跳至主要内容
临床试验/CTRI/2023/05/052990
CTRI/2023/05/052990招募中不适用

Comparison of contactless continuous non-invasive blood pressure monitoring with invasive blood pressure monitoring: an observational study

Dr. Prakash K Dubey1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2023年6月15日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
100
试验地点
1
主要终点
To evaluate the Dozee contactless BP using the IBP as the gold standard for continuous BP monitoring

研究概览

简要总结

Continuous monitoring of vital signs occurs in intensive care units (ICUs) to detect developing instability and identify the need for intervention. However, outside ICU settings in step-down or ward units, there is a lack of monitoring and patients continue to be at high risk of cardiorespiratory compromise, which has both acute and long-term consequences. As a result, a major healthcare focus is on utilizing these hemodynamic signals to predict when such risks will occur and to provide timely intervention to maintain cardiovascular function and organ perfusion in order to avoid secondary injury. To that end real-time, continuous physiologic measurements of these hemodynamic signals are critical. Dozee uses the concept of ballistocardiography, a non-invasive technique for measuring micro-body vibrations arising from cardiac contractions. It has been validated for measuring heart rate (HR), respiration rate (RR), movement, and sleep. Contact accessories like SpO2 have been integrated. Through data analysis, it was noted that there is a pattern consistent with systolic BP changes. The current product has shown some correlation to cuff-based BP monitors and also to the IBP.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 75.00 Year(s)(—)
性别
All

入选标准

  • •1.Adult (>18 years old) ICU patient who already has an intra-arterial blood pressure measurement in place.
  • •2.Weight between 40kg-150kgs 3.Have been connected to ICU monitor for blood pressure measurements using both IBP and CBP 4.They/ legal representative are able and willing to provide written informed consent.

排除标准

  • •1.Weight below 40 kgs and above 150 kgs 2.Currently pregnant 3.Have any condition that could interfere with the subjects ability to tolerate continuous monitoring with IBP or periodic monitoring with CBP 4.Exhibit injuries, deformities, intravenous lines, or other abnormalities that, in the opinion of the investigator, may prevent proper cuff application or functioning 5.Level of agitation or non-compliance too high to enroll in opinion of PI 6.Needs the use of equipments whose operation can interfere with Dozee’s signal.

结局指标

主要结局

To evaluate the Dozee contactless BP using the IBP as the gold standard for continuous BP monitoring

时间窗: From time of admission in the ICU to 72 hours

次要结局

  • To compare the Dozee BP to cuff based CBP(From time of admission in the ICU to 72 hours)

研究者

发起方
Dr. Prakash K Dubey
申办方类型
Other [self]

研究点 (1)

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