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Thoracic Fluid Content by Bioimpedance-based Starling System

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05676723
Acronym
TFC-Bio
Enrollment
41
Registered
2023-01-09
Start date
2022-01-18
Completion date
2022-11-02
Last updated
2023-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Respiratory Distress Syndrome, Fluid Overload Pulmonary Edema, Hemodynamic Instability, Shock

Keywords

Acute Respiratory Distress Syndrome, Shock, Hemodynamic Monitoring, Fluid Balance, Pulmonary Edema

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.

Interventions

None listed

Sponsors

Bicetre Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
TFC as marker of cardiac preload or lung water6-9 monthsTo investigate the relationship between TFC measured by bioimpedance and other variables offered by a system of hemodynamic monitoring based on TPTD (Transpulmonary Thermodilutions).

Secondary

MeasureTime frameDescription
Assessement of the determinants of the TFC measured by the Starling System6-9 monthsTo establish the determinants of TFC among hemodynamic variables including EVLW and GEDV.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026