Endtidal Carbon Dioxide for Earlier Detection of Pulmonary Hypertension

Study Purpose

Measurement of the endtidal carbon dioxide by capnography to exclude or to ensure the diagnosis pulmonary hypertension. The aim of the study is to obtain an endtidal carbon dioxide cut-off value for the diagnostic algorithm for pulmonary hypertension as an easily measurable and cheap diagnostic tool in patients with suspicion of pulmonary hypertension.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

Age > 18 years, suspicion of pulmonary hypertension, planned or accomplished right heart catheterization.

Exclusion Criteria:

none

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03388476
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

University of Giessen
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Henning Gall, MD, PhDWerner Seeger, Prof.Ardeschir Ghofrani, Prof.
Principal Investigator Affiliation University Clinic Giessen and Marburg - Campus GiessenUniversity Clinic Giessen and MarburgUniversity Clinic Giessen and Marburg
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Enrolling by invitation
Countries Germany
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Hypertension, Pulmonary, Hypertension;Pulmonary;Primary, Chronic Thromboembolic Pulmonary Hypertension, Vascular Diseases, Lung Diseases
Additional Details

The disease pulmonary hypertension is due to a remodeling of the lung vessels which results in a change of the exhaled air. This change is measurable with a so called capnograph. The investigators want to measure the breath from patients with and without pulmonary hypertension to detect a cut-off value for the diagnosis pulmonary hypertension. Patients which have the probably diagnosis pulmonary hypertension and are older than 18 years are investigated. This patients will get an right heart catheterization and a measurement from their exhaled air.

Arms & Interventions

Arms

: Suspicion of pulmonary hypertension

At Patients with suspicion of pulmonary hypertension, which get a right heart catheterization, in the context of the study the exhaled air, precious the endtidal carbon dioxide (CO2), before or after the right heart catheterization will be measured through capnography.

Interventions

Diagnostic Test: - Capnography

Measuring of the exhaled air, especially endtidal co2, through capnography.

Contact a Trial Team

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International Sites

University Clinic Giessen and Marburg, Giessen, Hessen, Germany

Status

Address

University Clinic Giessen and Marburg

Giessen, Hessen, 35392

For more information, please contact PHA at Research@PHAssociation.org and refer to the terms of service below.

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