Impedance Plethysmography Based Deep Vein Thrombosis Monitoring During Catheter-directed Thrombolysis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Impedance plethysmography (IPG) data during CDT treatment
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •for Patients group:
- •Age under 18 years;
- •Inability to give informed consent;
- •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;
- •Too injured skin in the measurement area.
研究组 & 干预措施
Patients
DVT detected on other lower limb, undergoing catheter-directed thrombolysis
干预措施: Impedance plethysmography IPG (Device)
Patients
DVT detected on other lower limb, undergoing catheter-directed thrombolysis
干预措施: Venous Occlusion Plethysmography VOP (Device)
Patients
DVT detected on other lower limb, undergoing catheter-directed thrombolysis
干预措施: Breathing and leg movement exercise (Other)
Healthy volunteers
Healthy volunteers
干预措施: Impedance plethysmography IPG (Device)
Healthy volunteers
Healthy volunteers
干预措施: Venous Occlusion Plethysmography VOP (Device)
Healthy volunteers
Healthy volunteers
干预措施: Breathing and leg movement exercise (Other)
结局指标
主要结局
Impedance plethysmography (IPG) data during CDT treatment
时间窗: From enrollment to the end of the CDT treatment (up to 2 days)
Impedance plethysmography (IPG) data from healthy volunteers
时间窗: From enrollment to the end of measurements (up to 2 hours)
次要结局
未报告次要终点
研究者
Antti Vehkaoja
Professor
Tampere University