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NCT Number: NCT07732114

Diagnostic Accuracy of Hepatic Vein SFF Compared With TAPSE for Assessment of RV Systolic Function in Mechanically Ventilated Patients

This prospective observational diagnostic accuracy study investigates the efficacy of the hepatic vein systolic filling fraction (SFF) as a real-time, non-invasive indicator of right ventricular (RV) systolic function in critically ill patients admitted to the intensive care unit.

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Key information

Conditions

Critically Ill Intensive Care Unit Patients

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Menoufia University

Alexandria, Shebin El-Kom, 32511, Egypt

Location status: Recruiting

Location contact

Nevine Mostafa Soliman

CONTACT

[email protected]

+201128861471

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 18 years.
  • Mechanically ventilated patients
  • Patients in whom transthoracic echocardiography (TTE) can be performed Adequate acoustic window to measure TAPSE.
  • Patients in whom hepatic vein Doppler assessment is feasible Adequate subcostal view for Doppler sampling.

Exclusion criteria

Treatment and study plan

Diagnostic accuracy of hepatic vein systolic filling fraction compared with TAPSE for assessment of right ventricular systolic function in mechanically ventilated critically ill patients

Diagnostic Test
  • Point-of-Care Echocardiography Protocol Echocardiograms were recorded within the first 24 hours of ICU admission using an echocardiograph by two intensivists who were experienced in echocardiography (more than 7 years of experience) and will be blinded to the study. Electrocardiograms were recorded continuously during the echocardiographic examination. Images will be saved for offline analysis. The ultrasound machine will be equipped with a phased-array transducer.

Right Ventricular Assessment: From the apical 4-chamber view, the M-mode cursor will be aligned with the lateral aspect of the tricuspid valve annulus to measure the Tricuspid Annular Plane Systolic Excursion (TAPSE). To ensure accuracy and account for beat-to-beat variability, the final TAPSE value recorded for each patient will be the average of measurements taken over three consecutive cardiac cycles. Right ventricular systolic dysfunction (RVSD) is strictly defined as an average TAPSE of < 16 mm (7).

Primary outcomes

  1. Hepatic vein systolic filling fraction (SFF) and Tricuspid Annular Plane Systolic Excursion (TAPSE)

    Time frame: within the first 24 hours

    Hepatic vein systolic filling fraction (SFF) will be measured using colour Doppler ultrasonography of the hepatic vein. Examinations will be performed within a 5-minute window of transthoracic echocardiography and obtained at end-expiration to minimise the effects of respiratory variation. All patients will be mechanically ventilated, and positive end-expiratory pressure (PEEP) and plateau pressure will be recorded at the time of assessment.

    Unit:

    Percentage (%) Right ventricular systolic function will be assessed by measuring tricuspid annular plane systolic excursion (TAPSE) using transthoracic echocardiography at the bedside. Echocardiographic examination will be performed within a 5-minute window of hepatic vein Doppler assessment and obtained at end-expiration to minimise respiratory variation. All patients will be mechanically ventilated, and positive end-expiratory pressure (PEEP) and plateau pressure will be recorded at the time of assessment.

    Unit:

    Millimetres mm

Secondary outcomes

  1. Baseline Demographic and Clinical Data, Synchronized Hemodynamic and Respiratory Data, Total length of ICU stay (days) and ICU mortality and the correlation and agreement between the hepatic vein and RV systolic function via TAPSE.

    Time frame: till 28 days after admission

    To determine the correlation and agreement between the hepatic vein SFF and right ventricular (RV) systolic function Unit of Measure Correlation coefficient (Pearson's r or Spearman's ρ), quantitatively assessed via Tricuspid Annular Plane Systolic Excursion (TAPSE) at the bedside. Tricuspid Annular Plane Systolic Excursion (TAPSE) should be < 16 mm.

    SFF cut-off of ≤ 54.5% for predicting RV dysfunction measured by Agreement statistic (e.g., Cohen's kappa or intraclass correlation coefficient) and diagnostic accuracy measures (sensitivity, specificity, area under the receiver operating characteristic curve) .

    Base line demographic data (wt in kg , height in meter, sex), clinical, laboratory characteristics off all patients and the Sequential Organ Failure Assessment (SOFA) Score by points and the Acute Physiology and Chronic Health Evaluation (APACHE) score by score.

    Total duration of invasive mechanical ventilation in days. Intensive Care Unit (ICU) length of stay in days.

Study contacts

Contact information is provided by the study sponsor or research team.

Nevine Mostafa Soliman, Ass. Prof.

CONTACT

[email protected]

+201128861471

Sponsors and collaborators

Lead sponsor

Menoufia University

Other

Registry information

Official study title

Diagnostic Accuracy of Hepatic Vein Systolic Filling Fraction Compared With TAPSE for Assessment of Right Ventricular Systolic Function in Mechanically Ventilated Critically Ill Patients

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 28, 2026
Registry last updated
Jul 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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