Peripheral VeinNCT06734650
Deep Learning Model for Predicting a Peripheral Venous Waveform-based Pulse Pressure Variation
An observational study of Peripheral Vein and Arterial Wave Reflections, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial summary
Pulse pressure variation is a monitoring index that indicates the response to fluid therapy in patients receiving mechanical ventilation, and is used as a reference for patients with unstable hemodynamic conditions. However, it is invasive because it requires arterial puncture to collect it. Read more about this study
- Who is it for?
- Ages 19 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Peripheral Vein, Arterial Wave Reflections, Pulse Pressure Variation
- What is being tested?
- peripheral waveform collection
- How many people
- 150 participants
- Where
- 1 siteSouth Korea
- Study dates
- 28 Dec 2024to 28 Nov 2026
- How long will I take part?
- 1 Day
- 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 19 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients scheduled for elective hepatectomy under general anesthesia
Who may be able to join
- Patients who voluntarily agreed and signed the written informed consent form before participating in this study
- Adult aged 19 years or older
- American Society of Anesthesiologists physical class (ASA) 1-3
- Patients scheduled for elective hepatectomy under general anesthesia
- Patients who require arterial pressure monitoring and additional peripheral venous access for routine anesthesia preparation
- Non-smokers with normal pulmonary function
Who cannot join
- Patients with abnormal findings on electrocardiogram before surgery
- Patients who cannot undergo peripheral venous puncture
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site
Seoul National University Bundang Hospital
Seongnam-si, Gyunggi-do, 13620
About this study
Official title: Development and Validation of a Peripheral Venous Waveform-based Pulse Pressure Variation Calculating Deep Learning Model
Pulse pressure variation is a monitoring index that indicates the response to fluid therapy in patients receiving mechanical ventilation, and is used as a reference for patients with unstable hemodynamic conditions. However, it is invasive because it requires arterial puncture to collect it. In a previous study by the investigators, the investigators developed and verified an artificial intelligence model that predicts stroke volume variation, in real time using only the central venous pressure waveform. However, since a large vein such as the jugular vein must be punctured to collect the central venous pressure waveform, it is still invasive, and its clinical utility is low. Therefore, in this study, the investigators collected waveforms from peripheral veins that are less invasive and can be a wide range of applications because all surgical patients have them. The investigators aimed to develop and verify an artificial intelligence model that predicts pulse pressure variation obtained from peripheral venous waveforms .
Read the detailed description
In this study, the investigators collected waveforms from peripheral veins that are less invasive and can be a wide range of applications because all surgical patients have them. The investigators aimed to develop and verify an artificial intelligence model that predicts pulse pressure variation obtained from peripheral venous waveforms .
- Conditions
- Peripheral Vein, Arterial Wave Reflections, Pulse Pressure Variation, Stroke Volume Variation, Deep Learning Model
- Being tested
- peripheral waveform collection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
peripheral waveform collectionOther
The peripheral venous pressure waveform is collected by connecting a pressure transducer that is currently in use to the placed central venous line. In addition, the pulse pressure variation or stroke volume variation value that can be obtained from the arterial catheter. This extracts the medical records and bio-signal information of the subjects registered through the previously approved 'Establishment of a Bio-signal and Clinical Information Registry for the Development of Patient Monitoring Algorithm' study (B-2202-738-401).
| Study group | Role | What they receive |
|---|---|---|
| Peripheral waveform collection group | 1. Peripheral Venous Pressure Variation
2. Stroke Volume Variation
3. Pulse Pressure Variation
4. Pleth Variability Index Receives: Other: peripheral waveform collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulse pressure variation
from arterial waveform
Measured: intraoperative period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2024
- Study start28 Dec 2024 (estimated)
- Primary completion28 Nov 2025 (estimated)
- Study completion28 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral VeinStudies 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
- 150 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Park InSun, Seoul National University Bundang Hospital
- Investigators
- Insun Park, M.D./Ph.D., Principal investigator, assistant professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06734650
- Sponsor's protocol ID
- B-2411-936-303
- Status last verified
- Dec 2024
- First submitted
- 10 Dec 2024
- Last updated
- 16 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of a Peripheral Venous Waveform-based Pulse Pressure Variation Calculating Deep Learning Model
- ClinicalTrials.gov ID
- NCT06734650
- Acronym / sponsor ID
- B-2411-936-303
- Conditions
- Peripheral Vein, Arterial Wave Reflections, Pulse Pressure Variation, Stroke Volume Variation, Deep Learning Model
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- 28 Dec 2024 (estimated)
- Primary completion
- 28 Nov 2025 (estimated)
- Study completion
- 28 Nov 2026 (estimated)
- First posted
- 16 Dec 2024 (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.
Pulse pressure variation is a monitoring index that indicates the response to fluid therapy in patients receiving mechanical ventilation, and is used as a reference for patients with unstable hemodynamic conditions. However, it is invasive because it requires arterial puncture to collect it. In a previous study by the investigators, the investigators developed and verified an artificial intelligence model that predicts stroke volume variation, in real time using only the central venous pressure waveform. However, since a large vein such as the jugular vein must be punctured to collect the central venous pressure waveform, it is still invasive, and its clinical utility is low. Therefore, in this study, the investigators collected waveforms from peripheral veins that are less invasive and can be a wide range of applications because all surgical patients have them. The investigators aimed to develop and verify an artificial intelligence model that predicts pulse pressure variation obtained from peripheral venous waveforms .
Detailed description
In this study, the investigators collected waveforms from peripheral veins that are less invasive and can be a wide range of applications because all surgical patients have them. The investigators aimed to develop and verify an artificial intelligence model that predicts pulse pressure variation obtained from peripheral venous waveforms .
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Peripheral waveform collection group | – | Other: peripheral waveform collection1. Peripheral Venous Pressure Variation 2. Stroke Volume Variation 3. Pulse Pressure Variation 4. Pleth Variability Index |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled for elective hepatectomy under general anesthesia
Key inclusion criteria (6 listed)
- Patients who voluntarily agreed and signed the written informed consent form before participating in this study
- Adult aged 19 years or older
- American Society of Anesthesiologists physical class (ASA) 1-3
- Patients scheduled for elective hepatectomy under general anesthesia
- Patients who require arterial pressure monitoring and additional peripheral venous access for routine anesthesia preparation
Key exclusion criteria (2 listed)
- Patients with abnormal findings on electrocardiogram before surgery
- Patients who cannot undergo peripheral venous puncture
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| peripheral waveform collectionThe peripheral venous pressure waveform is collected by connecting a pressure transducer that is currently in use to the placed central venous line. In addition, the pulse pressure variation or stroke volume variation value that can be obtained from the arterial catheter. This extracts the medical records and bio-signal information of the subjects registered through the previously approved 'Establishment of a Bio-signal and Clinical Information Registry for the Development of Patient Monitoring Algorithm' study (B-2202-738-401). | Other | Peripheral waveform collection group |
Primary outcome
Pulse pressure variation
Time frame: intraoperative period
from arterial waveform
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 16 Dec 2024.
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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.
Insun Park, M.D./Ph.D. principal investigator
assistant professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Vein and Arterial Wave Reflections, run by Seoul National University Bundang Hospital at 1 site in South Korea.
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 6 inclusion and 2 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 16 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. 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 Insun Park, M.D./Ph.D. (82317877499, pis121@hanmail.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulse pressure variation (time frame: intraoperative period). 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 16 Dec 2024.