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

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ClinicalTrials.gov Identifier: NCT01606839
Recruitment Status : Completed
First Posted : May 28, 2012
Last Update Posted : February 19, 2014
Sponsor:
Collaborator:
Ludwig Boltzmann Gesellschaft
Information provided by (Responsible Party):
Medical University of Graz

Brief 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.

Condition or disease
Pulmonary Hypertension

Detailed 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.


Study Type : Observational
Actual Enrollment : 34 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Noninvasive Measurement of Cardiac Output in Pulmonary Hypertension Using Inert Gas Rebreathing
Study Start Date : February 2012
Actual Primary Completion Date : February 2014
Actual Study Completion Date : February 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. Cardiac output [ Time Frame: at baseline ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study population consists of patients undergoing diagnostic or follow-up right heart cathereization.
Criteria

Inclusion Criteria:

  • Written informed consent
  • Patients who undergo right heart catheterization

Exclusion Criteria:

  • Missing written informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01606839


Locations
Austria
Ludwig Boltzmann Institute for Lung Vascular Research
Graz, Austria
Sponsors and Collaborators
Medical University of Graz
Ludwig Boltzmann Gesellschaft
Investigators
Principal Investigator: Horst Olschewski, MD Medical University of Graz

Responsible Party: Medical University of Graz
ClinicalTrials.gov Identifier: NCT01606839     History of Changes
Other Study ID Numbers: 24-079 ex 11/12
First Posted: May 28, 2012    Key Record Dates
Last Update Posted: February 19, 2014
Last Verified: February 2014

Additional relevant MeSH terms:
Hypertension
Hypertension, Pulmonary
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases