Assessment of Intravascular Volume Status in Mechanically Ventilated Critically Ill PatientsNCT07807709
Evaluation of Jugular Venous Distensibility Index in Intravascular Fluid Management and Comparison of the Effectiveness of Noninvasive and Minimally Invasive Methods
An observational study of Assessment of Intravascular Volume Status in Mechanically Ventilated Critically Ill Patients, run by Gaziosmanpasa Research and Education Hospital at 1 site in Turkey (Türkiye).
Trial summary
Assessment of intravascular volume status is an important component of hemodynamic management in critically ill patients. Several noninvasive and minimally invasive parameters, including the pleth variability index (PVI), pulse pressure variation (PPV), stroke volume variation (SVV), and ultrasonographic measurements… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Assessment of Intravascular Volume Status in Mechanically Ventilated Critically Ill Patients
- What is being tested?
- Pleth variability index, Pulse pressure variation and Stroke volume variation
- How many people
- 82 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2024to 1 Aug 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population consists of adult patients aged 18 years or older who are admitted to the intensive care unit and receiving invasive mechanical ventilation at the time of assessment. Eligible patients have PVI, PPV, and SVV measurements available and technically adequate right internal jugular vein and inferior vena cava ultrasonographic measurements obtained during the same assessment session. Patients with cardiac arrhythmia or unavailable or incomplete hemodynamic or ultrasonographic measurements are excluded.
Who may be able to join
- Adults aged 18 years or older
- Admission to the intensive care unit
- Receiving invasive mechanical ventilation at the time of assessment
- Availability of PVI, PPV, and SVV measurements during the hemodynamic assessment
- Availability of technically adequate right internal jugular vein and inferior vena cava ultrasonographic measurements obtained during the same assessment session
Who cannot join
- Age younger than 18 years
- Presence of cardiac arrhythmia
- Not receiving invasive mechanical ventilation at the time of assessment
- Inability to obtain technically adequate right internal jugular vein or inferior vena cava ultrasonographic images
- Unavailable or incomplete PVI, PPV, or SVV measurements
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gaziosmanpasa Training Research Hospital
Istanbul, 34255
About this study
Assessment of intravascular volume status is an important component of hemodynamic management in critically ill patients. Several noninvasive and minimally invasive parameters, including the pleth variability index (PVI), pulse pressure variation (PPV), stroke volume variation (SVV), and ultrasonographic measurements of venous diameter variation, can be used for this purpose. Although the inferior vena cava distensibility index (IVC-DI) is commonly evaluated using ultrasonography, visualization of the inferior vena cava may be technically difficult or time-consuming in some patients. The right internal jugular vein is more superficial and may therefore provide a faster and more accessible alternative.
The primary aim of this prospective observational study is to evaluate the correlation and agreement between the right internal jugular vein distensibility index (RJV-DI) and IVC-DI in mechanically ventilated adult intensive care unit patients. The secondary aims are to compare the correlations of RJV-DI and IVC-DI with PVI, PPV, and SVV and to compare the acquisition times of the two ultrasonographic measurements. The study will assess whether RJV-DI may provide a practical and faster alternative for hemodynamic assessment, particularly when visualization of the inferior vena cava is difficult.
- Conditions
- Assessment of Intravascular Volume Status in Mechanically Ventilated Critically Ill Patients
- Being tested
- Pleth variability index, Pulse pressure variation, Stroke volume variation, Right jugular vein distensibility index, Inferior Vena Cava Distensibility Index
- Keywords
- fluid management, hemodynamic monitoring, Right Internal Jugular Vein, Inferior Vena Cava, Distensibility Index, Pleth Variability Index, Pulse Pressure Variation, Stroke Volume Variation, Intravascular Volume Status
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pleth variability indexDiagnostic test
Pleth variability index
Pulse pressure variationDiagnostic test
Pulse pressure variation
Stroke volume variationDiagnostic test
Stroke volume variation
Right jugular vein distensibility indexDiagnostic test
Right jugular vein distensibility index
Inferior Vena Cava Distensibility IndexDiagnostic test
Inferior Vena Cava Distensibility Index
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Right Internal Jugular Vein Distensibility Index Inferior Vena Cava Distensibility Index PPV SVV PVI Receives: Diagnostic Test: Pleth variability index; Diagnostic Test: Pulse pressure variation; Diagnostic Test: Stroke volume variation; Diagnostic Test: Right jugular vein distensibility index; Diagnostic Test: Inferior Vena Cava Distensibility Index |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation Between the Right Internal Jugular Vein Distensibility Index and Inferior Vena Cava Distensibility Index
The association between the right internal jugular vein distensibility index (RJV-DI) and inferior vena cava distensibility index (IVC-DI), both expressed as percentages, will be quantified using Spearman's rank correlation coefficient.
Measured: During a single assessment session on Day 1
Secondary outcomes (1)
Difference in Measurement Acquisition Time Between RJV-DI and IVC-DI
The time required to obtain technically adequate RJV-DI and IVC-DI measurements will be recorded in seconds. The paired acquisition times will be compared to determine which ultrasonographic assessment can be performed more rapidly.
