Deep Vein Thrombosis (DVT)
Conditions
Keywords
deep vein thrombosis, DVT
Brief summary
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.
Detailed description
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 1. Collect IPG data for developing signal processing, data analysis and ML algorithms for DVT detection and assessment. 2. Evaluate the performance of the developed methods to gold standard references including angiography, ultrasound imaging and venous occlusion plethysmography. 3. Investigate whether multi-frequency IPG measurement improves the performance of DVT detection compared to single frequency measurement and determine the optimal measurement frequency. 4. 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.
Interventions
DEVICEImpedance plethysmography IPG
IPG signal is measured with ThrombUS+ prototype device
DEVICEVenous Occlusion Plethysmography VOP
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).
OTHERBreathing and leg movement exercise
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.
Sponsors
Tampere University
Tampere University Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Impedance plethysmography (IPG) data during CDT treatment | From enrollment to the end of the CDT treatment (up to 2 days) |
| Impedance plethysmography (IPG) data from healthy volunteers | From enrollment to the end of measurements (up to 2 hours) |
Countries
Finland
Contacts
CONTACTVehkaoja
Outcome results
None listed