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RECRUITING
NCT05903001

Diaphragmatic Function as a Biomarker

Sponsor: RWTH Aachen University

View on ClinicalTrials.gov

Summary

Dyspnea is among the most common symptoms in patients with respiratory diseases such as Asthma, chronic obstructive pulmonary disease (COPD), Fibrosis, and Pulmonary Hypertension. However, the pathophysiology and underlying mechanisms of dyspnea in patients with respiratory diseases are still poorly understood. Diaphragm dysfunction might be highly prevalent in patients with dyspnea and respiratory diseases. The association of diaphragm function and potential prognostic significance in patients with respiratory diseases has not yet been investigated.

Official title: Diaphragmatic Function as a Biomarker in Patients With Respiratory Diseases

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

800

Start Date

2023-07-01

Completion Date

2026-12-30

Last Updated

2026-01-28

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

Diaphragm Ultrasound

Ultrasound of the Diaphragm at the end of inspiration and expiration

DIAGNOSTIC_TEST

Intercostal Muscle Ultrasound

Ultrasound of the Intercostal Muscles at the end of inspiration and expiration

DIAGNOSTIC_TEST

Borg scale

Questionnaire for Perceived Exertion (Borg Rating of Perceived Exertion Scale)

DIAGNOSTIC_TEST

MRC Breathlessness Scale

The MRC Dyspnoea Scale allows the patients to indicate the extent to which their breathlessness affects their mobility.

DIAGNOSTIC_TEST

Respiratory Questionaire

Specialized respiratory questionnaire with different domains (Emotional Domain, Dyspnea Domain, Mastery Domain, Fatigue Domain)

DIAGNOSTIC_TEST

GINA classification of Asthma

Patients are classified according to the GINA classification of Asthma.

DIAGNOSTIC_TEST

Measurement of respiratory mouth pressure

Inspiratory and expiratory Measurement of respiratory mouth pressure

DIAGNOSTIC_TEST

SNIP

Measurement of Sniff Nasal Inspiratory Pressure

DIAGNOSTIC_TEST

6-minute walking distance

The maximum walking distance achieved in 6 minutes

DIAGNOSTIC_TEST

60 seconds sit-to-stand test

number of repetitions achieved in sitting down and standing up in 60 seconds

DIAGNOSTIC_TEST

Electromyography

electromyography of the muscles of respiration via superficial electrodes

DIAGNOSTIC_TEST

Lung Function

Measurement of lung function via body plethysmography

DIAGNOSTIC_TEST

CAT-Questionnaire

COPD Assessment Test (CAT)

DIAGNOSTIC_TEST

European Society of Cardiology (ESC)/ European Respiratory Society (ERS) risk group

Patients with pulmonary hypertension are classified according to the ESC/ERS risk group.

Locations (1)

RWTH Aachen University Hospital

Aachen, North Rhine-Westphalia, Germany