IVC Collapsibility IndexNCT06166875
Accuracy of IVCCI as a Measure of CVP
An observational study of IVC Collapsibility Index, run by Nermeen Shawky Ahmed Mohamed at 1 site in Egypt.
Trial summary
The primary aim of the current study is to examine the accuracy of IVCCI for measurement of CVP and to derive equation or formula to predict CVP from IVCCI. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- IVC Collapsibility Index
- How many people
- 160 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Dec 2023to 30 Apr 2025
- 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
- Adult, Older adult
Study population: Adult patients admitted to ICU
Who may be able to join
- Age: ≥18 years.
- Sex: Both sexes.
- BMI: <35
- Patient in whom central venous cannulation is needed for management.
- Spontaneously breathing patients.
Who cannot join
- Patients with increased intra abdominal pressure.
- Patients who not able to lie supine.
- Patients on mechanical ventilation.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Department of Anesthesiology, Intensive Care, and Pain Management, Faculty of Medicine, Ain Shams University
Cairo, 11517
About this study
Official title: Accuracy of Inferior Vena Cava Collapsibility Index as a Measure of Central Venous Pressure
The primary aim of the current study is to examine the accuracy of IVCCI for measurement of CVP and to derive equation or formula to predict CVP from IVCCI.
Read the detailed description
Hemodynamic monitoring is important in the management of patients in the intensive care unit (ICU) Assessment of the intravascular volume, infusion of fluids or vasoactive drugs and maintenance of an adequate systemic perfusion is essential for reduction of the risk of organ failure and/or mortality.
The use of CVP through central venous catheter is a gold standard method that is extensively used in the ICU as it reflects the filling pressure of the right ventricle (RV) and RV preload.
Central venous cannulation has significant complications such as pneumothorax, hemothorax, arterial puncture, catheter malposition, cardiac arrhythmias, venous embolism, subcutaneous hematoma, and catheter related infection, and it is difficult to use this method in an emergency situation as it requires skilled personnel.
Measurement of IVC index by bedside ultrasound is widely used to assess the intravascular volume in adult patients and has the advantage of being non-invasive, rapid, and reliable for assessing the volume status.
Besides, related measures such as IVC diameter, IVC collapsibility, and IVC to aorta (AO) diameter have been applied clinically to assess the volume status and have been related to CVP.
- Conditions
- IVC Collapsibility Index
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 |
|---|---|---|
| Derivation Sample | 80 patients will be recruited as a derivation sample to calculate the regression equation | |
| Validation Sample | 80 patients will be recruited as a validation sample to test the performance of the equation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome of the current study is to examine the accuracy of IVCCI for measurement of CVP and to derive equation or formula to predict CVP from IVCCI.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2023
- Study start15 Dec 2023
- Primary completion30 Apr 2025
- Study completion30 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for IVC Collapsibility IndexStudies 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
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nermeen Shawky Ahmed Mohamed
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nermeen Shawky Ahmed Mohamed, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06166875
- Sponsor's protocol ID
- MD186/2023
- Status last verified
- May 2025
- First submitted
- 4 Dec 2023
- Last updated
- 28 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hakim SM, Ahmed NS, Talaat SM, Wasfy SF, Haggag AM. Development and validation of a proposed rule for estimating central venous pressure from inferior vena cava dynamics: a clinical prediction model study. J Anesth Analg Crit Care. 2026 Jul 29;6(1):104. doi: 10.1186/s44158-026-00438-z.
PubMed 42527946
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of Inferior Vena Cava Collapsibility Index as a Measure of Central Venous Pressure
- ClinicalTrials.gov ID
- NCT06166875
- Acronym / sponsor ID
- MD186/2023
- Conditions
- IVC Collapsibility Index
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Nermeen Shawky Ahmed MohamedUniversity, hospital or other
- Study start
- 15 Dec 2023 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 12 Dec 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 primary aim of the current study is to examine the accuracy of IVCCI for measurement of CVP and to derive equation or formula to predict CVP from IVCCI.
Detailed description
Hemodynamic monitoring is important in the management of patients in the intensive care unit (ICU) Assessment of the intravascular volume, infusion of fluids or vasoactive drugs and maintenance of an adequate systemic perfusion is essential for reduction of the risk of organ failure and/or mortality.
The use of CVP through central venous catheter is a gold standard method that is extensively used in the ICU as it reflects the filling pressure of the right ventricle (RV) and RV preload.
Central venous cannulation has significant complications such as pneumothorax, hemothorax, arterial puncture, catheter malposition, cardiac arrhythmias, venous embolism, subcutaneous hematoma, and catheter related infection, and it is difficult to use this method in an emergency situation as it requires skilled personnel.
Measurement of IVC index by bedside ultrasound is widely used to assess the intravascular volume in adult patients and has the advantage of being non-invasive, rapid, and reliable for assessing the volume status.
Besides, related measures such as IVC diameter, IVC collapsibility, and IVC to aorta (AO) diameter have been applied clinically to assess the volume status and have been related to CVP.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Derivation Sample | – | –80 patients will be recruited as a derivation sample to calculate the regression equation |
| Validation Sample | – | –80 patients will be recruited as a validation sample to test the performance of the equation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adult patients admitted to ICU
Key inclusion criteria (5 listed)
- Age: ≥18 years.
- Sex: Both sexes.
- BMI: <35
- Patient in whom central venous cannulation is needed for management.
- Spontaneously breathing patients.
Key exclusion criteria (3 listed)
- Patients with increased intra abdominal pressure.
- Patients who not able to lie supine.
- Patients on mechanical ventilation.
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
The primary outcome of the current study is to examine the accuracy of IVCCI for measurement of CVP and to derive equation or formula to predict CVP from IVCCI.
Time frame: 18 months
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 28 May 2026.
- Derived from this study: PubMed 42527946Hakim SM, Ahmed NS, Talaat SM, Wasfy SF, Haggag AM. Development and validation of a proposed rule for estimating central venous pressure from inferior vena cava dynamics: a clinical prediction model study. J Anesth Analg Crit Care. 2026 Jul 29;6(1):104. doi: 10.1186/s44158-026-00438-z.
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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.
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 IVC Collapsibility Index, run by Nermeen Shawky Ahmed Mohamed at 1 site in Egypt.
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: finished, as of the sponsor's last update on 28 May 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 Egypt. 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?
The primary outcome of the current study is to examine the accuracy of IVCCI for measurement of CVP and to derive equation or formula to predict CVP from IVCCI. (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06166875, which also lists 1 linked publication.
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 28 May 2026.