Measured: During a single assessment session on Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2026
- Study start1 Jan 2024
- Primary completion1 Jul 2024
- Study completion1 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Assessment of Intravascular Volume Status in Mechanically Ventilated Critically Ill PatientsStudies 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
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gaziosmanpasa Research and Education Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Oguz Özakın, Gaziosmanpasa Research and Education Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07807709
- Sponsor's protocol ID
- 124
- Status last verified
- Aug 2023
- First submitted
- 7 Jul 2023
- Last updated
- 11 Sep 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 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Jugular Venous Distensibility Index in Intravascular Fluid Management and Comparison of the Effectiveness of Noninvasive and Minimally Invasive Methods
- ClinicalTrials.gov ID
- NCT07807709
- Acronym / sponsor ID
- 124
- Conditions
- Assessment of Intravascular Volume Status in Mechanically Ventilated Critically Ill Patients
- Keywords
- fluid management, hemodynamic monitoring, Right Internal Jugular Vein, Inferior Vena Cava, Distensibility Index, Pleth Variability Index, Pulse Pressure Variation, Stroke Volume Variation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Gaziosmanpasa Research and Education HospitalOther government
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 1 Aug 2024 (actual)
- First posted
- 8 Sep 2026 (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.
Assessment of intravascular volume status is an important component of hemodynamic management in critically ill patients. Several noninvasive and minimally invasive parameters, including the pleth variability index (PVI), pulse pressure variation (PPV), stroke volume variation (SVV), and ultrasonographic measurements of venous diameter variation, can be used for this purpose. Although the inferior vena cava distensibility index (IVC-DI) is commonly evaluated using ultrasonography, visualization of the inferior vena cava may be technically difficult or time-consuming in some patients. The right internal jugular vein is more superficial and may therefore provide a faster and more accessible alternative.
The primary aim of this prospective observational study is to evaluate the correlation and agreement between the right internal jugular vein distensibility index (RJV-DI) and IVC-DI in mechanically ventilated adult intensive care unit patients. The secondary aims are to compare the correlations of RJV-DI and IVC-DI with PVI, PPV, and SVV and to compare the acquisition times of the two ultrasonographic measurements. The study will assess whether RJV-DI may provide a practical and faster alternative for hemodynamic assessment, particularly when visualization of the inferior vena cava is difficult.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Group | – | Diagnostic Test: Pleth variability index, Diagnostic Test: Pulse pressure variation, Diagnostic Test: Stroke volume variation, Diagnostic Test: Right jugular vein distensibility index, Diagnostic Test: Inferior Vena Cava Distensibility IndexRight Internal Jugular Vein Distensibility Index Inferior Vena Cava Distensibility Index PPV SVV PVI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of adult patients aged 18 years or older who are admitted to the intensive care unit and receiving invasive mechanical ventilation at the time of assessment. Eligible patients have PVI, PPV, and SVV measurements available and technically adequate right internal jugular vein and inferior vena cava ultrasonographic measurements obtained during the same assessment session. Patients with cardiac arrhythmia or unavailable or incomplete hemodynamic or ultrasonographic measurements are excluded.
Key inclusion criteria (5 listed)
- Adults aged 18 years or older
- Admission to the intensive care unit
- Receiving invasive mechanical ventilation at the time of assessment
- Availability of PVI, PPV, and SVV measurements during the hemodynamic assessment
- Availability of technically adequate right internal jugular vein and inferior vena cava ultrasonographic measurements obtained during the same assessment session
Key exclusion criteria (5 listed)
- Age younger than 18 years
- Presence of cardiac arrhythmia
- Not receiving invasive mechanical ventilation at the time of assessment
- Inability to obtain technically adequate right internal jugular vein or inferior vena cava ultrasonographic images
- Unavailable or incomplete PVI, PPV, or SVV measurements
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 |
|---|---|---|
| Pleth variability indexPleth variability index | Diagnostic test | Study Group |
| Pulse pressure variationPulse pressure variation | Diagnostic test | Study Group |
| Stroke volume variationStroke volume variation | Diagnostic test | Study Group |
| Right jugular vein distensibility indexRight jugular vein distensibility index | Diagnostic test | Study Group |
| Inferior Vena Cava Distensibility IndexInferior Vena Cava Distensibility Index | Diagnostic test | Study Group |
Primary outcome
Correlation Between the Right Internal Jugular Vein Distensibility Index and Inferior Vena Cava Distensibility Index
Time frame: During a single assessment session on Day 1
The association between the right internal jugular vein distensibility index (RJV-DI) and inferior vena cava distensibility index (IVC-DI), both expressed as percentages, will be quantified using Spearman's rank correlation coefficient.
1 secondary outcome
Difference in Measurement Acquisition Time Between RJV-DI and IVC-DI
Time frame: During a single assessment session on Day 1
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 11 Sep 2026.
- Individual participant dataSharing planned: Undecided
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Assessment of Intravascular Volume Status in Mechanically Ventilated Critically Ill Patients, run by Gaziosmanpasa Research and Education Hospital at 1 site in Turkey (Türkiye).
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 5 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 11 Sep 2026. 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 Turkey (Türkiye). 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?
Correlation Between the Right Internal Jugular Vein Distensibility Index and Inferior Vena Cava Distensibility Index (time frame: During a single assessment session on Day 1). 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 11 Sep 2026.