Thoracic Fluid Content by Bioimpedance-based Starling System

Acute Respiratory Distress Syndrome Clinical Trial

— TFC-Bio  

Official title:

Assessment of the Determinants of the Thoracic Fluid Content Measured by the Bioimpedance-based Starling System in Critically Ill Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05676723
• Other study ID #: 2018-A02825-50
• Status: Completed
• Start date: January 18, 2022
• Est. completion date: November 2, 2022

Study information

• Verified date: January 2023
• Source: Bicetre Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: November 2, 2022
• Est. primary completion date: August 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age = 18 y.o.

• Hospitalization in an ICU

• Monitoring by transpulmonary thermodilution already in place

• Decision by clinicians in charge to perform volume expansion by saline or fluid removal by diuretics infusion and/or ultrafiltration ("Fluid" group)

• Or presence of Acute Respiratory Distress Syndrome according to the Berlin definition ("ARDS" group)

Exclusion Criteria:

• Refusal to join the study

• In "Fluid" group, circulatory failure whose treatment cannot be postponed for =5 minutes (time required for the installation of Starling system).

• Impossibility to paste bioreactance electrodes properly in the skin of the thorax.

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• Fluid Overload Pulmonary Edema
• Hemodynamic Instability
• Pulmonary Edema
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn
• Shock

Locations

Country	Name	City	State
France	Hopital Kremlin-Bicetre	Le Kremlin-Bicêtre	Île-de-France

Sponsors (1)

Lead Sponsor	Collaborator
Bicetre Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	TFC as marker of cardiac preload or lung water	To investigate the relationship between TFC measured by bioimpedance and other variables offered by a system of hemodynamic monitoring based on TPTD (Transpulmonary Thermodilutions).	6-9 months
Secondary	Assessement of the determinants of the TFC measured by the Starling System	To establish the determinants of TFC among hemodynamic variables including EVLW and GEDV.	6-9 months