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

ConditionSeptic Shock
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAssistance Publique - Hôpitaux de Paris

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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.

Treatment groups

No treatment groups listed

Trial outcomes

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.

Time frame
1 day

Secondary outcomes

1

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
2

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.

Time frame
1 day
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.

Time frame
1 day
4

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.

Time frame
1 day

Other outcomes

Sponsors and contacts

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