaud's disease
- •Finger or hand deformity that prevents proper placement of finger cuff by visual inspection
- •Inability to place finger cuffs due to subject anatomy, condition, or obstructive paraphernalia (such as false nails)
研究组 & 干预措施
Cohort 1 - Standard of Care
Study device data are blinded to the provider
干预措施: HemoSphere Vita Monitor with VitaWave or VitaWave Plus Finger Cuff Adult, and ForeSight Large Sensors (Device)
Cohort 2 - Standard of Care with cNIBP Monitoring
Study device continuous non-invasive blood pressure data are unblinded to the provider
干预措施: HemoSphere Vita Monitor with VitaWave or VitaWave Plus Finger Cuff Adult, and ForeSight Large Sensors (Device)
结局指标
主要结局
Percentage of adult patients undergoing elective noncardiac surgery in the outpatient setting who experience hypotension, defined as a mean arterial pressure (MAP) < 65 mmHg, for a total duration of at least 5 minutes.
时间窗: Through Study Completion, approximately 12 months
Percentage of adult patients undergoing elective noncardiac surgery in the outpatient setting who experience hypotension, defined as a MAP < 65 mmHg, for a total duration of at least 5 minutes.
时间窗: Through Study Completion, approximately 12 months
次要结局
未报告次要终点