- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06166875
Accuracy of IVCCI as a Measure of CVP
Accuracy of Inferior Vena Cava Collapsibility Index as a Measure of Central Venous Pressure
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Cairo, Egypt, 11517
- Department of Anesthesiology, Intensive Care, and Pain Management, Faculty of Medicine, Ain Shams University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age: ≥18 years.
- Sex: Both sexes.
- BMI: <35
- Patient in whom central venous cannulation is needed for management.
- Spontaneously breathing patients.
Exclusion Criteria:
- Patients with increased intra abdominal pressure.
- Patients who not able to lie supine.
- Patients on mechanical ventilation.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Derivation Sample
80 patients will be recruited as a derivation sample to calculate the regression equation
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Validation Sample
80 patients will be recruited as a validation sample to test the performance of the equation
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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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
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18 months
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- MD186/2023
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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