The use of dynamic X-rays for patients with respiratory disease
| ISRCTN | ISRCTN14507847 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14507847 |
| IRAS number | 269685 |
| Secondary identifying numbers | IRAS 369685 |
- Submission date
- 26/09/2019
- Registration date
- 13/12/2023
- Last edited
- 20/02/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Plain English Summary
Background and study aims
A chest X-ray is often the first test patients with breathlessness have. It can often be normal if the patient has a disease that affects the way the lungs ‘move’ rather than ‘look’. Information about breathing requires additional breathing tests.
The aim of this study is to investigate the use of new X-ray technology, ‘Dynamic Chest Radiography’ (DCR) that allows several X-rays to be taken while a patient breathes. This provides a ‘film’ showing the way that patients’ chests move while they breathe in addition to the ‘snap-shot’ information that a conventional chest X-ray provides about how their lungs, heart and rib cages ‘look’. DCR can therefore provide a combination of information about both the structure of the lungs and how air is moving through the airways during breathing.
Who can participate?
We are looking for three groups of patients with diseases that affect the way they breathe (patients with COPD, asthma and interstitial lung disease) attending specialist clinics. Study participants are required to have DCR in addition to the pre-arranged detailed breathing test results their doctor has requested.
What does the study involve?
The test (DCR) involves a patient standing in front of an X-ray machine for 10 seconds while taking normal and then deep breaths. The process is then repeated with the patient standing side-on to the X-ray machine. Participants will be asked to complete a visual scale after the test to see how acceptable it is to them. The information from the DCR images will be compared with the detailed breathing tests to see how well the information gained matches.
What are the possible benefits and risks of participating?
There are no specific benefits to individuals from participating in the study, however they will be contributing to the development of a new imaging investigation that we hope will improve the management of future patients.
With regards to safety, DCR uses the same technology as a conventional chest X-ray but allows many more X-rays to be taken with a slight increase in radiation dose. Taking the DCR images for this study involves a small radiation dose which is the equivalent of around 4 week’s additional background radiation exposure. This is significantly less than a CT scan, the test requested by respiratory specialists for patients with these diseases.
Where is the study run from?
Royal Liverpool and Broadgreen University Hospital (UK)
When is the study starting and how long is it expected to run for?
November 2019 to November 2022
Who is funding the study?
Respiratory Research Group, Royal Liverpool University Hospital (UK)
Who is the main contact?
Dr Rachel Burton, Rachel.Burton3@liverpoolft.nhs.uk
Contact information
Scientific, Principal Investigator
-
Liverpool
-
United Kingdom
| Phone | +44 (0)151 706 3381 |
|---|---|
| Hassan.burhan@liverpoolft.nhs.uk |
Scientific
Respiratory Research
9D Office
Royal Liverpool University Hospital
Mount Vernon Street
Liverpool
L7 8YE
United Kingdom
 ORCID ID |
0009-0000-1849-5070 |
|---|---|
| Phone | +44 (0)151 706 3381 |
| Rachel.Burton3@liverpoolft.nhs.uk |
Study information
| Study design | Pilot study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Dynamic chest radiography in patients with asthma, COPD, COVID-19 and ILD: a pilot study |
| Study acronym | DACI |
| Study hypothesis | 1. Dynamic chest radiography (DCR) is an acceptable investigation to patients with Asthma, COPD and ILD 2. It is feasible to run a DCR study at our centre 3. There is a correlation between the values obtained from DCR and pulmonary function testing in patients with asthma, COPD and ILD |
| Ethics approval(s) | Approved 17/02/2020, West Midlands - Black Country Research Ethics Committee (The Old Chapel, Royal Standard Place, Nottingham, NG1 6FS, UK; +44 (0)207 104 8284; blackcountry.rec@hra.nhs.uk), ref: 20/WM/0032 |
| Condition | Asthma, chronic obstructive pulmonary disease (COPD), interstitial lung disease (ILD) and post-COVID-19 infection |
