Impedance Plethysmography Based Deep Vein Thrombosis Monitoring During Catheter-directed Thrombolysis

ConditionDeep Vein Thrombosis (DVT)

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorTampere University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Age: 18 or older;

DVT detected on other lower limb;

Suitable for CDT treatment;

Ability to give informed consent;

Disqualifiers

Age under 18 years;

Inability to give informed consent;

Denial;

Too injured skin in the measurement area

Trial population

Tampere

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Impedance plethysmography IPG
Device
IPG signal is measured with ThrombUS+ prototype device
Venous Occlusion Plethysmography VOP
Device
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).
Breathing and leg movement exercise
Other intervention
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.

Treatment groups

40 Participants

are divided into 2 treatment groups

Group A: Patients3 interventions

Group B: Healthy volunteers3 interventions

Trial outcomes

Primary outcomes

Impedance plethysmography (IPG) data during CDT treatment

Time frame

From enrollment to the end of the CDT treatment (up to 2 days)

Impedance plethysmography (IPG) data from healthy volunteers

Time frame

From enrollment to the end of measurements (up to 2 hours)

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tampere University

Lead sponsor

Tampere University Hospital

Collaborator

Source ClinicalTrials.gov

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