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

NCT05665218 | Unknown

• 1 other identifier: CH2022-01
• Study Type: observational
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Hypertension

Outcome Measures

Primary Outcomes (1)

• differences in cardiac output values measured using three different methods (Direct Fick, Indirect Fick and Thermodiluition)

  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

Study Arms (1)

patients undergoing right heart catheterization

Diagnostic Test: right heart catheterization

Interventions

right heart catheterization 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.

patients undergoing right heart catheterization

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

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• UOSD Emodinamica Diagnostica e Interventistica: lead

Study Sites (1)

UOSD Emodinamica Diagnostica e Interventistica Ospedale SS Annunziata

Chieti, 66100, Italy

RECRUITING

MeSH Terms

Conditions

Hypertension, Pulmonary

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Livio Giuliani, MD PhD

  Interventional Cardiology Unit, SS Annunziata Hospital, Chieti

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Livio Giuliani, MD, PhD

CONTACT

+390871358978; lvgiuliani@gmail.com

Serena Rossi, MD

CONTACT

+390871358978; rossisere.rs@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Livio Giuliani MD, PhD

Study Record Dates

• First Submitted: December 8, 2022
• First Posted: December 27, 2022
• Study Start: January 1, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: December 27, 2022

Record last verified: 2022-12

Locations

IT (1)