- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07732114
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
Studieoversigt
Status
Betingelser
Undersøgelsestype
Tilmelding (Anslået)
Kontakter og lokationer
Studiekontakt
- Navn: Nevine Mostafa Soliman, Ass. Prof.
- Telefonnummer: +201128861471
- E-mail: mostafanevine@gmail.com
Studiesteder
-
-
Shebin El-Kom
-
Alexandria, Shebin El-Kom, Egypten, 32511
- Rekruttering
- Menoufia University
-
Kontakt:
- Nevine Mostafa Soliman
- Telefonnummer: +201128861471
- E-mail: mostafanevine@gmail.com
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Prøveudtagningsmetode
Studiebefolkning
- 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.
Beskrivelse
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:
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Hepatic vein systolic filling fraction (SFF) and Tricuspid Annular Plane Systolic Excursion (TAPSE)
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
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.
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 6/2026ANET30
Plan for individuelle deltagerdata (IPD)
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