Comparing devices for measuring lung function in systemic sclerosis
Comparison Between Two Commercially Available Devices to Measure Nitric Oxide Lung Diffusing Capacity in Systemic Sclerosis: a Randomized Crossover Trial
This study is testing two different devices that measure lung function in people with systemic sclerosis to see how their results compare.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 23 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Zurich Academic / other |
| Locations | 1 site (Zürich, Zurich) |
| Trial ID | NCT05505617 on ClinicalTrials.gov |
What this trial studies
This observational study aims to compare two commercially available devices that measure nitric oxide lung diffusing capacity (DLNO) in patients with systemic sclerosis and interstitial lung disease. Participants will undergo single-breath DLNO measurements using both devices in a random order to assess the differences in outcomes. The study seeks to understand the extent of variability between these devices in individuals with lung function impairment. This research is crucial for improving diagnostic accuracy and treatment monitoring in systemic sclerosis patients.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with a confirmed diagnosis of systemic sclerosis and interstitial lung disease.
Not a fit: Patients with unstable clinical conditions affecting lung function or those who are pregnant may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the accuracy of lung function assessments in patients with systemic sclerosis, leading to better management of their condition.
How similar studies have performed: Previous studies have shown systematic differences in lung diffusing capacity outcomes between devices in healthy individuals, but this specific comparison in systemic sclerosis is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Confirmed diagnosis of systemic sclerosis by American College of Rheumatology/ European League Against Rheumatism (ACR/EULAR1) criteria (≥ 9 points) * Interstitial lung disease proven with high-resolution computed tomography (HRCT) * Written informed consent * Age ≥ 18 years Exclusion Criteria: * Unstable clinical condition affecting lung function testing (i.e., major hemoptoe/-tysis or pneumothorax within the last 3 months, acute respiratory tract infection in the past two weeks), others according to the assessment of the treating physician * Pregnancy
Where this trial is running
Zürich, Zurich
- University of Zurich — Zürich, Zurich, Switzerland (Recruiting)
Study contacts
- Principal investigator: Holger Dressel, Prof — University of Zurich
- Study coordinator: Thomas Radtke, PhD
- Email: thomas.radtke@uzh.ch
- Phone: +41 44 634 63 82
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.