Endtidal Carbon Dioxide for Earlier Detection of Pulmonary Hypertension (EARLIER)

May 18, 2022 updated by: Sophie Herbst, University of Giessen

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

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Hessen
      • Giessen, Hessen, Germany, 35392
        • University Clinic Giessen and Marburg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients of a tertiary referral center retro- and prospective part of the study.

Afterwards in a next prospective study part patients in ambulant setting.

Description

Inclusion Criteria:

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

Exclusion Criteria:

none

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Diagnostic test: Capnography
Measuring of the exhaled air, especially endtidal co2, through capnography.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurement PetCO2
Time Frame: At baseline
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Establishing a cut-off
Time Frame: At baseline
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Giessen

Investigators

  • Principal Investigator: Henning Gall, MD, PhD, University Clinic Giessen and Marburg - Campus Giessen
  • Study Director: Werner Seeger, Prof., University Clinic Giessen and Marburg
  • Study Director: Ardeschir Ghofrani, Prof., University Clinic Giessen and Marburg

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 2, 2018

Primary Completion (Anticipated)

January 1, 2030

Study Completion (Anticipated)

January 1, 2035

Study Registration Dates

First Submitted

December 22, 2017

First Submitted That Met QC Criteria

December 22, 2017

First Posted (Actual)

January 3, 2018

Study Record Updates

Last Update Posted (Actual)

May 19, 2022

Last Update Submitted That Met QC Criteria

May 18, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AZ 156/17 (Other Identifier: Ethik-Kommission Giessen)
  • DRKS00013589 (Registry Identifier: DRKS)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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