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

This study has been completed.
Sponsor:
Collaborator:
Ludwig Boltzmann Gesellschaft
Information provided by (Responsible Party):
Medical University of Graz
ClinicalTrials.gov Identifier:
NCT01606839
First received: May 24, 2012
Last updated: February 18, 2014
Last verified: February 2014
  Purpose

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
Pulmonary Hypertension

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Noninvasive Measurement of Cardiac Output in Pulmonary Hypertension Using Inert Gas Rebreathing

Resource links provided by NLM:


Further study details as provided by Medical University of Graz:

Primary Outcome Measures:
  • Cardiac output [ Time Frame: at baseline ] [ Designated as safety issue: No ]

Enrollment: 34
Study Start Date: February 2012
Study Completion Date: February 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Medical University of Graz
ClinicalTrials.gov Identifier: NCT01606839     History of Changes
Other Study ID Numbers: 24-079 ex 11/12
Study First Received: May 24, 2012
Last Updated: February 18, 2014
Health Authority: Austria : Federal Ministry for Labour, Health, and Social Affairs

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

ClinicalTrials.gov processed this record on September 18, 2014