DVT - Deep Vein Thrombosis, POCUS
Conditions
Brief summary
This study aims to develop and evaluate a wearable ultrasound imaging sensor for the early diagnosis and real-time monitoring of various diseases, such as cardiovascular conditions and structural abnormalities of superficial organs. With advancements in medical technology, wearable devices have attracted increasing attention for their portability and real-time capabilities.
Interventions
OTHERThis study is designed to assess the non-inferiority of a novel ultrasound imaging technique, rather than to evaluate a therapeutic intervention.
This study is designed to assess the non-inferiority of a novel ultrasound imaging technique, rather than to evaluate a therapeutic intervention.
Sponsors
Chinese PLA General Hospital
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* Age ≥ 18 yrs and able to consent * Relevant diagnosis for study arm (heart failure, lower-limb DVT, or ICU monitoring) * Adequate acoustic window and intact skin at sensor site Arm-specific: * Heart-failure arm: Clinically stable HFrEF or HFpEF on standard therapy * DVT arm: Imaging-confirmed lower-limb DVT, anticoagulated or scheduled for intervention * ICU arm: ICU/post-op patient requiring continuous bedside ultrasound
Exclusion criteria
* Poor acoustic window preventing interpretable images * Local skin infection, open wound, or implant/hardware blocking sensor * Inability to cooperate with monitoring Arm-specific: * Heart-failure arm: Acute MI or uncontrolled arrhythmia in past 3 months * DVT arm: Active bleeding or severe coagulopathy * ICU arm: Unstable multi-organ failure precluding safe monitoring
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Image Quality | Day 1 (Baseline): Measured immediately after first wearable sensor placement | * Signal-to-Noise Ratio (SNR) * Unit: decibels (dB) * Contrast-to-Noise Ratio (CNR) * Unit: decibels (dB) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Consistency of image quality | Day 1 (Baseline): Measured immediately after first wearable sensor placement | Image Clarity Score Unit: 5-point Likert scale (1 = poor to 5 = excellent) |
Countries
China
Contacts
CONTACTYuyang Li, PhD
PRINCIPAL_INVESTIGATORYukun Luo, Professor, M.D.
Chinese PLA General Hospital
Outcome results
None listed