Endtidal Carbon Dioxide for Earlier Detection of Pulmonary Hypertension

Lung Diseases Clinical Trial

— EARLIER  

Official title:

Endtidal Carbon Dioxide for Earlier Detection of Pulmonary Hypertension in Patients With Suspicion of Pulmonary Hypertension

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03388476
• Other study ID #: AZ 156/17
• Secondary ID: DRKS00013589AZ 1
• Status: Enrolling by invitation
• Start date: May 2, 2018
• Est. completion date: January 1, 2035

Study information

• Verified date: May 2022
• Source: University of Giessen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 500
• Est. completion date: January 1, 2035
• Est. primary completion date: January 1, 2030
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

none

Related Conditions & MeSH terms

• Chronic Thromboembolic Pulmonary Hypertension
• Hypertension
• Hypertension, Pulmonary
• Hypertension;Pulmonary;Primary
• Lung Diseases
• Vascular Diseases

Intervention

Diagnostic Test:
• Capnography
Measuring of the exhaled air, especially endtidal co2, through capnography.

Locations

Country	Name	City	State
Germany	University Clinic Giessen and Marburg	Giessen	Hessen

Sponsors (1)

Lead Sponsor	Collaborator
University of Giessen

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Hemnes AR, Pugh ME, Newman AL, Robbins IM, Tolle J, Austin ED, Newman JH. End tidal CO(2) tension: pulmonary arterial hypertension vs pulmonary venous hypertension and response to treatment. Chest. 2011 Nov;140(5):1267-1273. doi: 10.1378/chest.11-0155. Epub 2011 May 26. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measurement PetCO2	Measurement PetCO2 by capnography at rest after or before a right heart catheterization, comparison of the parameter between patients with and without	At baseline
Secondary	Establishing a cut-off	Establishing a cut-off for the non-invasive diagnosing of pulmonary hypertension, which differs between patients with and without pulmonary hypertension and save patients without the disease before a dispensable invasive right heart catheterization	At baseline