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Comparison of Different Cardiac Output Measurement Methods in Patients Undergoing Right Heart Catheterization

Cardiac Output Assessment in Pulmonary Hypertension Patients Undergoing Right Heart Catheterization

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05665218
Enrollment
1
Registered
2022-12-27
Start date
2022-01-01
Completion date
2024-12-31
Last updated
2022-12-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Hypertension

Brief summary

The objective of this observational study is to compare cardiac output evaluation by the Direct Fick method, Indirect Fick method and Thermodiluition in pulmonary hypertension (PH) patients undergoing right heart catheterization (RHC). The main questions it aims to answer are: * Are these methods interchangeable? * Can possible discrepancies influence risk stratification and therapeutic management of PH patients? All consecutive patients aged ≥18 years, referred for RHC for suspected PH, will be included. Exclusion criteria will be contraindications to RHC, cardiac shunts and failure to obtain informed consent. Patients will undergo RHC by a Swan-Ganz catheter through the right internal jugular vein ultrasound-guided cannulation and cardiac output will be calculated using the three above-mentioned methods.

Interventions

Right heart catheterization (RHC) is an invasive hemodynamic procedure that allows direct measurement of right-sided cardiac pressures, calculation of cardiac output and pulmonary vascular resistance. It is the gold standard for the diagnosis of pulmonary arterial hypertension. Right heart catheterization is commonly performed by accessing the internal jugular vein (echo-guided access). Swan Ganz catheter with a dedicated thermistor is used to perform RHC; it is advanced through the right heart chambers to measure right atrial, right ventricle, pulmonary artery and pulmonary arterial wedge pressures. Cardiac output is measured using Fick direct, Fick indirect and thermodilution methods.

Sponsors

UOSD Emodinamica Diagnostica e Interventistica
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Age ≥18 years * Suspected pulmonary hypertension at clinical and echocardiographic evaluation

Exclusion criteria

* contraindication to Right Heart Catheterization (RHC) * cardiac shunt * inability to provide informed consent

Design outcomes

Primary

MeasureTime frameDescription
differences in cardiac output values measured using three different methods (Direct Fick, Indirect Fick and Thermodiluition)through study completion, an average of 1 yearIn all patients cardiac output will be measured using the three methods to evaluate if the values obtained significantly differ

Countries

Italy

Contacts

Primary ContactLivio Giuliani, MD, PhD
lvgiuliani@gmail.com+390871358978
Backup ContactSerena Rossi, MD
rossisere.rs@gmail.com+390871358978

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026