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Completed

NCT Number: NCT05676723

Thoracic Fluid Content by Bioimpedance-based Starling System

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hopital Kremlin-Bicetre

Le Kremlin-Bicêtre, Île-de-France Region, 94720, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. TFC as marker of cardiac preload or lung water

    Time frame: 6-9 months

    To investigate the relationship between TFC measured by bioimpedance and other variables offered by a system of hemodynamic monitoring based on TPTD (Transpulmonary Thermodilutions).

Secondary outcomes

  1. Assessement of the determinants of the TFC measured by the Starling System

    Time frame: 6-9 months

    To establish the determinants of TFC among hemodynamic variables including EVLW and GEDV.

Sponsors and collaborators

Lead sponsor

Bicetre Hospital

Other

Registry information

Official study title

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

Acronym: TFC-Bio

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jan 9, 2023
Registry last updated
Jan 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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