NCT06957587 A Deep Learning Model for Blood Volume Estimation From Multi-modal Ultrasound
| NCT ID | NCT06957587 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Shanghai 6th People's Hospital |
| Condition | Blood Volume Analysis |
| Study Type | OBSERVATIONAL |
| Enrollment | 800 participants |
| Start Date | 2025-10-01 |
| Primary Completion | 2027-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 800 participants in total. It began in 2025-10-01 with a primary completion date of 2027-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
1. Background \& Rationale: Accurate assessment of a patient's blood volume (BV) status before surgery is critical for preventing perioperative complications. However, there is currently no clinically feasible, accurate, and non-invasive method for direct BV quantification. We hypothesize that dynamic ultrasound videos of major blood vessels contain rich, sub-visual spatiotemporal information about vascular compliance and filling that can be leveraged to estimate BV. 2. Objective: To develop and validate a deep learning model that integrates multi-modal ultrasound video data to achieve non-invasive, quantitative estimation of preoperative blood volume. 3. Study Design: A prospective, single-center, observational study. 4. Methods: Participants: Adult patients scheduled for surgery. Data Acquisition: Input (Features): Preoperative ultrasound video clips will be recorded in standardized views of four key vessels: the Internal Jugular Vein (IJV), Subclavian Vein (SCV), Inferior Vena Cava (IVC), and Common Carotid Artery (CA). Target (Label): The true Blood Volume (BV) will be calculated for each patient using the acute normovolemic hemodilution (ANH) method. The change in hemoglobin concentration before and after this process is used to calculate the total blood volume with high clinical reliability. Model Development: A hybrid deep learning architecture (e.g., CNN + LSTM/Transformer) will be trained to extract features from the ultrasound videos and learn the complex, non-linear mapping to the BV value derived from ANH. The model will be trained and internally validated using a k-fold cross-validation approach. 5. Expected Outcome \& Significance: We anticipate the development of a novel, end-to-end deep learning model capable of providing a quantitative BV estimate from routine ultrasound scans. This technology has the potential to revolutionize perioperative fluid management by offering a rapid, non-invasive, and accurate tool for objective volume status assessment, ultimately guiding personalized therapy and improving patient outcomes.
Eligibility Criteria
Inclusion Criteria: * Agree to join this study and sign the informed consent form; * Age between 18 and 75 years old (inclusive); * BMI (body mass index) is between 18 and 30 kg/m2; * American Society of Anesthesiologists (ASA) grades I-II Exclusion Criteria: * Preoperative hemoglobin (Hb) \<10g/dl * Cardiac dysfunction (NYHA class III-IV), respiratory dysfunction (ATS class 2-4), history of liver and kidney dysfunction (such as transaminase / albumin / bilirubin abnormalities, hepatitis history, serum creatinine / urea nitrogen rise, etc.), nervous system abnormalities (those who cannot cooperate due to stroke or its sequelae, Alzheimer, etc.); * The ultrasonic display of inferior vena cava, internal jugular vein, subclavian vein or common carotid artery is extremely poor, venous thrombosis or anatomical abnormalities; * Multiple injury with chest, abdomen or brain; * Pregnant woman
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06957587 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Blood Volume Analysis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06957587 currently recruiting?
Yes, NCT06957587 is actively recruiting participants. Contact the research team at liuyuanec@163.com for enrollment information.
Where is the NCT06957587 trial being conducted?
This trial is being conducted at Shanghai, China, Shanghai, China.
Who is sponsoring the NCT06957587 clinical trial?
NCT06957587 is sponsored by Shanghai 6th People's Hospital. The trial plans to enroll 800 participants.