| Intervention | Four groups of patients will be identified from those attending the respiratory outpatient clinic: those with asthma, COPD, ILD and post-COVID-19 infection. Patients will be due to have full pulmonary function tests (PFTs) in order to be eligible for this study. A dynamic chest X-ray will be organised to take place within 6 months of their scheduled pulmonary function tests. Women of childbearing age will be required to have a pregnancy test prior to participation. The dynamic X-ray requires two separate images; a posterio-anterior image and a lateral view. Patients will be asked to breathe normally and then take a deeper breath over a 10-second period (following a standardised protocol) while these images are acquired. During the imaging process the time to obtain analysable imaging sequences will be recorded. A separate breath-hold protocol (participants asked to take a deep breath in and hold for 7 seconds before breathing out) was performed on a subset of the post-COVID-19 infection group. After having the dynamic chest X-ray participants will be asked to complete a visual analogue scale asking how they found the imaging process. |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Dynamic chest radiography |
| Primary outcome measure | Patient acceptability score as measured by a Visual analogue scale (VAS) completed by participants post dynamic chest X-ray |
| Secondary outcome measures | 1. Number of patients recruited to the study recorded per month 2. Number of days from patient consent to performing DCR, recorded post-dynamic chest X-ray 3. Time (in minutes) required for DCR imaging process (defined as time from arrival at DCR suite to image acquisition) completed post-dynamic chest X-ray 4. Lung volume measurements (in Litres) as derived by dynamic chest radiography (Maximal Inspiratory Volume (MIV), End Expiratory Volume (EEV), Vital Capacity (MIV-EEV)) measured at the point of dynamic chest imaging 5. Lung volume measurements (total lung capacity (TLC), residual volume (RV), forced vital capacity (FVC), residual volume (RV)) in litres recorded at the point of pulmonary function testing |
| Overall study start date | 01/03/2019 |
| Overall study end date | 01/11/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 50 |
| Total final enrolment | 58 |
| Participant inclusion criteria | 1. Undergoing PFTs in the next 6 months for clinical reasons 2. Asthma group: 2.1. A clinical history in keeping with asthma 2.2. Physiological evidence of asthma (defined as post bronchodilator reversibility, variable FEV1 over time or a previous positive bronchial challenge test) 3. COPD group: 3.1. A clinical history in keeping with COPD 3.2. Physiological evidence of COPD (FEV1/FVC ratio of <0.7) 4. ILD group: 4.1. A clinical history in keeping with ILD 4.2. HRCT findings in keeping with ILD 5. Post-COVID-19 group: 5.1. Serologically confirmed COVID-19 infection 5.2. Chest X-ray or CT findings in keeping with COVID-19 5.3. At least 12 weeks post-recovery from acute COVID-19 6. Fluent spoken English - to ensure a comprehensive understanding of the research project and their proposed involvement 7. Able to achieve positioning for a PA and lateral chest X-ray for a 30-second period |
| Participant exclusion criteria | 1. Unable to provide informed consent 2. Significant other respiratory co-morbidities as judged by study doctor 3. Recent/ongoing exacerbation of airways disease or interstitial lung disease within the last 4 weeks (from the recruitment date). 4. Women of child bearing age; a positive pregnancy test or refusal of pregnancy test (a negative pregnancy test on the day of DCR is a requirement). 5. Significant research-related radiation exposure in the last 12 months prior to consent (from participation in previous studies involving radiation exposure, with a research dose constraint of 0.4 mSv). |
| Recruitment start date | 01/12/2020 |
| Recruitment end date | 01/11/2022 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Prescot street
Liverpool
L7 8XP
United Kingdom
Sponsor information
Hospital/treatment centre
Prescot Street
Liverpool
L7 8XP
England
United Kingdom
| Phone | +44 (0)151 7062000 |
|---|---|
| rgt@rlbuht.nhs.uk | |
| Website | https://www.rlbuht.nhs.uk/our-hospitals/royal-liverpool-university-hospital/ |
"ROR" |
https://ror.org/01ycr6b80 |
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | 26/11/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Results of the trial will be published in a peer-reviewed journal following completion |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request: Rachel Burton (Rachel.Burton3@liverpoolft.nhs.uk) |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 10/02/2025 | 20/02/2025 | Yes | No |
Editorial Notes
20/02/2025: Publication reference added.
29/11/2024: The intention to publish date was changed from 01/08/2024 to 26/11/2024.
14/05/2024: The intention to publish date was changed from 01/05/2024 to 01/08/2024.
29/02/2024: Contact details updated.
13/02/2024: A scientific contact has been added.
21/09/2021: Trial's existence confirmed by West Midlands - Black Country Research Ethics Committee.
