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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Swan-Ganz | Diagnostic Test | 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. |
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients hospitalized in medical ICU (of Bicêtre and Angers) with pulmonary arterial catheter (PAC) place as part of routine clinical care.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xavier MONNET, PhD | Contact | 0145213539 | xavier.monnet@aphp.fr | |
| Nicolas FAGE, MD, PhD | Contact | nicolas.fage@aphp.fr |
| Name | Affiliation | Role |
|---|---|---|
| Xavier MONNET, PhD | Assistance Publique - Hôpitaux de Paris | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pierre ASFAR | Angers | 49100 | France |
|
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| ID | Term |
|---|---|
| D012772 | Shock, Septic |
| ID | Term |
|---|---|
| D018805 | Sepsis |
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
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| ID | Term |
|---|---|
| D002407 | Catheterization, Swan-Ganz |
| ID | Term |
|---|---|
| D006328 | Cardiac Catheterization |
| D006334 | Heart Function Tests |
| D003935 | Diagnostic Techniques, Cardiovascular |
| D019937 | Diagnostic Techniques and Procedures |
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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. |
| 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. | 1 day |
| Assess the consistency of changes in cardiac output before and after volume expansion, depending on the use of vasopressors. | 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. | 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. | 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. | 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. | 1 day |
| Xavier MONNET | Paris | 94000 | France |
|
| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012769 | Shock |
| D003933 | Diagnosis |
| D002406 | Catheterization, Peripheral |
| D002404 | Catheterization |
| D013812 | Therapeutics |
| D057510 | Endovascular Procedures |
| D014656 | Vascular Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |
| D008919 | Investigative Techniques |