Comparison of Cardiac Index Measurement Using Right Ventricular Pressure Curve Analysis and Thermodilution Via a Swan-Ganz IQ™ Catheter.
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- What is being studied
- The protocol lists: Swan-Ganz.
- Who it may be relevant to
- Registry conditions: Septic Shock. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Comparison of Cardiac Index Measurement by Analysis of the Right Ventricular Pressure Curve and by Thermodilution During Pulmonary Artery Catheterization Using Swan Ganz IQ™.
Overview
The pulmonary artery catheter (Swan-Ganz) is a standard tool in intensive care for measuring and monitoring cardiac index by thermodilution. The Swan-Ganz IQ™ model also allows continuous estimation of cardiac index through analysis of the right ventricular pressure wave, which could be useful for rapidly assessing changes in cardiac output during volume expansion response tests. However, the concordance between this continuous method and thermodilution remains poorly studied in real clinical conditions and may vary depending on certain clinical situations. This study therefore aims to compare the cardiac index measured by thermodilution with that estimated by right ventricular pressure waveform analysis based on data collected in clinical practice.
Detailed description
The pulmonary artery catheter (or Swan-Ganz catheter) is a standard tool for measuring and monitoring cardiac index in intensive care. It measures cardiac index using thermodilution, which is considered the gold standard method. The Swan-Ganz IQ™ model also offers continuous measurement of cardiac index by analyzing the right ventricular pressure waveform. The ability to measure cardiac output continuously would allow pulmonary artery catheterization to be used to assess cardiac output during short procedures, such as tests to predict the response to volume expansion (passive leg raising, expiratory pause), and to evaluate its effect on cardiac index. However, the concordance between cardiac output measured by thermodilution (reference method) and that estimated by the continuous method based on analysis of the right ventricular pressure waveform remains poorly evaluated by independent data in real clinical conditions. Furthermore, this agreement may vary depending on the clinical situation, particularly in the presence of right ventricular dysfunction, tricuspid regurgitation, or left heart failure. In this context, this study aims to compare the cardiac index measured by thermodilution with the cardiac index estimated by analyzing the right ventricular pressure waveform, based on data collected in the clinical setting.
Interventions
- Diagnostic test Swan-Ganz
The pulmonary artery catheter (or Swan-Ganz catheter) is a gold-standard tool for measuring and monitoring cardiac index in the intensive care unit. It enables measurement of cardiac index via thermodilution, which is considered the gold standard method. The Swan-Ganz IQ™ model also provides continuous measurement of cardiac index through analysis of the right ventricular pressure wave.
Primary outcome measures
- Evaluate the concordance between cardiac index values provided according to right ventricular pressure waveform and those measured by thermodilution in patients with septic shock who are monitored by a pulmonary. [Time frame: 1 day]
Secondary outcome measures (6)
- Evaluate the concordance between the continuous cardiac index estimated by the Swan-Ganz IQ™ catheter and the cardiac index measured by thermodilution in patients receiving vasopressor therapy, compared to patients not receiving vasopressor therapy. [Time frame: 1 day]
- Assess whether the agreement between cardiac index measured by thermodilution and that estimated by Swan-Ganz IQ™ varies across different hemodynamic profiles. [Time frame: 1 day]
- Assess the concordance between variations in cardiac index measured by thermodilution and those in continuous cardiac index estimated by right ventricular pressure wave analysis, before and after volume expansion performed as part of treatment. [Time frame: 1 day]
- Assess the consistency of changes in cardiac output before and after volume expansion, depending on the use of vasopressors. [Time frame: 1 day]
- Assess the agreement between changes in cardiac output measured by thermodilution and those estimated continuously by analysis of the right ventricular pressure wave, before and after a change in the dose of norepinephrine. [Time frame: 1 day]
- Determine the least significant change (LSC) in the continuous cardiac index estimated by the Swan-Ganz IQ™ catheter, based on the observed measurement variability. [Time frame: 1 day]
Eligibility criteria
Inclusion criteria
- Age ≥ 18 years
- Hospitalization in intensive care
- Presence of a Swan-Ganz IQ™ pulmonary artery catheter placed as part of treatment
- Thermodilution performed by the clinician in charge as part of treatment
Exclusion criteria
- Pregnancy
- Legal protective measures (guardianship, conservatorship, and deprivation of liberty by court/administrative decision)
- Refusal of participation by the patient's relatives or the patient themselves.
- Cardiac output measurements by thermodilution or continuous cardiac output analysis that cannot be used.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 2 centers
- Pierre ASFAR — Angers
- Xavier MONNET — Paris
Identifiers
NCT: NCT07628023 · APHP260231