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
Studie Overzicht
Toestand
Studietype
Inschrijving (Geschat)
Contacten en locaties
Studiecontact
- Naam: Nevine Mostafa Soliman, Ass. Prof.
- Telefoonnummer: +201128861471
- E-mail: mostafanevine@gmail.com
Studie Locaties
-
-
Shebin El-Kom
-
Alexandria, Shebin El-Kom, Egypte, 32511
- Werving
- Menoufia University
-
Contact:
- Nevine Mostafa Soliman
- Telefoonnummer: +201128861471
- E-mail: mostafanevine@gmail.com
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Bemonsteringsmethode
Studie Bevolking
- 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.
Beschrijving
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:
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Hepatic vein systolic filling fraction (SFF) and Tricuspid Annular Plane Systolic Excursion (TAPSE)
Tijdsspanne: 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 |
within the first 24 hours
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
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.
Tijdsspanne: 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. |
till 28 days after admission
|
Medewerkers en onderzoekers
Sponsor
Studie record data
Bestudeer belangrijke data
Studie start (Geschat)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Andere studie-ID-nummers
- 6/2026ANET30
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .