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

NCT07628023 | Not Yet Recruiting

• 1 other identifier: APHP260231
• Study Type: observational
• Target: 43
• Locations: 1 country
• Sites: 2

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.

Conditions

Septic Shock

Keywords

Swan-Ganz IQ™, Swan-Ganz, thermodilution, cardiac index.

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (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.

  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

• 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 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

Interventions

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.

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

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (2)

Pierre ASFAR

Angers, 49100, France

Location

Xavier MONNET

Paris, 94000, France

Location

MeSH Terms

Conditions

Shock, Septic

Interventions

Catheterization, Swan-Ganz

Condition Hierarchy (Ancestors)

Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Intervention Hierarchy (Ancestors)

Cardiac Catheterization; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Catheterization, Peripheral; Catheterization; Therapeutics; Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques

Study Officials

• Xavier MONNET, PhD

  Assistance Publique - Hôpitaux de Paris

  STUDY DIRECTOR

Central Study Contacts

Xavier MONNET, PhD

CONTACT

0145213539; xavier.monnet@aphp.fr

Nicolas FAGE, MD, PhD

CONTACT

nicolas.fage@aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2026
• First Posted: June 4, 2026
• Study Start: June 10, 2026
• Primary Completion (Estimated): June 10, 2028
• Study Completion (Estimated): June 10, 2028
• Last Updated: June 4, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)