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Идёт набор NCT07665320

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

— Наблюдательное Deep Vein Thrombosis (DVT)

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Impedance plethysmography IPG, Venous Occlusion Plethysmography VOP, Breathing and leg movement exercise.
Кому может быть актуально
Состояния в реестре: Deep Vein Thrombosis (DVT). Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Финляндия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

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.

Подробное описание

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.

Вмешательства

  • Устройство Impedance plethysmography IPG
    IPG signal is measured with ThrombUS+ prototype device
  • Устройство Venous 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).
  • Другое Breathing 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.

Первичные конечные точки

  • Impedance plethysmography (IPG) data during CDT treatment [Срок оценки: From enrollment to the end of the CDT treatment (up to 2 days)]
  • Impedance plethysmography (IPG) data from healthy volunteers [Срок оценки: From enrollment to the end of measurements (up to 2 hours)]

Критерии участия

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Финляндия · 2 центра
  • Tampere University Hospital — Tampere
  • Tampere University — Tampere

Идентификаторы

NCT: NCT07665320 · ThrombUS+B4

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