UltrasoundNCT06957587
Intelligent Classification of Intraoperative Hemodynamic Phenotypes Based on CADFlow Doppler Monitoring
An observational study of Ultrasound and Machine Learning, run by Shanghai 6th People's Hospital at 2 sites in China.
Trial summary
The goal of this observational study is to learn about intraoperative hemodynamic phenotypes in adult patients undergoing elective surgery under general anesthesia, using a new wearable ultrasound patch (CADFlow) that continuously monitors carotid and jugular blood flow. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ultrasound, Machine Learning, Intraoperative Hypotension
- How many people
- 440 participants
- Where
- 2 sitesChina
- Study dates
- 1 Nov 2026to 30 Jun 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients scheduled for elective, supine, general-anaesthesia surgery.
Who may be able to join
- Provides written informed consent to participate in the study;
- Age 18 years or older;
- Body mass index (BMI) between 18 and 30 kg/m2;
- American Society of Anesthesiologists (ASA) physical status class I-III;
- Scheduled for elective, supine, tracheal-intubation general-anaesthesia surgery
Who cannot join
- Severe cardiac arrhythmia (e.g., atrial fibrillation, frequent premature ventricular contractions) that compromises signal accuracy;
- Pregnancy;
- Anatomical abnormality of the carotid artery or jugular vein, or extremely poor ultrasound signal quality.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites
Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Shanghai, Shanghai Municipality, 200235
xiuxiu sun, Mrs, 021-64369181-56428, liuyuanec@163.com
Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Shanghai, Shanghai Municipality, 200235
aizhong wang, PhD, 021-64369181 ext. 56980, 18930177431@163.com
xiaofeng wang, MD
About this study
Official title: Intelligent Classification of Intraoperative Hemodynamic Phenotypes Based on CADFlow Continuous Carotid and Jugular Doppler Monitoring: A Prospective Observational Study
The goal of this observational study is to learn about intraoperative hemodynamic phenotypes in adult patients undergoing elective surgery under general anesthesia, using a new wearable ultrasound patch (CADFlow) that continuously monitors carotid and jugular blood flow. The main question it aims to answer is:
Can a machine learning model built solely on non-invasive carotid and jugular Doppler data accurately identify and classify a patient's hemodynamic phenotype in real time during surgery? Participants undergoing routine elective surgery who are monitored with the CADFlow device as part of standard care will be recorded continuously from after tracheal intubation until the end of surgery. The collected signals will be used to discover distinct hemodynamic phenotypes and to train a model that classifies each patient's phenotype in real time.
Read the detailed description
Accurate and continuous assessment of intraoperative hemodynamic status is fundamental to perioperative safety. Marked intraoperative hemodynamic instability is closely associated with postoperative complications and mortality, making precise hemodynamic management a central goal of perioperative medicine. Since the 1970s, hemodynamic profiling has relied primarily on parameters obtained from the pulmonary artery catheter (PAC); the four-quadrant framework built on pulmonary artery occlusion pressure (PAOP) and cardiac index (CI) - such as the Forrester-Diamond classification - distinguishes "warm-dry", "warm-wet", "cold-dry" and "cold-wet" phenotypes and remains a classic element of critical-care teaching. However, PAC placement is an invasive procedure carrying risks such as pulmonary-artery rupture and arrhythmias, which limits its routine use in surgical patients.
Machine learning (ML) has increasingly been explored for hemodynamic phenotype classification, and unsupervised methods have shown particular promise. Geri et al. identified five cardiovascular phenotypes in septic shock by combining clinical and echocardiographic data; Guinot et al. identified three congestion-related phenotypes in ICU patients using clinical, biomarker and Doppler data; and Kouz et al. and Jian et al. identified endotypes of intraoperative hypotension in surgical cohorts using hierarchical clustering and autoencoder-based deep clustering, respectively. Nevertheless, these studies share common limitations: most depend on invasive arterial or PAC-derived parameters; they capture arterial-side flow information only and lack venous indices needed to assess preload and right-heart function; and the complexity of ML "black-box" models raises the need to benchmark them against simpler, more cost-effective approaches.
