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A Deep Learning Model for Blood Volume Estimation From Multi-modal Ultrasound

Quantitative Estimation of Preoperative Blood Volume Using Multi-modal Ultrasound and Deep Learning

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06957587
Enrollment
800
Registered
2025-05-04
Start date
2025-10-01
Completion date
2027-08-31
Last updated
2025-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Blood Volume Analysis, Machine Learning, Ultrasound

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.

Interventions

None listed

Sponsors

Shanghai 6th People's Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Quantitative estimation of blood volumewithin 30mins before the surgeryWe will estimate the basic blood volume of the patients quantitatively with the Acute Hemodilution technique before the surgery.

Countries

China

Contacts

Primary Contactxiuxiu sun, MD
liuyuanec@163.com021-64369181

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026