Clinical trial NCT05676723: Thoracic Fluid Content by Bioimpedance-based Starling System
Official title: Assessment of the Determinants of the Thoracic Fluid Content Measured by the Bioimpedance-based Starling System in Critically Ill Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Respiratory Distress Syndrome
Hemodynamic Instability
Shock
Fluid Overload Pulmonary Edema
Keywords: Acute Respiratory Distress Syndrome
Shock
Hemodynamic Monitoring
Fluid Balance
Pulmonary Edema
Lead sponsor: Bicetre Hospital
Sponsor class: OTHER
First posted: 2023-01-09
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: ICU patients, aged ≥ 18 y.o, monitored by transpulmonary thermodilution will enter the study if:

* a decision by clinicians in charge to perform volume expansion by saline or fluid removal by diuretics infusion and/or ultrafiltration will be taken ("Fluid" group)
* an Acute Respiratory Distress Syndrome (ARDS) will be diagnosed according to the Berlin definition ("ARDS" group)

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.

Eligibility criteria: 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.

Primary outcomes:
measure: TFC as marker of cardiac preload or lung water
timeFrame: 6-9 months
Secondary outcomes:
measure: Assessement of the determinants of the TFC measured by the Starling System
timeFrame: 6-9 months
Other outcomes:
Locations:
city: Le Kremlin-Bicêtre
country: France
facility: Hopital Kremlin-Bicetre
state: Île-de-France
Study officials:
References: