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.
調査の概要
状態
詳細な説明
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.
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Vehkaoja
- 電話番号：+358407393181
- メール：antti.vehkaoja@tuni.fi
研究場所
-
-
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Tampere、フィンランド
- 募集
- Tampere University Hospital
-
コンタクト：
- Oksala
- 電話番号：+3583311611
- メール：niku.oksala@tuni.fi
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Tampere、フィンランド
- 完了
- Tampere University
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
健康なボランティア
|
IPG signal is measured with ThrombUS+ prototype device
他の名前：
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).
他の名前：
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.
他の名前：
|
|
Patients
DVT detected on other lower limb, undergoing catheter-directed thrombolysis
|
IPG signal is measured with ThrombUS+ prototype device
他の名前：
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).
他の名前：
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.
他の名前：
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
|
Impedance plethysmography (IPG) data during CDT treatment
時間枠：From enrollment to the end of the CDT treatment (up to 2 days)
|
From enrollment to the end of the CDT treatment (up to 2 days)
|
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Impedance plethysmography (IPG) data from healthy volunteers
時間枠：From enrollment to the end of measurements (up to 2 hours)
|
From enrollment to the end of measurements (up to 2 hours)
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- ThrombUS+B4
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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