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

NCT07732114 | Recruiting

• 1 other identifier: 6/2026ANET30
• Study Type: observational
• Target: 115
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Critically Ill Intensive Care Unit Patients

Outcome Measures

Primary Outcomes (1)

• 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 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.

  till 28 days after admission

Interventions

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

1\. 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).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

Sponsors & Collaborators

• Menoufia University: lead

Study Sites (1)

Menoufia University

Alexandria, Shebin El-Kom, 32511, Egypt

RECRUITING

Central Study Contacts

Nevine Mostafa Soliman, Ass. Prof.

CONTACT

+201128861471; mostafanevine@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ass. Prof.

Study Record Dates

• First Submitted: July 18, 2026
• First Posted: July 28, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 15, 2027
• Last Updated: July 28, 2026

Record last verified: 2026-07

Locations

EG (1)