Comparison of Cardiac Index Measurement Using Right Ventricular Pressure Curve Analysis and Thermodilution Via a Swan-Ganz IQ™ Catheter. (MICAP)

Comparison of Cardiac Index Measurement by Analysis of the Right Ventricular Pressure Curve and by Thermodilution During Pulmonary Artery Catheterization Using Swan Ganz IQ™.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Septic Shock
• Intervention / Treatment: Diagnostic test: Swan-Ganz

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.

• Study Type: Observational
• Enrollment (Estimated): 43

Contacts and Locations

• Study Contact: Name: Xavier MONNET, PhD; Phone Number: 0145213539; Email: xavier.monnet@aphp.fr
• Study Contact Backup: Name: Nicolas FAGE, MD, PhD; Email: nicolas.fage@aphp.fr

Study Locations

• France
  • Angers, France, 49100
    • Pierre ASFAR
    • Contact: Pierre ASFAR, PhD; Email: piasfar@chu-angers.fr
  • Paris, France, 94000
    • Xavier MONNET
    • Contact: Xavier MONNET, PhD; Phone Number: 0145213539; Email: xavier.monnet@aphp.fr
    • Contact: Nicolas FAGE, MD, PhD; Email: nicolas.fage@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients hospitalized in medical ICU (of Bicêtre and Angers) with pulmonary arterial catheter (PAC) place as part of routine clinical care.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Study Director: Xavier MONNET, PhD, Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Estimated): June 10, 2026
• Primary Completion (Estimated): June 10, 2028
• Study Completion (Estimated): June 10, 2028

Study Registration Dates

• First Submitted: June 1, 2026
• First Submitted That Met QC Criteria: June 1, 2026
• First Posted (Actual): June 4, 2026

Study Record Updates

• Last Update Posted (Actual): June 4, 2026
• Last Update Submitted That Met QC Criteria: June 1, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Swan-Ganz IQ™, Swan-Ganz, thermodilution, cardiac index.
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Sepsis; Systemic Inflammatory Response Syndrome; Inflammation; Shock; Pathological Conditions, Signs and Symptoms; Shock, Septic; Investigative Techniques; Therapeutics; Diagnostic Techniques and Procedures; Diagnosis; Surgical Procedures, Operative; Catheterization; Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Minimally Invasive Surgical Procedures; Diagnostic Techniques, Cardiovascular; Heart Function Tests; Cardiac Catheterization; Catheterization, Peripheral; Catheterization, Swan-Ganz
• Other Study ID Numbers: APHP260231

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No