Noninvasive Measurement of Cardiac Output in Pulmonary Hypertension Using Inert Gas Rebreathing

Pulmonary Hypertension Clinical Trial

Official title:

Noninvasive Measurement of Cardiac Output in Pulmonary Hypertension Using Inert Gas Rebreathing

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01606839
• Other study ID #: 24-079 ex 11/12
• Status: Completed
• Phase: N/A
• First received: May 24, 2012
• Last updated: February 18, 2014
• Start date: February 2012
• Est. completion date: February 2014

Study information

• Verified date: February 2014
• Source: Medical University of Graz
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria : Federal Ministry for Labour, Health, and Social Affairs
• Study type: Observational

Clinical Trial Summary

The study hypothesis is that accuracy of CO measurement by IGR does not differ from classical CO measurement methods such as thermodilution or direct Fick method. This is why the study aims to determine whether non invasive cardiac output (CO) measurement using inert gas rebreathing (IGR)is a suitable method in patients with pulmonary hypertension. In order to examine this, the IGR method will be used in patients undergoing diagnostic or follow-up right heart catheterization.

Description:

Inert Gas Rebreathing method enables non invasive measurement of cardiac output (CO) using the single rebreathing method. A mixture of blood soluble (N2O) and blood insoluble gas (SF6) and environmental air is inhaled and the amount of N2O, SF6, O2 and CO2 is measured by a photoacoustic analysator. The length of a measurement is about 1 minute.

As the gold standard measurement of CO is performed invasively, there is an urgent need for the development of non-invasive tools like IGR.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Written informed consent

• Patients who undergo right heart catheterization

Exclusion Criteria:

• Missing written informed consent

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Pulmonary
• Pulmonary Hypertension

Locations

Country	Name	City	State
Austria	Ludwig Boltzmann Institute for Lung Vascular Research	Graz

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of Graz	Ludwig Boltzmann Gesellschaft

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiac output		at baseline	No