Diaphragmatic Function as a Biomarker

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.

Conditions

• Dyspnea; Asthmatic
• COPD
• Fibrosis
• Pulmonary Hypertension
• Asthma
• Dyspnea

Interventions

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Diaphragm Ultrasound

Ultrasound of the Diaphragm at the end of inspiration and expiration

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Intercostal Muscle Ultrasound

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

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Borg scale

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

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MRC Breathlessness Scale

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

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Respiratory Questionaire

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

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GINA classification of Asthma

Patients are classified according to the GINA classification of Asthma.

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Measurement of respiratory mouth pressure

Inspiratory and expiratory Measurement of respiratory mouth pressure

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SNIP

Measurement of Sniff Nasal Inspiratory Pressure

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6-minute walking distance

The maximum walking distance achieved in 6 minutes

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60 seconds sit-to-stand test

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

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Electromyography

electromyography of the muscles of respiration via superficial electrodes

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Lung Function

Measurement of lung function via body plethysmography

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CAT-Questionnaire

COPD Assessment Test (CAT)

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

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

Sponsors & Collaborators

• RWTH Aachen University

  lead OTHER

Principal Investigators

• Michael Dreher, MD · Uniklinik RWTH Aachen

• Binaya Regmi, MD · Uniklinik RWTH Aachen

• Jens Spiesshoefer, MD · Uniklinik RWTH Aachen

• Mustafa Elfeturi · Uniklinik RWTH Aachen

• Benedikt Jörn · Uniklinik RWTH Aachen

• Faniry Ratsimba · Uniklinik RWTH Aachen

• Felix Wagner · Uniklinik RWTH Aachen

• Maria Aetou, Dr. med. · RWTH Aachen University Hospital

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-07-01

Primary Completion

2026-12-30

Completion

2026-12-30

Countries

• Germany

Study Locations