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.
연구 개요
상태
상세 설명
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.
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Vehkaoja
- 전화번호: +358407393181
- 이메일: antti.vehkaoja@tuni.fi
연구 장소
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Tampere, 핀란드
- 모병
- Tampere University Hospital
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연락하다:
- Oksala
- 전화번호: +3583311611
- 이메일: niku.oksala@tuni.fi
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Tampere, 핀란드
- 완전한
- Tampere University
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
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건강한 자원봉사자
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IPG signal is measured with ThrombUS+ prototype device
다른 이름들:
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).
다른 이름들:
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.
다른 이름들:
|
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Patients
DVT detected on other lower limb, undergoing catheter-directed thrombolysis
|
IPG signal is measured with ThrombUS+ prototype device
다른 이름들:
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).
다른 이름들:
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.
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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Impedance plethysmography (IPG) data during CDT treatment
기간: 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
기간: 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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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- ThrombUS+B4
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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