Comparison of a Standalone, Continuous, Non-invasive Blood Pressure Monitor (cNIBP) to Radial Arterial Catheterization in Patients Undergoing Surgery.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Comparison of Diastolic Blood Pressure
研究概览
简要总结
To compare a noninvasive and continuous radial artery blood pressure measurements utilizing ViTrack (developed by Dynocardia) to the standard of care radial artery catheterization, in patients undergoing surgery or those who are being cared for in the intensive care unit
详细描述
The ViTrack is strapped over the radial artery at the wrist.The ViTrack blood pressure cuff will be utilized to obtain continuous blood pressure (BP) readings throughout the surgical procedure or intensive care unit. This will allow us to compare BP readings between the non-invasive ViTrack device and the standard of care invasive intra-arterial catheters readings. Data collection from both the ViTrack and arterial catheter occur in the opposite wrists.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
盲法说明
None, patients are their own control.
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients between the ages of 18 - 90 years age who are undergoing any surgery or in the intensive care unit and require intra-arterial catheterization for continuous BP measurement.
- •Patients having elective surgeries.
- •Patients having emergent surgeries, but only if research staff can have appropriate time to review study with patient and obtain signature on fact sheet prior to administration of medications that could affect coherency.
- •Patients who are able to review, verbalize understanding, and sign fact sheet. If patient has a health care proxy (HCP) or legal guardian, study will be reviewed, and signature of HCP or legal guardian will be obtained.
排除标准
- •Inability to obtain consent from the patient, HCP or legal guardian
- •Greater than 10% difference in BP measurements between both arms prior to surgery
- •Pregnant women
- •Prisoners
- •Inability to insert a radial artery catheter
- •Any other condition that would increase the risk of participation in the study in the opinion of the site Investigator
- •Upper extremity arteriovenous haemodialysis shunt
- •Upper extremity amputation
- •Surgical position/draping precludes access to the wrist.
- •Wrist distortion or pain from arthritis
- •Prior trauma or surgery at the radial artery monitoring site
结局指标
主要结局
Comparison of Diastolic Blood Pressure
时间窗: Up to 24 Hours
255 time points compared across continuous blood pressure (mmHg) As per the FDA standard ANSI/AAMI SP10:2008 or the newly adopted ISO 81060-3:2022 standard, the mean error should be \<5mmHg or \<6mmHg and the standard deviation should be \<8mmHg or \<10mmHg respectively.
Comparison of Systolic Blood Pressure
时间窗: Up to 24 Hours
255 time points compared across continuous blood pressure (mmHg) As per the FDA standard ANSI/AAMI SP10:2008 or the newly adopted ISO 81060-3:2022 standard, the mean error should be \<5mmHg or \<6mmHg and the standard deviation should be \<8mmHg or \<10mmHg respectively.
Comparison of Diastolic Blood Pressure
时间窗: Up to 24 Hours
255 time points compared across continuous blood pressure (mmHg) As per the FDA standard ANSI/AAMI SP10:2008 or the newly adopted ISO 81060-3:2022 standard, the mean error should be \<5mmHg or \<6mmHg and the standard deviation should be \<8mmHg or \<10mmHg respectively.
Comparison of Systolic Blood Pressure
时间窗: Up to 24 Hours
255 time points compared across continuous blood pressure (mmHg) As per the FDA standard ANSI/AAMI SP10:2008 or the newly adopted ISO 81060-3:2022 standard, the mean error should be \<5mmHg or \<6mmHg and the standard deviation should be \<8mmHg or \<10mmHg respectively.
次要结局
- Skin Irritation(Up to 72 hours)
研究者
James Aaron Scott
Assistant Professor of Anesthesiology & Perioperative Medicine
University of Massachusetts, Worcester