CADFlow is a novel wireless, wearable Doppler-ultrasound patch that continuously and noninvasively monitors carotid artery and jugular vein hemodynamic parameters simultaneously. Its fully noninvasive design (a probe applied to the neck) avoids the risks of arterial puncture or PAC insertion, eliminates operator-dependent variability, and provides both carotid parameters (VTI, ccFT, peak systolic velocity Vs, dP/dt) and jugular parameters (Jvti, mean jugular flow jTAV, jugular pulsatility index jPI, jugular filling index JVI). This dual arterial-and-venous information is not available from arterial-only Doppler or invasive monitoring, and the resulting multimodal feature set is expected to improve the resolution, physiological interpretability and performance of unsupervised phenotype classification.
This study aims to apply CADFlow multimodal data and unsupervised learning to automatically discover intraoperative hemodynamic phenotypes and, on this basis, to develop a real-time phenotype classification model, thereby providing new tools and evidence for intelligent perioperative hemodynamic management
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Adult patients scheduled for elective surgery | Adult patients aged 18 years or older scheduled for elective, supine, tracheal-intubation general-anaesthesia surgery will be enrolled into a single observational cohort. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Real-time phenotype classification performance of the machine-learning model
Using the phenotype labels derived from unsupervised clustering of intraoperative CADFlow multimodal data, a supervised learning model will be trained to classify the current intraoperative hemodynamic phenotype in real time. Performance will be assessed by accuracy, macro-averaged AUC and macro-averaged F1-score.
Measured: Intraoperatively, from completion of tracheal intubation to the end of surgery
Secondary outcomes (2)
Phenotype feature-profile characterisation
Distribution of CADFlow parameters across the discovered phenotypes (box/ violin plots) to verify physiological interpretability
Measured: Intraoperative
Stability and interpretability of the unsupervised clustering solution
Stability and interpretability of the unsupervised clustering solution (Silhouette coefficient, Calinski-Harabasz index, Bootstrap stability) and the association between phenotypes and intraoperative events such as hypotension and vasopressor use.
Measured: Intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2025
- Study start1 Nov 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UltrasoundStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 440 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai 6th People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaofeng WANG, Shanghai 6th People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06957587
- Sponsor's protocol ID
- 2025-KY-228(K)
- Status last verified
- Oct 2026
- First submitted
- 26 Apr 2025
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intelligent Classification of Intraoperative Hemodynamic Phenotypes Based on CADFlow Continuous Carotid and Jugular Doppler Monitoring: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT06957587
- Acronym / sponsor ID
- 2025-KY-228(K)
- Conditions
- Ultrasound, Machine Learning, Intraoperative Hypotension, Hemodynamic Monitoring, Hemodynamic Phenotype / Endotype
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 440 participants (estimated)
- Lead sponsor
- Shanghai 6th People's HospitalUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 4 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this observational study is to learn about intraoperative hemodynamic phenotypes in adult patients undergoing elective surgery under general anesthesia, using a new wearable ultrasound patch (CADFlow) that continuously monitors carotid and jugular blood flow. The main question it aims to answer is:
Can a machine learning model built solely on non-invasive carotid and jugular Doppler data accurately identify and classify a patient's hemodynamic phenotype in real time during surgery? Participants undergoing routine elective surgery who are monitored with the CADFlow device as part of standard care will be recorded continuously from after tracheal intubation until the end of surgery. The collected signals will be used to discover distinct hemodynamic phenotypes and to train a model that classifies each patient's phenotype in real time.
