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

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

Study Overview

• Status: Recruiting
• Conditions: Critically Ill Intensive Care Unit Patients
• Intervention / Treatment: Diagnostic test: Diagnostic accuracy of hepatic vein systolic filling fraction compared with TAPSE for assessment of right ventricular systolic function in mechanically ventilated critically ill patients

• Study Type: Observational
• Enrollment (Estimated): 115

Contacts and Locations

• Study Contact: Name: Nevine Mostafa Soliman, Ass. Prof.; Phone Number: +201128861471; Email: mostafanevine@gmail.com

Study Locations

• Egypt
  • Shebin El-Kom
    • Alexandria, Shebin El-Kom, Egypt, 32511
      • Recruiting
      • Menoufia University
      • Contact: Nevine Mostafa Soliman; Phone Number: +201128861471; Email: mostafanevine@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hepatic vein systolic filling fraction (SFF) and Tricuspid Annular Plane Systolic Excursion (TAPSE)	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	within the first 24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	till 28 days after admission

Collaborators and Investigators

• Sponsor: Menoufia University

Study record dates

Study Major Dates

• Study Start (Estimated): September 10, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 15, 2027

Study Registration Dates

• First Submitted: July 18, 2026
• First Submitted That Met QC Criteria: July 27, 2026
• First Posted (Actual): July 28, 2026

Study Record Updates

• Last Update Posted (Actual): September 10, 2026
• Last Update Submitted That Met QC Criteria: September 9, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 6/2026ANET30

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No