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| Name | Class |
|---|---|
| Lindenhofspital | UNKNOWN |
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Retrospective cohort study using routinely collected annual data on lung clearance index (LCI) in combination with clinical data to predict survival in patients with Cystic Fibrosis. The primary study endpoint is the association of LCI with the compound outcome survival or lung transplantation in patients with CF.
Retrospective analysis of longitudinal data collected during clinically routine from approximately 200 patients with CF aged 3 years or more between 01.01.1980 and 31.12.2005. The overall aim of this project is to retrospectively assess whether LCI measured for clinical purposes during school age is predictive for survival or lung transplantation in adulthood. For this, the investigators will assess in a systematic way clinically measured LCI and relate them with the compound outcome survival or lung transplantation retrospectively.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lung function testing | Diagnostic Test | Multiple-breath washout (MBW) is a safe, easy and sensitive lung function test using inert gases such as Nitrogen (N2) to assess efficiency of ventilation distribution. The latter can be estimated by the lung clearance index (LCI), an established study end-point in patients with CF |
|
| Measure | Description | Time Frame |
|---|---|---|
| Lung clearance index (LCI) | Lung function outcome derived by MBW and the compound Outcomes mortality or lung transplantation | Lung function is collected quarterly until outcome (death or lung transplantation) or end of Study (12/2005) is reached |
| Measure | Description | Time Frame |
|---|---|---|
| Functional residual capacity (FRC) | Lung function outcome derived by MBW | Lung function is collected quarterly until outcome (death or lung transplantation) or end of Study (12/2005) is reached |
| Forced expired Volume in 1 second (FEV1) |
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Inclusion Criteria:
Exclusion Criteria:
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Non-Probability sample
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| Name | Affiliation | Role |
|---|---|---|
| Florian Singer | Insel Gruppe AG, University Hospital Bern | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Children's Hospital Bern | Bern | 3007 | Switzerland | |||
| Lindenhof Spital, Quartier Bleu |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34289977 | Derived | Kurz JM, Ramsey KA, Rodriguez R, Spycher B, Fischer Biner R, Latzin P, Singer F. Association of lung clearance index with survival in individuals with cystic fibrosis. Eur Respir J. 2022 Mar 3;59(3):2100432. doi: 10.1183/13993003.00432-2021. Print 2022 Mar. |
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IPD will be shared with researchers involved in the data collection and analysis.
Until 12/2020
Researchers involved in data collection
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| ID | Term |
|---|---|
| D003550 | Cystic Fibrosis |
| D003643 | Death |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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Lung function outcome derived by Spirometry
| Lung function is collected quarterly until outcome (death or lung transplantation) or end of Study (12/2005) is reached |
| Body weight | Anthropometric characteristics | Characteristics are collected quarterly until outcome (death or lung transplantation) or end of Study (12/2005) is reached |
| Body length | Anthropometric characteristics | Characteristics are collected quarterly until outcome (death or lung transplantation) or end of Study (12/2005) is reached |
| Gender | Anthropometric characteristics | Characteristics are collected quarterly until outcome (death or lung transplantation) or end of Study (12/2005) is reached |
| Presence of Pseudomonas aeruginosa infection | Clinical characteristics | Characteristics are collected quarterly until outcome (death or lung transplantation) or end of Study (12/2005) is reached |
| Presence of Staphylococcus aureus infection | Clinical characteristics | Characteristics are collected quarterly until outcome (death or lung transplantation) or end of Study (12/2005) is reached |
| Bern |
| 3012 |
| Switzerland |
| D030342 |
| Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |