Endtidal Carbon Dioxide for Earlier Detection of Pulmonary Hypertension

NCT ID: NCT03388476

Last Updated: 2022-05-19

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Total Enrollment: 500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-05-02
• Study Completion Date: 2035-01-01

Brief 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.

Detailed 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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Capnography

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

Capnography

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

none

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Giessen

OTHER

Sponsor Role: lead

Responsible Party

Sophie Herbst

Study Chair: Ghofrani H. Ardeschir, Prof. Dr. University of Giessen

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Henning Gall, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Clinic Giessen and Marburg - Campus Giessen

Werner Seeger, Prof.

Role: STUDY_DIRECTOR

University Clinic Giessen and Marburg

Ardeschir Ghofrani, Prof.

Role: STUDY_DIRECTOR

University Clinic Giessen and Marburg

Locations

University Clinic Giessen and Marburg

Giessen, Hesse, Germany

Countries

Germany

References

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.

Reference Type: BACKGROUND

PMID: 21622547 (View on PubMed)

Other Identifiers

DRKS00013589

Identifier Type: REGISTRY

Identifier Source: secondary_id

AZ 156/17

Identifier Type: OTHER

Identifier Source: secondary_id

AZ 156/17

Identifier Type: -

Identifier Source: org_study_id