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

Sponsor
UOSD Emodinamica Diagnostica e Interventistica (Other)
Overall Status
Recruiting
CT.gov ID
NCT05665218
Collaborator
(none)
1
1
36
0

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: right heart catheterization

Study Design

Study Type:
Observational
Anticipated Enrollment :
1 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Cardiac Output Assessment in Pulmonary Hypertension Patients Undergoing Right Heart Catheterization
Actual Study Start Date :
Jan 1, 2022
Anticipated Primary Completion Date :
Dec 31, 2024
Anticipated Study Completion Date :
Dec 31, 2024

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 UOSD Emodinamica Diagnostica e Interventistica Ospedale SS Annunziata Chieti Italy 66100

Sponsors and Collaborators

  • UOSD Emodinamica Diagnostica e Interventistica

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Livio Giuliani, Livio Giuliani MD, PhD, UOSD Emodinamica Diagnostica e Interventistica
ClinicalTrials.gov Identifier:
NCT05665218
Other Study ID Numbers:
  • CH2022-01
First Posted:
Dec 27, 2022
Last Update Posted:
Dec 27, 2022
Last Verified:
Dec 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 27, 2022