Thoracic Fluid Content by Bioimpedance-based Starling System

NCT05676723 | Completed

• 1 other identifier: 2018-A02825-50
• Study Type: observational
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Assessement of the determinants of the TFC measured by the Starling System

  6-9 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bicetre Hospital: lead

Study Sites (1)

Hopital Kremlin-Bicetre

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

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome; Shock; Pulmonary Edema

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 15, 2022
• First Posted: January 9, 2023
• Study Start: January 18, 2022
• Primary Completion: August 31, 2022
• Study Completion: November 2, 2022
• Last Updated: January 9, 2023

Record last verified: 2023-01

Locations

FR (1)