Septic Shock
Conditions
Keywords
Swan-Ganz IQ™, Swan-Ganz, thermodilution, cardiac index.
Brief summary
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_TESTSwan-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.
Sponsors
Assistance Publique - Hôpitaux de Paris
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | 1 day |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 1 day | — |
| Assess whether the agreement between cardiac index measured by thermodilution and that estimated by Swan-Ganz IQ™ varies across different hemodynamic profiles. | 1 day | Investigate whether the agreement between the continuous cardiac index estimated by the Swan-Ganz IQ™ catheter and the cardiac index measured by thermodilution differs according to prespecified hemodynamic phenotypes, particularly in the presence of right ventricular dysfunction, left heart failure, and tricuspid regurgitation grade ≥ 3. |
| 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. | 1 day | — |
| Assess the consistency of changes in cardiac output before and after volume expansion, depending on the use of vasopressors. | 1 day | Assess the concordance between changes in cardiac index measured by thermodilution and those estimated by right ventricular pressure wave analysis before and after volume expansion, depending on the presence or absence of vasopressor treatment at the time of measurement. |
| 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. | 1 day | Evaluate the concordance between variations in cardiac index measured by thermodilution and those of continuous cardiac index estimated by right ventricular pressure wave analysis, before and after a change in norepinephrine dose administered as part of treatment. |
| Determine the least significant change (LSC) in the continuous cardiac index estimated by the Swan-Ganz IQ™ catheter, based on the observed measurement variability. | 1 day | — |
Countries
France
Contacts
CONTACTXavier MONNET, PhD
CONTACTNicolas FAGE, MD, PhD
STUDY_DIRECTORXavier MONNET, PhD
Assistance Publique - Hôpitaux de Paris
Outcome results
None listed