Actively Recruiting

Age: 18Years - 75Years
All Genders
NCT06957587

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

Led by Shanghai 6th People's Hospital · Updated on 2025-11-17

800

Participants Needed

2

Research Sites

99 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Agree to join this study and sign the informed consent form
  • Age between 18 and 75 years old (inclusive)
  • Body mass index (BMI) between 18 and 30 kg/m2
  • American Society of Anesthesiologists (ASA) physical status grades I or II
Not Eligible

You will not qualify if you...

  • Preoperative hemoglobin (Hb) less than 10 g/dl
  • Cardiac dysfunction classified as NYHA class III-IV
  • Respiratory dysfunction classified as ATS class 2-4
  • History of liver or kidney dysfunction, including abnormal transaminase, albumin, bilirubin, hepatitis history, or elevated serum creatinine/urea nitrogen
  • Nervous system abnormalities preventing cooperation, such as stroke, Alzheimer disease, or related sequelae
  • Poor ultrasound imaging of inferior vena cava, internal jugular vein, subclavian vein, or common carotid artery
  • Presence of venous thrombosis or anatomical abnormalities in these vessels
  • Multiple injuries involving chest, abdomen, or brain
  • Pregnancy

AI-Screening

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Trial Site Locations

Total: 2 locations

1

Shanghai Jiao Tong University Affiliated Sixth People's Hospital

Shanghai, Shanghai Municipality, China, 200235

Not Yet Recruiting

2

Shanghai Jiao Tong University Affiliated Sixth People's Hospital

Shanghai, Shanghai Municipality, China, 200235

Actively Recruiting

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Research Team

X

xiuxiu sun, MD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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