Pulse Pressure VariationNCT06733389
Peripheral Venous Pressure Variation, Pulse Pressure Variation and Pleth Variability Index for Fluid Responsiveness
An observational study of Pulse Pressure Variation and Stroke Volume Variation, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial summary
Pulse pressure variation (PPV) and pleth variability index (PVI) are widely used in clinical practice as indicators of the responsiveness to fluid therapy in patients receiving mechanical ventilation. Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Pulse Pressure Variation, Stroke Volume Variation, Pleth Variability Index
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients scheduled for elective hepatectomy under general anesthesia
Who may be able to join
- Patients voluntarily agreed and signed the written informed consent form before participating in the study
- Adults 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: Comparison of Peripheral Venous Pressure Variation, Pulse Pressure Variation and Pleth Variability Index in Predicting Fluid Responsiveness
Pulse pressure variation (PPV) and pleth variability index (PVI) are widely used in clinical practice as indicators of the responsiveness to fluid therapy in patients receiving mechanical ventilation. PPV, which measures changes in arterial pressure, requires arterial puncture, which is invasive, and PVI, which detects subtle changes in oxygen saturation, requires an expensive, commercial monitoring equipment. In this study, we aimed to measure peripheral venous pressure variation using less invasive waveform variation in peripheral veins and to determine whether this indicator can be clinically used to predict the responsiveness to fluid therapy. In addition, the investigators aimed to confirm the superiority of the indicators by comparing them with the responsiveness to fluid therapy of the PPV and PVI.
Read the detailed description
Pulse pressure variation (PPV) and pleth variability index (PVI) are widely used in clinical practice as indicators of the responsiveness to fluid therapy. The investigators aimed to measure peripheral venous pressure variation using less invasive waveform variation in peripheral veins and to determine whether this indicator can be clinically used to predict the responsiveness to fluid therapy.
- 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 is collected by connecting a pressure transducer that is currently in use to the central venous line. In addition, pulse pressure variation and stroke volume variation that can be obtained from the arterial catheter. In addition, the pleth variability index is collected through the oxygen saturation monitoring. 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 Algorithms' (B-2202-738-401).
| Study group | Role | What they receive |
|---|---|---|
| peripheral waveform collection group | 1. Peripheral Venous Pressure Variation
2. Pulse Pressure Variation
3. 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.
Fluid responsiveness
Cardiac output increases by more than 15% after 250 mL crystalloid injection during a fluid challenge
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 posted13 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 Pulse Pressure VariationStudies 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, Principal investigator, assistant professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06733389
- Sponsor's protocol ID
- B-2412-941-301
- Status last verified
- Dec 2024
- First submitted
- 10 Dec 2024
- Last updated
- 17 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 17 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Peripheral Venous Pressure Variation, Pulse Pressure Variation and Pleth Variability Index in Predicting Fluid Responsiveness
- ClinicalTrials.gov ID
- NCT06733389
- Acronym / sponsor ID
- B-2412-941-301
- 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
- 13 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 (PPV) and pleth variability index (PVI) are widely used in clinical practice as indicators of the responsiveness to fluid therapy in patients receiving mechanical ventilation. PPV, which measures changes in arterial pressure, requires arterial puncture, which is invasive, and PVI, which detects subtle changes in oxygen saturation, requires an expensive, commercial monitoring equipment. In this study, we aimed to measure peripheral venous pressure variation using less invasive waveform variation in peripheral veins and to determine whether this indicator can be clinically used to predict the responsiveness to fluid therapy. In addition, the investigators aimed to confirm the superiority of the indicators by comparing them with the responsiveness to fluid therapy of the PPV and PVI.
Detailed description
Pulse pressure variation (PPV) and pleth variability index (PVI) are widely used in clinical practice as indicators of the responsiveness to fluid therapy. The investigators aimed to measure peripheral venous pressure variation using less invasive waveform variation in peripheral veins and to determine whether this indicator can be clinically used to predict the responsiveness to fluid therapy.
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. Pulse Pressure Variation 3. Pleth Variability Index |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled for elective hepatectomy under general anesthesia
Key inclusion criteria (6 listed)
- Patients voluntarily agreed and signed the written informed consent form before participating in the study
- Adults 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 is collected by connecting a pressure transducer that is currently in use to the central venous line. In addition, pulse pressure variation and stroke volume variation that can be obtained from the arterial catheter. In addition, the pleth variability index is collected through the oxygen saturation monitoring. 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 Algorithms' (B-2202-738-401). | Other | peripheral waveform collection group |
Primary outcome
Fluid responsiveness
Time frame: intraoperative period
Cardiac output increases by more than 15% after 250 mL crystalloid injection during a fluid challenge
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 17 Dec 2024.
Related trials for Pulse Pressure Variation
RecruitingObservational study
Dynamic Arterial Elastance for Prediction of Vasopressor Requirement After Anesthesia Induction in Elective On-Pump CABG
Coronary Artery Disease
RecruitingObservational study
Association Between Intraoperative Pulse Pressure Variation and Postoperative Lactate Clearance in Cardiac Surgery
Coronary Artery Disease
Recruiting
Hemodynamic Effects of Bilateral and Unilateral Spinal Anesthesia Using the Continuous Pressure Recording Analytical Method.
Spinal Anesthesia, Hemodynamic Changes
RecruitingObservational study
Respiratory Variation of Carotid Doppler Peak Velocity (CDPV) for Non-invasive Prediction of Fluid Responsiveness
Hemodynamic Instability
Not yet recruitingObservational study
Comparison of PPV and LVOT VTI During Passive Leg Raising to Predict Fluid Responsiveness
Hemodynamic Instability, Hypovolemia
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 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 Pulse Pressure Variation and Stroke Volume Variation, 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 17 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. (823178777499, pis121@hanmail.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fluid responsiveness (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 17 Dec 2024.