Ignite Creation Date:
2024-05-06 @ 6:29 PM
Last Modification Date:
2024-10-26 @ 2:48 PM
Study NCT ID:
NCT05676723
Status:
COMPLETED
Last Update Posted:
2023-01-09
First Post:
2022-11-15
Brief Title:
Thoracic Fluid Content by Bioimpedance-based Starling System
Sponsor:
Bicetre Hospital
Organization:
Bicetre Hospital
Study Overview
Official Title:
Assessment of the Determinants of the Thoracic Fluid Content Measured by the Bioimpedance-based Starling System in Critically Ill Patients
Status:
COMPLETED
Status Verified Date:
2023-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TFC-Bio
Brief Summary:
The Starling system is a completely non-invasive hemodynamic monitoring technique It is able to measure the thoracic fluid content TFC The TFC is supposed to reflect the total content of fluid in the thorax Thus TFC may include two of the variables that are commonly used for hemodynamic monitoring the extravascular lung water EVLW and the global end-diastolic volume GEDV However whether the TFC actually reflects GEDV and EVLW has not been clearly established The objective of the study is to establish the determinants of TFC among hemodynamic variables including EVLW and GEDV
Detailed Description:
The Starling system is a completely non-invasive hemodynamic monitoring technique It measures cardiac output through bioreactance It also measures the mean transthoracic electric impedance Z0 from which the thoracic fluid content TFC can be derived The TFC is the only other variable that is provided by the system besides cardiac output and that is not inferred from it The TFC is supposed to reflect the total content of fluid in the thorax and may include two of the variables that are commonly used for hemodynamic monitoring the extravascular lung water EVLW which is the volume of lung edema and the global end-diastolic volume GEDV which is a static index of cardiac preload Cardiac preload is an important physiological variable a prerequisite for TFC as a reflect cardiac preload would be that its changes are tightly linked to the changes in well-established markers of cardiac preload as the GEDV measured by transpulmonary thermodilution or the central venous pressure CVP Nevertheless this has never been demonstrated In addition TFC includes the volume of EVLW which is the volume of fluid contend in the lungs outside the pulmonary vessels Nevertheless the degree to which TFC is influenced by absolute values and changes in EVLW has never been established The objective of the study is to establish the determinants of TFC among well-known hemodynamic variables including EVLW and GEDV as well the value of TFC as a marker of cardiac preload and lung water
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None