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

Recruiting

• Conditions: Pulmonary Hypertension
• Interventions: Diagnostic Test: right heart catheterization

• Registration Number: NCT05665218
• Lead Sponsor: UOSD Emodinamica Diagnostica e Interventistica

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-01
• Status Verified: 2022-12
• Study First Submitted: 2022-12-08
• Study First Submitted QC: 2022-12-16
• Last Update Submitted: 2022-12-16
• Study First Posted: 2022-12-27
• Last Update Posted: 2022-12-27
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
patients undergoing right heart catheterization	right heart catheterization	-

Primary Outcome Measures

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

Trial Locations

Locations (1)

UOSD Emodinamica Diagnostica e Interventistica Ospedale SS Annunziata; 🇮🇹 Chieti, Italy