Clinical course of COVID-19 patients needing supplemental oxygen outside the intensive care unit.
Ayham Daher, Paul Balfanz, Maria Aetou...
https://pubmed.ncbi.nlm.nih.gov/33500431Actively Recruiting
Age: 18Years +
All Genders
ID05903001
Diaphragmatic Function as a Biomarker in Patients With Respiratory Diseases
Led by RWTH Aachen University · Updated on 2026-01-28
800
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the role of diaphragm function as a biomarker in patients with respiratory diseases such as Asthma, COPD, Fibrosis, and Pulmonary Hypertension. This study aims to better understand the causes of breathlessness (dyspnea) and how diaphragm dysfunction may relate to symptoms and disease outcomes. The research will include up to 800 patients from these four groups to explore the connection between respiratory muscle function and patient health. Participants will undergo comprehensive respiratory muscle testing, including diaphragm and intercostal muscle ultrasounds, lung function tests, exercise tolerance evaluations, and symptom questionnaires during one day at the study center. Follow-up will be conducted primarily by phone at 3, 6, 12, and 18 months after the initial visit. A smaller subgroup of patients starting certain approved drug therapies will have additional in-person follow-ups with repeated non-invasive measurements. Throughout the study, participants will complete various assessments such as dyspnea scales, walking tests, breathlessness ratings, and respiratory questionnaires. Researchers will also monitor hospitalizations and steroid use related to exacerbations to assess the prognostic significance of diaphragm dysfunction. The study includes detailed measurement of respiratory pressures, blood gas analysis, and electromyography, with participation lasting up to 18 months after enrollment.
CONDITIONS
Brief Title
Diaphragmatic Function as a Biomarker
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Patient has one of the following lung diseases: COPD, bronchial asthma, pulmonary fibrosis, or pulmonary hypertension
- Is 18 years or older
- Mentally and physically able to understand the study and follow instructions
- Is legally competent
- Signed declaration of consent
You will not qualify if you...
- Body mass index (BMI) greater than 35
- Current or past treatments or diseases that could influence study evaluation
- Expected lack of willingness to actively participate in study-related measures
- Alcohol or drug abuse
- Disc herniation or prolapse
- Epilepsy
- Wheelchair bound
- In custody due to an official or court order
- Dependent or employment relationship with the investigating physician or deputy
- Emergency inpatient hospital stay within 4 weeks before study examinations
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Diagnostic Evaluation
Duration - 1 day
Participants undergo comprehensive measurements of respiratory muscle function, lung function, exercise tolerance, and symptom burden during one day in the study lab.
1 baseline visit (in-person)
Long-term Monitoring
Duration - 18 months
Participants are followed up by phone at 3, 6, 12, and 18 months after the baseline visit to assess symptom progression and health outcomes. A small subset of participants initiating certain drug therapies will have in-person follow-up visits to repeat diagnostic measurements.
Phone follow-up at 3, 6, 12, and 18 months; in-person visits for a subset depending on therapy
Trial Site Locations
Total: 1 location
1
RWTH Aachen University Hospital
Aachen, North Rhine-Westphalia, Germany, 52074
Actively Recruiting
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Research Team
J
Jens Spiesshoefer, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
4
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Published Research Related To This Trial
Follow up of patients with severe coronavirus disease 2019 (COVID-19): Pulmonary and extrapulmonary disease sequelae.
Ayham Daher, Paul Balfanz, Christian Cornelissen...
https://pubmed.ncbi.nlm.nih.gov/33120193Early risk markers for severe clinical course and fatal outcome in German patients with COVID-19.
Paul Balfanz, Bojan Hartmann, Dirk Müller-Wieland...
https://pubmed.ncbi.nlm.nih.gov/33513168Transdiapragmatic pressure and contractile properties of the diaphragm following magnetic stimulation.
Jens Spiesshoefer, Carolin Henke, Simon Herkenrath...
https://pubmed.ncbi.nlm.nih.gov/31029769Assessment of Central Drive to the Diaphragm by Twitch Interpolation: Normal Values, Theoretical Considerations, and Future Directions.
Jens Spiesshoefer, Carolin Henke, Simon Herkenrath...
https://pubmed.ncbi.nlm.nih.gov/31352459Evaluation of Respiratory Muscle Strength and Diaphragm Ultrasound: Normative Values, Theoretical Considerations, and Practical Recommendations.
Jens Spiesshoefer, Simon Herkenrath, Carolin Henke...
https://pubmed.ncbi.nlm.nih.gov/32396905