Impedance Plethysmography Based Deep Vein Thrombosis Monitoring During Catheter-directed Thrombolysis
The purpose of this study is to collect data on blood circulation using a multi-frequency impedance plethysmography device developed in the ThrombUS+ project. Impedance plethysmography (IPG) is a non-invasive method that measures changes in blood volume using electrodes placed on the skin. The collected data will be used for device development, the improvement of diagnostic data analysis methods, and AI training.
A total of 40 participants will be recruited for this study, with 20 healthy volunteers in Tampere University and 20 patients undergoing thrombolytic therapy for DVT at Tampere University Hospital.
研究概览
地位
详细说明
This study aims to collect IPG data set from healthy volunteers and DVT patients using ThrombUS+ prototype device developed during the project and commercial IPG device as a reference. The data will be used to develop ThrombUS+ IPG device, its signal processing and analysis algorithms and to train ML models.
Objectives of the study are to
- Collect IPG data for developing signal processing, data analysis and ML algorithms for DVT detection and assessment.
- Evaluate the performance of the developed methods to gold standard references including angiography, ultrasound imaging and venous occlusion plethysmography.
- Investigate whether multi-frequency IPG measurement improves the performance of DVT detection compared to single frequency measurement and determine the optimal measurement frequency.
- Investigate and compare different interventions to cause changes in venous blood volume for DVT detection, such as venous occlusion by thigh cuff, active respiration and muscle activation.
Secondary objectives are
1) To investigate methods for simulating DVT and to compare the performance of these methods for DVT simulation.
研究类型
注册 (估计的)
联系人和位置
学习联系方式
- 姓名：Vehkaoja
- 电话号码：+358407393181
- 邮箱：antti.vehkaoja@tuni.fi
学习地点
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Tampere、芬兰
- 招聘中
- Tampere University Hospital
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接触：
- Oksala
- 电话号码：+3583311611
- 邮箱：niku.oksala@tuni.fi
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Tampere、芬兰
- 完全的
- Tampere University
-
-
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
取样方法
研究人群
描述
Inclusion Criteria for Patients group:
- Age: 18 or older;
- DVT detected on other lower limb;
- Suitable for CDT treatment;
- Ability to give informed consent;
- Volunteering for the study.
Exclusion Criteria for Patients group:
- Age under 18 years;
- Inability to give informed consent;
- Denial;
- Too injured skin in the measurement area
Inclusion Criteria for Healthy volunteers group:
- Age: 18 or older;
- Ability to give informed consent;
- Volunteering for the study
Exclusion Criteria for Healthy volunteers group:
- Diagnosed DVT in lower limbs;
- Age under 18 years;
- Inability to give informed consent;
- Denial;
- Too injured skin in the measurement area.
学习计划
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
健康志愿者
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IPG signal is measured with ThrombUS+ prototype device
其他名称：
In VOP measurement, a temporal blood restriction is caused by an occlusive cuff blocking venous outflow but allowing arterial inflow.
The cuff intervention causes a change in venous blood volume, and it can be measured by electrical impedance plethysmography (IPG).
其他名称：
The first exercise is the Valsalva maneuver, where the subject first inhales and then pushes out the breath while the larynx is closed.
In the second exercise, the subject inhales for approximately 10 seconds, holds the breath for approximately 5 seconds, and then breathes out.
Finally, the subject moves the ankles to contract calf muscles, and further to cause changes in venous blood volume.
The IPG signal is measured on both calves by ThrombUS+ prototype device during these exercises.
其他名称：
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Patients
DVT detected on other lower limb, undergoing catheter-directed thrombolysis
|
IPG signal is measured with ThrombUS+ prototype device
其他名称：
In VOP measurement, a temporal blood restriction is caused by an occlusive cuff blocking venous outflow but allowing arterial inflow.
The cuff intervention causes a change in venous blood volume, and it can be measured by electrical impedance plethysmography (IPG).
其他名称：
The first exercise is the Valsalva maneuver, where the subject first inhales and then pushes out the breath while the larynx is closed.
In the second exercise, the subject inhales for approximately 10 seconds, holds the breath for approximately 5 seconds, and then breathes out.
Finally, the subject moves the ankles to contract calf muscles, and further to cause changes in venous blood volume.
The IPG signal is measured on both calves by ThrombUS+ prototype device during these exercises.
其他名称：
|
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Impedance plethysmography (IPG) data during CDT treatment
大体时间：From enrollment to the end of the CDT treatment (up to 2 days)
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From enrollment to the end of the CDT treatment (up to 2 days)
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Impedance plethysmography (IPG) data from healthy volunteers
大体时间：From enrollment to the end of measurements (up to 2 hours)
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From enrollment to the end of measurements (up to 2 hours)
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
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
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