Endtidal Carbon Dioxide for Earlier Detection of Pulmonary Hypertension

NCT03388476 | Enrolling By Invitation

• 2 other identifiers: AZ 156/17DRKS00013589
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

pulmonary hypertension; endtidal co2; endtidal carbon dioxide; pulmonary arterial hypertension

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Establishing a cut-off

  At baseline

Study Arms (1)

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

Interventions

Capnography DIAGNOSTIC_TEST

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

Suspicion of pulmonary hypertension

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• none

Sponsors & Collaborators

• University of Giessen: lead

Study Sites (1)

University Clinic Giessen and Marburg

Giessen, Hesse, 35392, Germany

Location

Related 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.

  PMID: 21622547 BACKGROUND

MeSH Terms

Conditions

Hypertension, Pulmonary; Familial Primary Pulmonary Hypertension; Vascular Diseases; Lung Diseases; Pulmonary Arterial Hypertension

Interventions

Capnography

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Hypertension; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Henning Gall, MD, PhD

  University Clinic Giessen and Marburg - Campus Giessen

  PRINCIPAL INVESTIGATOR

• Werner Seeger, Prof.

  University Clinic Giessen and Marburg

  STUDY DIRECTOR

• Ardeschir Ghofrani, Prof.

  University Clinic Giessen and Marburg

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study Chair: Ghofrani H. Ardeschir, Prof. Dr. University of Giessen

Study Record Dates

• First Submitted: December 22, 2017
• First Posted: January 3, 2018
• Study Start: May 2, 2018
• Primary Completion (Estimated): January 1, 2030
• Study Completion (Estimated): January 1, 2035
• Last Updated: May 19, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)