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

December 16, 2022 updated by: Livio Giuliani, UOSD Emodinamica Diagnostica e Interventistica

Cardiac Output Assessment in Pulmonary Hypertension Patients Undergoing Right Heart Catheterization

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
      • Chieti, Italy, 66100
        • Recruiting
        • UOSD Emodinamica Diagnostica e Interventistica Ospedale SS Annunziata
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All consecutive patients aged ≥18 years, referred for RHC for suspected PH, were included.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
patients undergoing right heart catheterization
Diagnostic test: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
differences in cardiac output values measured using three different methods (Direct Fick, Indirect Fick and Thermodiluition)
Time Frame: through study completion, an average of 1 year
In all patients cardiac output will be measured using the three methods to evaluate if the values obtained significantly differ
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UOSD Emodinamica Diagnostica e Interventistica

Investigators

  • Principal Investigator: Livio Giuliani, MD PhD, Interventional Cardiology Unit, SS Annunziata Hospital, Chieti

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2022

Primary Completion (Anticipated)

December 31, 2024

Study Completion (Anticipated)

December 31, 2024

Study Registration Dates

First Submitted

December 8, 2022

First Submitted That Met QC Criteria

December 16, 2022

First Posted (Estimate)

December 26, 2022

Study Record Updates

Last Update Posted (Estimate)

December 26, 2022

Last Update Submitted That Met QC Criteria

December 16, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CH2022-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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