sing dynamic chest x-ray to understand the lungs of individuals with cystic fibrosis

Not Applicable

Completed

• Conditions: Cystic fibrosis; Nutritional, Metabolic, Endocrine

• Registration Number: ISRCTN64994816
• Lead Sponsor: iverpool Heart and Chest Hospital

Brief Summary

2020 Protocol article in https://pubmed.ncbi.nlm.nih.gov/32217535 protocol (added 30/03/2020) 2022 Results article in https://doi.org/10.1148/radiol.212641 (added 15/03/2022) 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37147023/ Feasibility results (added 09/05/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-12-05
• Study Completion: 2020-11-01
• Last Update Posted: 22 May 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 154

Inclusion Criteria

1. Age = 17 years old
2. Attending the adult CF Unit at LHCH
3. Confirmed CF diagnosis (positive sweat test in childhood and by genotyping)
4. Able to provide informed consent

Exclusion Criteria

1. Potentially pregnant or lactating
2. Refusal or inability to provide informed consent
3. Unable or unwilling to sit or stand to perform DCR in the radiology department
4. Unable or unwilling to follow tidal breathing instructions (e.g., holding breath or taking a deep breath)
5. Unable to perform reproducible spirometry and/or full pulmonary function studies within ATS-ERS criteria
6. Any serious or active medical or psychiatric illness, which in the opinion of the investigators, would interfere with subject treatment, assessment, or compliance with the protocol
7. For those in the validation part of the study: suffering an acute exacerbation of underlying CF
8. For those in the validation part of the study: known to be MRSA positive
9. For those in the validation or exacerbation parts of the study: significant radiation exposure within the last year (for example, numerous CT scans of chest)
10. Involved, either currently or recently, in other studies involving non-routine exposure to sources of ionising radiation

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Lung function (in the form of diaphragmatic movement) and lung volume measured by dynamic chest radiography<br>2. Lung function (provided by spirometry or pulmonary function studies)<br>3. Lung volume (provided by body plethysmography). <br><br>This information will be gathered at the time of data collection (i.e. retrospective analysis of Annual Screen dynamic chest radiographs, which already form part of standard care at our Trust) or during collection of dynamic chest radiographs. There is no follow-up of patients required, so as soon as dynamic radiographs are taken for the patients, data analysis can be performed.

Secondary Outcome Measures

Name	Time	Method
1. Microbial colonisation measured using patient records<br>2. The presence of CF-related diabetes (CFRD) measured using patient records<br>3. Height, weight and BMI measured using patient records