Detailed description
Accurate and continuous assessment of intraoperative hemodynamic status is fundamental to perioperative safety. Marked intraoperative hemodynamic instability is closely associated with postoperative complications and mortality, making precise hemodynamic management a central goal of perioperative medicine. Since the 1970s, hemodynamic profiling has relied primarily on parameters obtained from the pulmonary artery catheter (PAC); the four-quadrant framework built on pulmonary artery occlusion pressure (PAOP) and cardiac index (CI) - such as the Forrester-Diamond classification - distinguishes "warm-dry", "warm-wet", "cold-dry" and "cold-wet" phenotypes and remains a classic element of critical-care teaching. However, PAC placement is an invasive procedure carrying risks such as pulmonary-artery rupture and arrhythmias, which limits its routine use in surgical patients.
Machine learning (ML) has increasingly been explored for hemodynamic phenotype classification, and unsupervised methods have shown particular promise. Geri et al. identified five cardiovascular phenotypes in septic shock by combining clinical and echocardiographic data; Guinot et al. identified three congestion-related phenotypes in ICU patients using clinical, biomarker and Doppler data; and Kouz et al. and Jian et al. identified endotypes of intraoperative hypotension in surgical cohorts using hierarchical clustering and autoencoder-based deep clustering, respectively. Nevertheless, these studies share common limitations: most depend on invasive arterial or PAC-derived parameters; they capture arterial-side flow information only and lack venous indices needed to assess preload and right-heart function; and the complexity of ML "black-box" models raises the need to benchmark them against simpler, more cost-effective approaches.
CADFlow is a novel wireless, wearable Doppler-ultrasound patch that continuously and noninvasively monitors carotid artery and jugular vein hemodynamic parameters simultaneously. Its fully noninvasive design (a probe applied to the neck) avoids the risks of arterial puncture or PAC insertion, eliminates operator-dependent variability, and provides both carotid parameters (VTI, ccFT, peak systolic velocity Vs, dP/dt) and jugular parameters (Jvti, mean jugular flow jTAV, jugular pulsatility index jPI, jugular filling index JVI). This dual arterial-and-venous information is not available from arterial-only Doppler or invasive monitoring, and the resulting multimodal feature set is expected to improve the resolution, physiological interpretability and performance of unsupervised phenotype classification.
This study aims to apply CADFlow multimodal data and unsupervised learning to automatically discover intraoperative hemodynamic phenotypes and, on this basis, to develop a real-time phenotype classification model, thereby providing new tools and evidence for intelligent perioperative hemodynamic management
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult patients scheduled for elective surgery | – | –Adult patients aged 18 years or older scheduled for elective, supine, tracheal-intubation general-anaesthesia surgery will be enrolled into a single observational cohort. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients scheduled for elective, supine, general-anaesthesia surgery.
Key inclusion criteria (5 listed)
- Provides written informed consent to participate in the study;
- Age 18 years or older;
- Body mass index (BMI) between 18 and 30 kg/m2;
- American Society of Anesthesiologists (ASA) physical status class I-III;
- Scheduled for elective, supine, tracheal-intubation general-anaesthesia surgery
Key exclusion criteria (3 listed)
- Severe cardiac arrhythmia (e.g., atrial fibrillation, frequent premature ventricular contractions) that compromises signal accuracy;
- Pregnancy;
- Anatomical abnormality of the carotid artery or jugular vein, or extremely poor ultrasound signal quality.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Real-time phenotype classification performance of the machine-learning model
Time frame: Intraoperatively, from completion of tracheal intubation to the end of surgery
Using the phenotype labels derived from unsupervised clustering of intraoperative CADFlow multimodal data, a supervised learning model will be trained to classify the current intraoperative hemodynamic phenotype in real time. Performance will be assessed by accuracy, macro-averaged AUC and macro-averaged F1-score.
2 secondary outcomes
Phenotype feature-profile characterisation
Time frame: Intraoperative
Stability and interpretability of the unsupervised clustering solution
Time frame: Intraoperative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ultrasound and Machine Learning, run by Shanghai 6th People's Hospital at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact xiuxiu sun, MD (021-64369181 ext. 56428, liuyuanec@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Real-time phenotype classification performance of the machine-learning model (time frame: Intraoperatively, from completion of tracheal intubation to the end of surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.