Chronic Lung Allograft Dysfunction, Lung Transplantation, Rejection Lung Transplant
Conditions
Brief summary
The aim of this project is to evaluate the ability of the lung clearance index (LCI) to detect early chronic lung allograft failure (CLAD) in adult lung transplant recipients over a period of 3 years.
Detailed description
This single center study consists of three parts: 1. Characterisation of the Zurich lung transplant cohort regarding CLAD status and pulmonary function impairment (cross-sectional, study part I) 2. Evaluation of test-retest reliability of LCI in 20 clinically stable lung transplant recipients during three consecutive study visits (study part II) 3. Prospective cohort study to test the ability of LCI to detect early CLAD in patients without prior CLAD (study part III)
Interventions
OTHEREarly detection of CLAD by Lung Clearance Index (LCI)
Lung transplant candidates without prior CLAD (evaluated in study part I) will be followed over a period of 3 years to evaluate the potential of LCI to detect early CLAD
Sponsors
University of Zurich
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male and female lung transplant recipients * Written informed consent by the participant after information about the research project
Exclusion criteria
* Any contraindication to perform pulmonary function tests (e.g., persistent pneumothorax) * Acute airway infection * Chronic infection due to Burkholderia spp and nontuberculosis mykobacteria NTM
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in lung clearance index (LCI) | Change from baseline up to 3 years | Measured by multiple breath nitrogen washout (Exhalyzer® D; Eco Medics AG) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in DLNO/DLCO ratio | Change from baseline up to 3 years | Single-breath measurements (Jaeger MasterScreenTM PFT system) |
| Change in slope of acinar airways (Sacin) | Change from baseline up to 3 years | Measured by multiple breath nitrogen washout (Exhalyzer® D; Eco Medics AG) |
| Change in slope of conducting airways (Scond) | Change from baseline up to 3 years | Measured by multiple breath nitrogen washout (Exhalyzer® D; Eco Medics AG) |
| Change in forced expiratory volume in 1s (FEV1) | Change from baseline up to 3 years | Measured by Spirometry (Geratherm Respiratory GmbH) |
| Change in transfer coefficient for nitric oxide (DLNO/VA) | Change from baseline up to 3 years | Single-breath measurements (Jaeger MasterScreenTM PFT system) |
| Change in transfer coefficient for carbon monoxide (DLCO/VA) | Change from baseline up to 3 years | Single-breath measurements (Jaeger MasterScreenTM PFT system) |
| Change in diffusing capacity for carbon monoxide oxide (DLCO) | Change from baseline up to 3 years | Single-breath measurements (Jaeger MasterScreenTM PFT system) |
| Change in forced expiratory flows at 25-75 of vital capacity (FEF25-75) | Change from baseline up to 3 years | Measured by Spirometry (Geratherm Respiratory GmbH) |
| Change in total lung capacity (TLC) | Change from baseline up to 3 years | Measured by Bodyplethysmography (Geratherm Respiratory GmbH) |
| Change in residual volume (RV) | Change from baseline up to 3 years | Measured by Bodyplethysmography (Geratherm Respiratory GmbH) |
| Change in total lung capacity (TLC) / residual volume (RV) ratio | Change from baseline up to 3 years | Measured by Bodyplethysmography (Geratherm Respiratory GmbH) |
| Change in diffusing capacity for nitric oxide (DLNO) | Change from baseline up to 3 years | Single-breath measurements (Jaeger MasterScreenTM PFT system) |
| Change in computed tomography score | Change from baseline up to 3 years | Measured by Computed Tomography: Semiquantative score (i.e., Brody Score); Subscores including bronchiectasis, mucus plugging, airway wall thickening, consolidation, mosaic pattern and air trapping). Subscores will be expressed as the percentage of the maximum score on a scale of 0 (no disease) to 100 (maximal lung disease). |
| Change in forced vital capacity (FVC) | Change from baseline up to 3 years | Measured by Spirometry (Geratherm Respiratory GmbH) |
Outcome results
None listed