Thoracic Fluid Content by Bioimpedance-based Starling System (TFC-Bio)

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

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.

Study Overview

• Status: Completed
• Conditions: Shock; Acute Respiratory Distress Syndrome; Hemodynamic Instability; Fluid Overload Pulmonary Edema

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 Type: Observational
• Enrollment (Actual): 41

Contacts and Locations

Study Locations

• France
  • Île-de-France
    • Le Kremlin-Bicêtre, Île-de-France, France, 94720
      • Hôpital Kremlin-Bicêtre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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)

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Bicetre Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 18, 2022
• Primary Completion (Actual): August 31, 2022
• Study Completion (Actual): November 2, 2022

Study Registration Dates

• First Submitted: November 15, 2022
• First Submitted That Met QC Criteria: January 6, 2023
• First Posted (Estimate): January 9, 2023

Study Record Updates

• Last Update Posted (Estimate): January 9, 2023
• Last Update Submitted That Met QC Criteria: January 6, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Shock; Acute Respiratory Distress Syndrome; Fluid Balance; Hemodynamic Monitoring; Pulmonary Edema
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Infant, Newborn, Diseases; Lung Injury; Infant, Premature, Diseases; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury; Pulmonary Edema
• Other Study ID Numbers: 2018-A02825-50

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No