POCUS
Conditions
Interventions
Clinical Study of Non-invasive Imaging with Wearable Sensors:This study is designed to assess the non-inferiority of a novel ultrasound imaging technique, rather than to evaluate a therapeutic interve
Sponsors
Harbin Institute of Technology
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: General Inclusion Criteria: Aged >= 18 years; the participant is capable of fully understanding the purpose of the study and signing the informed consent form; The participant meets the clinical diagnostic criteria for the respective application area and is able to cooperate with wearable ultrasound sensor testing, ensuring the acquisition of clear ultrasound images suitable for subsequent analysis; No local skin lesions or other physical conditions that may interfere with the proper functioning of the device during the examination. Cardiac Function Assessment (Structural Heart Disease and Heart Failure with Different Ejection Fraction Levels): 1 Diagnosed with heart failure based on clinical evaluation and conventional echocardiography, and classified by ejection fraction as either heart failure with reduced ejection fraction (HFrEF) or heart failure with preserved ejection fraction (HFpEF); 2 Cardiac function is stable prior to testing, with no recent acute coronary events (e.g., acute myocardial infarction), severe arrhythmia, or other acute systemic illnesses that may affect cardiac function assessment; 3 The patient has a well-established treatment regimen and can maintain a relatively stable condition during the monitoring period. DVT Ablation Monitoring: Diagnosed with deep vein thrombosis (DVT) via conventional ultrasound, CT, or MRI, and currently undergoing interventional or pharmacological treatment; The thrombus location, size, and morphology are suitable for dynamic monitoring, and the patient is hemodynamically stable and not in the acute phase; INR is within an appropriate range, with no severe coagulation disorders or acute bleeding risk. ICU/Bedside Multi-organ Dynamic Monitoring: Critically ill ICU patients or those in postoperative recovery requiring dynamic observation of multiple organs (e.g., bladder volume monitoring); The patient’s condition is stable, suitable for bedside continuous ultrasound monitoring, and not in an acute crisis state; No significant surgical intervention limitations, mobility restrictions, or local trauma that would interfere with ultrasound monitoring.
Exclusion criteria
Exclusion criteria: General Exclusion Criteria: Individuals with limited ultrasound acoustic windows or poor image quality due to physiological or pathological reasons; Presence of systemic diseases that may interfere with examination results or participant compliance; Local skin infections, open wounds, or any condition that may hinder proper sensor attachment and normal operation. Cardiac Function Assessment: Exclusion of individuals with recent (e.g., within the past 3 months) acute myocardial infarction, severe arrhythmia, pericardial effusion, or other acute events that may rapidly alter cardiac function; Exclusion of patients with end-stage renal failure, severe pulmonary dysfunction, or other systemic conditions that affect cardiac load status; Exclusion of individuals unable to tolerate prolonged continuous monitoring or unable to cooperate with device fixation or operation. DVT Ablation Monitoring : Exclusion of patients with severe coagulopathy, active bleeding, or other acute bleeding risks; Exclusion of those with severe local infections, skin ulcers, or trauma that may impair local ultrasound imaging; Exclusion of individuals with extensive hematomas in the lower limbs or other abnormalities that may interfere with hemodynamic measurements. ICU/Bedside Multi-organ Dynamic Monitoring: Exclusion of patients with conditions such as severe infection, local surgical trauma, external fixation devices, or body position limitations that prevent acquisition of clear ultrasound images; Exclusion of patients with severe organ failure or unstable multiple organ dysfunction, rendering them unsuitable for continuous monitoring.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Image Quality;Consistency of image quality; | — |
Secondary
| Measure | Time frame |
|---|---|
| Heart ultrasound images; | — |
Countries
China
Contacts
Public ContactZhang Jia
Harbin Institute of Technology
Outcome results
None listed