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

NCT ID: NCT05665218

Last Updated: 2022-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-01-01

Study Completion Date

2024-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Pulmonary Hypertension

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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patients undergoing right heart catheterization

right heart catheterization

Intervention Type DIAGNOSTIC_TEST

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.

Interventions

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right heart catheterization

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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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UOSD Emodinamica Diagnostica e Interventistica

OTHER

Sponsor Role lead

Responsible Party

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Livio Giuliani

Livio Giuliani MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Livio Giuliani, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Interventional Cardiology Unit, SS Annunziata Hospital, Chieti

Locations

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UOSD Emodinamica Diagnostica e Interventistica Ospedale SS Annunziata

Chieti, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Livio Giuliani, MD, PhD

Role: CONTACT

Phone: +390871358978

Email: [email protected]

Serena Rossi, MD

Role: CONTACT

Phone: +390871358978

Email: [email protected]

Facility Contacts

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Livio Giuliani, MD PhD

Role: primary

Serena Rossi, MD

Role: backup

Other Identifiers

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CH2022-01

Identifier Type: -

Identifier Source: org_study_id