Continuous BP Monitoring During Sedation for Endoscopy
Continuous Noninvasive Blood Pressure Monitoring During Sedation for High-Risk Patients Undergoing Gastrointestinal Endoscopy
This is a single-site observational, before/after cohort study comparing intermittent blood pressure measurement using to continuous noninvasive blood pressure measurement. The study is designed to determine the impact of the use of continuous noninvasive blood pressure monitoring on the incidence of hypotension in high-risk patients undergoing sedation for upper or lower endoscopic procedures.
研究概览
地位
详细说明
This is a single-site observational, before/after cohort study comparing intermittent blood pressure measurement using an oscillometric arm cuff to continuous noninvasive blood pressure measurement on the incidence of hypotension in high-risk patients undergoing sedation for upper or lower endoscopic procedures.
The primary aim is to determine the impact of the use of continuous noninvasive blood pressure monitoring on the incidence of hypotension. The secondary aims are to evaluate the impact of continuous blood pressure monitoring on total IV fluid administered, total vasopressor administered, intra-operative depth of sedation, post-operative nausea and vomiting (PONV), and the time to discharge readiness.
研究类型
注册 (估计的)
联系人和位置
学习联系方式
- 姓名：Neal Fleming, MD, PhD
- 电话号码：916 734-5028
- 邮箱：nwfleming@health.ucdavis.edu
研究联系人备份
- 姓名：David Asseff, MD
- 电话号码：916 734-5028
- 邮箱：dasseff@healt.ucdavis.edu
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
High-Risk Patients Undergoing Gastrointestinal Endoscopy
描述
Inclusion Criteria:
- Age ≥ 50 years
- American Society of Anesthesiologists (ASA) Physical Status ≥ 3
- Scheduled for upper or lower endoscopic procedure with planned propofol administration
- Planned oscillometric blood pressure monitoring using arm cuff without an arterial pressure catheter.
Exclusion Criteria:
- Age <50 years
- ASA Physical Status 1 or 2
- Patients known to be pregnant
- Patients with an existing arterial pressure catheter
- Patients on mechanical circulatory support
- Patients with planned intubation for procedure
- Patients with a difference in systolic blood pressure measurement between right and left upper extremities > 10 mmHg
- Patients with extreme contraction of the smooth muscle in the arteries and arterioles of the arm and hand, such as may be present with Raynaud's disease
- Patients with an inability to place the noninvasive finger cuffs due to anatomy, skin condition, or obstructive paraphernalia (such as false nails)
学习计划
研究是如何设计的？
设计细节
- 观测模型：CASE_CONTROL
- 时间观点：PROSPECTIVE
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
High-Risk Patients Undergoing Gastrointestinal Endoscopy
Patients scheduled for elective endoscopic procedures |
continuous noninvasive blood pressure monitoring |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
incidence of hypotension
大体时间：during procedure and post-procedure recovery period
|
Mean Arterial Pressure (MAP) < 65 mmHg for a total duration ≥ 5 minutes |
during procedure and post-procedure recovery period
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
total IV fluid administered
大体时间：during procedure and post-procedure recovery period
|
Volume in ml/kg/hr |
during procedure and post-procedure recovery period
|
|
total vasopressor administered
大体时间：during procedure and post-procedure recovery period
|
Total doses in mg/kg |
during procedure and post-procedure recovery period
|
|
intra-operative depth of sedation
大体时间：during procedure and post-procedure recovery period
|
Patient State Index (PSI), mean, min, max |
during procedure and post-procedure recovery period
|
|
post-operative nausea and vomiting
大体时间：during procedure and post-procedure recovery period
|
Incidence requiring treatment |
during procedure and post-procedure recovery period
|
|
time to discharge readiness
大体时间：during procedure and post-procedure recovery period
|
Time from Post-Anesthesia Care Unit (PACU) admission to Aldrete Score=10 |
during procedure and post-procedure recovery period
|
合作者和调查者
调查人员
- 研究主任：Neal Fleming, MD, PhD、University of California, Davis
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- 2465371
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
Confidentiality requirements require review
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
在美国制造并从美国出口的产品
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.