Fluid ResponsivenessNCT05930600
Internal Jugular Venous Distensibility Index and Innominate Venous Flow Patterns As Predictors of Fluid Responsiveness
An observational study of Fluid Responsiveness and Hemodynamic Monitoring, run by Universitas Indonesia at 1 site in Indonesia.
Trial summary
The measurement of internal jugular vein distensibility index corresponds to the measurement of stroke volume using trans-thoracic Doppler echocardiography in assessing the response to fluid administration in elective surgical patients. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Fluid Responsiveness, Hemodynamic Monitoring
- What is being tested?
- Ultrasonography of Internal Jugular Vein and Doppler Echocardiograhy
- Type of treatment
- Medical device
- How many people
- 79 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Jun 2023to 5 Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult patients aged 18-65 years undergoing elective surgery with general anesthesia at RSUPN dr. Cipto Mangunkusumo Jakarta.
Who may be able to join
- Utilizing intraoperative mechanical ventilation with a tidal volume of 8 ml/kg (PBW).
- ASA physical status 1-3.
- Mongoloid ethnicity.
- Willing to participate in the research and sign the informed consent.
Who cannot join
- Patients with symptoms and signs of fluid overload, such as pulmonary edema, pleural effusion, ascites, and peripheral edema.
- Patients with chronic or acute kidney dysfunction, renal replacement therapy history, and/or oliguria (urine output <0.5 ml/kg/hour).
- Patients with cardiovascular diseases, including heart failure, cardiac arrhythmias, moderate-to-severe valvular abnormalities, a history of angina/myocardial infarction, pulmonary hypertension, and peripheral artery disease.
- Patients with anatomical abnormalities in the neck and chest region that make it impractical to perform jugular vein ultrasound and transthoracic echocardiography.
- Jugular vein thrombosis.
- Superior vena cava syndrome.
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- Placement of jugular vein catheter.
- Body mass index (BMI) greater than 30.0 kg/m2.
- Patients with contraindications to the use of muscle relaxants.
- Patients with lung hyperinflation and pleural effusion.
- Drop out criteria:
- Patients who wish to withdraw from the study.
- Post-anesthesia induction complications and emergencies.
- Transthoracic echocardiography provides a less representative image due to difficult acoustic window.
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Rumah Sakit Cipto Mangunkusumo
Jakarta Pusat, DKI Jakarta, 10430
About this study
Official title: Internal Jugular Venous Distensibility Index and Innominate Venous Flow Patterns As Predictors of Response to Fluid Administration in Elective Surgery Patients
The measurement of internal jugular vein distensibility index corresponds to the measurement of stroke volume using trans-thoracic Doppler echocardiography in assessing the response to fluid administration in elective surgical patients.
- Conditions
- Fluid Responsiveness, Hemodynamic Monitoring
- Being tested
- Ultrasonography of Internal Jugular Vein, Doppler Echocardiograhy
- Keywords
- Internal Jugular Venous Distensibility Index, Innominate Venous Flow Patterns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasonography of Internal Jugular VeinDevice
Non invasive monitoring of fluid responsiveness
Doppler EchocardiograhyDevice
Non invasive monitoring of fluid responsiveness
What is being measured
The primary outcome is the main question the study is designed to answer.
IJV distensibility index correlation to fluid responsiveness
Correlation between IJV distensibility index and fluid responsiveness defined as increase of stroke volume more than 10% after fluid challenge
Measured: 1 day
Secondary outcomes (4)
Comparison of IJV distensibility index in fluid responders and non-fluid responders.
Measured: 1 day
Detection of sensitivity, specificity, positive predictive value, negative predictive value, and best cut off value of IJV distensibility index to predict fluid responsiveness
By ROC curve and Youden index
Measured: 1 day
Correlation of IJV distensibility index and stroke volume
Measured: 1 day
Innominate vein flow velocity correlation to fluid responsiveness
Correlation between Innominate vein flow velocity and fluid responsiveness defined as increase of stroke volume more than 10% after fluid challenge
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2023
- Study start1 Jun 2023
- Primary completion31 Jul 2023
- Study completion5 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fluid ResponsivenessStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dita Aditianingsih, Universitas Indonesia
- Investigators
- Dita Aditianingsih, Principal investigator, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05930600
- Sponsor's protocol ID
- IndonesiaUAnes044
- Status last verified
- Mar 2025
- First submitted
- 26 Jun 2023
- Last updated
- 5 Mar 2025
- 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 5 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internal Jugular Venous Distensibility Index and Innominate Venous Flow Patterns As Predictors of Response to Fluid Administration in Elective Surgery Patients
- ClinicalTrials.gov ID
- NCT05930600
- Acronym / sponsor ID
- IndonesiaUAnes044
- Conditions
- Fluid Responsiveness, Hemodynamic Monitoring
- Keywords
- Internal Jugular Venous Distensibility Index, Innominate Venous Flow Patterns
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 31 Jul 2023 (actual)
- Study completion
- 5 Sep 2023 (actual)
- First posted
- 5 Jul 2023 (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 measurement of internal jugular vein distensibility index corresponds to the measurement of stroke volume using trans-thoracic Doppler echocardiography in assessing the response to fluid administration in elective surgical patients.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients aged 18-65 years undergoing elective surgery with general anesthesia at RSUPN dr. Cipto Mangunkusumo Jakarta.
Key inclusion criteria (4 listed)
- Utilizing intraoperative mechanical ventilation with a tidal volume of 8 ml/kg (PBW).
- ASA physical status 1-3.
- Mongoloid ethnicity.
- Willing to participate in the research and sign the informed consent.
Key exclusion criteria (14 listed)
- Patients with symptoms and signs of fluid overload, such as pulmonary edema, pleural effusion, ascites, and peripheral edema.
- Patients with chronic or acute kidney dysfunction, renal replacement therapy history, and/or oliguria (urine output <0.5 ml/kg/hour).
- Patients with cardiovascular diseases, including heart failure, cardiac arrhythmias, moderate-to-severe valvular abnormalities, a history of angina/myocardial infarction, pulmonary hypertension, and peripheral artery disease.
- Patients with anatomical abnormalities in the neck and chest region that make it impractical to perform jugular vein ultrasound and transthoracic echocardiography.
- Jugular vein thrombosis.
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 |
|---|---|---|
| Ultrasonography of Internal Jugular VeinNon invasive monitoring of fluid responsiveness | Device | – |
| Doppler EchocardiograhyNon invasive monitoring of fluid responsiveness | Device | – |
Primary outcome
IJV distensibility index correlation to fluid responsiveness
Time frame: 1 day
Correlation between IJV distensibility index and fluid responsiveness defined as increase of stroke volume more than 10% after fluid challenge
4 secondary outcomes
Comparison of IJV distensibility index in fluid responders and non-fluid responders.
Time frame: 1 day
Detection of sensitivity, specificity, positive predictive value, negative predictive value, and best cut off value of IJV distensibility index to predict fluid responsiveness
Time frame: 1 day
Correlation of IJV distensibility index and stroke volume
Time frame: 1 day
Innominate vein flow velocity correlation to fluid responsiveness
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2025.
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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. This study is not recruiting at the moment.
Dita Aditianingsih principal investigator
Universitas Indonesia
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 Fluid Responsiveness and Hemodynamic Monitoring, run by Universitas Indonesia at 1 site in Indonesia.
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 4 inclusion and 14 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: finished, as of the sponsor's last update on 5 Mar 2025. 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 Indonesia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IJV distensibility index correlation to fluid responsiveness (time frame: 1 day). 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 5 Mar 2025.