Aerosol clearance in patients with and without long COVID
| ISRCTN | ISRCTN11309292 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11309292 |
| IRAS number | 313254 |
| Secondary identifying numbers | 3-013-22, IRAS 313254 |
- Submission date
- 08/04/2022
- Registration date
- 01/06/2022
- Last edited
- 11/07/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Plain English Summary
Background and study aims
The goal of this research is to help determine the cause of breathlessness in people who are suffering from long COVID (ongoing symptoms more than 4 weeks since COVID-19 infection). By taking an extra measurement when performing nuclear medicine lung scans it is possible to determine how a part of the lungs called the alveolar epithelial membrane is working. It is known that this membrane can be affected by lung disease and smoking. The main aim of this study is to find out if this membrane is also affected by COVID-19. The study can do this by asking participants extra questions and taking extra pictures.
Who can participate?
Patients aged 18 years and over who have been referred to the Department of Nuclear Medicine, Ninewells Hospital, Dundee for a lung scan as part of their standard of care
What does the study involve?
A radiographer or clinical technologist will discuss the study with potential participants. Staff will ensure any questions are answered. Potential participants will have at least 1 hour to consider taking part in the study. If they decide to take part, staff will ask them to sign a consent form to give their permission after they understand all of the information. If they agree to take part in this study staff will ask them to complete a brief questionnaire before their lung scan. The questionnaire will ask about their smoking habits and the smoking habits of the people they live with. It will also ask about any heart or lung problems they may have had. Only study participants are asked to complete this questionnaire. In the first part of a nuclear medicine lung scan staff ask patients to breathe in an aerosol that contains a small amount of radioactivity. Staff then take pictures of this radioactivity while patients are lying down using a gamma camera. The radiation dose from this procedure is equivalent to around 1 month’s natural background radiation. This is the standard procedure for lung scans and all patients will undergo this whether they choose to take part in this study or not. This study involves taking extra pictures which will take an additional 10 minutes. Participants will be in the same lying down position. There is no additional radiation dose from the extra pictures.
What are the possible benefits and risks of participating?
Information learned from the study may help other people in the future. Nuclear medicine lung scans are part of a participant's routine care. If they take part in this study they will not breathe in any additional radioactivity. This procedure uses ionising radiation to form images of their body and provide their doctor with other clinical information. Ionising radiation may cause cancer many years or decades after the exposure. The chances of this happening to them are the same whether they take part in this study or not. The exam will take 10 minutes longer than if they did not take part in this study.
Where is the study run from?
Ninewells Hospital (UK)
When is the study starting and how long is it expected to run for?
February 2022 to December 2023
Who is funding the study?
NHS Tayside (UK)
Who is the main contact?
Mr Thomas J Biggans
thomas.biggans@nhs.scot
Contact information
Principal Investigator
Nuclear Medicine
Ninewells Hospital
Dundee
DD1 9SY
United Kingdom
 ORCID ID |
0000-0003-4130-5452 |
|---|---|
| Phone | +44 (0)1382 633888 |
| thomas.biggans@nhs.scot |
Scientific
Nuclear Medicine
Ninewells Hospital
Dundee
DD1 9SY
United Kingdom
| ORCID ID |
0000-0003-4130-5452 |
|---|---|
| Phone | +44(0)1382 633888 |
| thomas.biggans@nhs.scot |
Public
Nuclear Medicine
Ninewells Hospital
Dundee
DD1 9SY
United Kingdom
| ORCID ID |
0000-0003-4130-5452 |
|---|---|
| Phone | +44 (0)1382 633888 |
| thomas.biggans@nhs.scot |
Study information
| Study design | Single-centre 1-year observational case-control study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Case-control 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 | A feasibility study to assess alveolar epithelial permeability in smoking and non-smoking control groups and patients suffering ongoing symptoms more than 4 weeks since COVID-19 infection (long COVID) using pulmonary clearance of [99mTc]DTPA aerosol measured by lung scintigraphy |
| Study hypothesis | The clearance rate of [99mTc]DTPA aerosol from the lungs in patients suffering from long COVID is higher than in control groups. |
| Ethics approval(s) | Approved 30/05/2022, North of Scotland Research Ethics Committee (Summerfield House, 2 Eday Road, Aberdeen, AB15 6RE; +44 (0)1224 558458; gram.nosres@nhs.scot), ref: 22/NS/0061 |
| Condition | Long COVID |
| Intervention | Current intervention as of 11/07/2022: Potential participants will be identified from the referral information on the radiology information system (RIS). No other method will be used to identify potential participants. The majority of these exams are considered urgent and often take place within 24 hours of referral. The corresponding recruitment window is therefore short. Potential participants will be given a participant information sheet at the beginning of their appointment. The consent process will consist of discussion between the potential participant and a member of the nuclear medicine technical staff with an opportunity to ask questions. The potential participant will be given at least 1 hour to consider their participation. Informed consent will be recorded in writing using the informed consent form. Trained nuclear medicine technical staff will then administer the study questionnaire. The questionnaire collects data on the smoking habits of the participant and those they live with. It also asks participants about their cardiac and pulmonary clinical history. In line with the local standard clinical protocol, participants will then be positioned on the scanning bed of a gamma camera and then asked to inhale [99mTc]DTPA aerosol. The gamma camera will be used to acquire six images from different angles. In addition to the local standard clinical protocol, a series of 20 more images will be acquired after the initial set. This series will consist of 10 anterior and posterior pairs at a rate of 1 pair per minute. Nothing further is expected of the participant after the second set of images. They will complete the second part of the scan as per the clinical protocol. This part is not included in the study. Regions of interest (ROIs) will be drawn around the lungs on each image and the number of counts within each ROI recorded. This will be recorded along with the time the image was taken. Geometric mean counts will be plotted on a graph against the time the images were taken. Clearance half times will be calculated using this graph. The average of the two lungs will be calculated as the representative value for each participant. Participants will be allocated into one of four patient groups using the referral data from RIS and the questionnaire data. The four groups will be: 1. Non-smoking patients with a clinical history of long COVID 2. Smoking patients with a clinical history of long COVID 3. Non-smoking patients with no history of interstitial lung or airways disease 4. Smoking patients with no history of interstitial lung or airways disease The clearance rates of long COVID and the control group will be compared using the appropriate statistical test. _____ Previous intervention: Potential participants will be identified from the referral information on the radiology information system (RIS). No other method will be used to identify potential participants. The majority of these exams are considered urgent and often take place within 24 hours of referral. The corresponding recruitment window is therefore short. Potential participants will be given a participant information sheet at the beginning of their appointment. The consent process will consist of discussion between the potential participant and a member of the nuclear medicine technical staff with an opportunity to ask questions. The potential participant will be given at least 15 minutes to consider their participation. Informed consent will be recorded in writing using the informed consent form. Trained nuclear medicine technical staff will then administer the study questionnaire. The questionnaire collects data on the smoking habits of the participant and those they live with. It also asks participants about their cardiac and pulmonary clinical history. In line with the local standard clinical protocol, participants will then be positioned on the scanning bed of a gamma camera and then asked to inhale [99mTc]DTPA aerosol. The gamma camera will be used to acquire six images from different angles. In addition to the local standard clinical protocol, a series of 20 more images will be acquired after the initial set. This series will consist of 10 anterior and posterior pairs at a rate of 1 pair per minute. Nothing further is expected of the participant after the second set of images. They will complete the second part of the scan as per the clinical protocol. This part is not included in the study. Regions of interest (ROIs) will be drawn around the lungs on each image and the number of counts within each ROI recorded. This will be recorded along with the time the image was taken. Geometric mean counts will be plotted on a graph against the time the images were taken. Clearance half times will be calculated using this graph. The average of the two lungs will be calculated as the representative value for each participant. Participants will be allocated into one of four patient groups using the referral data from RIS and the questionnaire data. The four groups will be: 1. Non-smoking patients with a clinical history of long COVID 2. Smoking patients with a clinical history of long COVID 3. Non-smoking patients with no history of interstitial lung or airways disease 4. Smoking patients with no history of interstitial lung or airways disease The clearance rates of long COVID and the control group will be compared using the appropriate statistical test. |
| Intervention type | Other |
| Primary outcome measure | The clearance half time of [99mTc]DTPA aerosol from the lungs measured by lung scintigraphy on the day of recruitment in non-smoking patients with a clinical history of long COVID |
| Secondary outcome measures | The clearance half time of [99mTc]DTPA aerosol from the lungs measured by lung scintigraphy on the day of recruitment in: 1. Smoking patients with a clinical history of long COVID 2. Non-smoking patients with no history of interstitial lung or airways disease 3. Smoking patients with no history of interstitial lung or airways disease |
| Overall study start date | 01/02/2022 |
| Overall study end date | 01/12/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 100 |
| Participant inclusion criteria | 1. Patients referred to the Department of Nuclear Medicine, Ninewells Hospital, Dundee for a lung V/Q scan as part of their standard of care 2. Participants must be 18 years old or above |
| Participant exclusion criteria | 1. Below 18 years of age 2. Pregnant 3. Lack of capacity to provide informed consent 4. Involved in current research or have recently been involved in any research prior to recruitment |
| Recruitment start date | 08/07/2022 |
| Recruitment end date | 08/07/2023 |
Locations
Countries of recruitment
- Scotland
- United Kingdom
Study participating centre
Dundee
DD1 9SY
United Kingdom
Sponsor information
Hospital/treatment centre
TASC R&D Office
Residency Block
Ninewells Hospital
George Pirie Way
Dundee
DD1 9SY
Scotland
United Kingdom
| Phone | +44 (0)1382 383877 |
|---|---|
| TASCgovernance@dundee.ac.uk | |
| Website | http://www.nhstayside.scot.nhs.uk/index.htm |
"ROR" |
https://ror.org/000ywep40 |
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | 01/12/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | 1. Ownership of the data arising from this study resides with the study team and their respective employers. On completion of the study, the study data will be analysed and tabulated, and a clinical study report will be prepared. 2. The clinical study report will be used for publication and presentation at scientific meetings. Investigators have the right to publish orally or in writing the results of the study. 3. Summaries of results will also be made available to investigators for dissemination within their clinical areas (where appropriate and according to their discretion). |
| IPD sharing plan | The datasets generated and analysed during the current study are not expected to be made available as participants do not provide consent for data to be shared |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
11/07/2022: The following changes have been made:
1. The recruitment end date has been changed from 01/05/2023 to 08/07/2023.
2. The overall trial end date has been changed from 01/05/2023 to 01/12/2023.
3. The intervention has been changed.
4. The plain English summary has been updated to reflect the above changes.
5. The recruitment start date has been changed from 01/05/2022 to 08/07/2022.
6. The ethics approval has been updated to correct the name and contact details of the REC.
19/04/2022: Trial's existence confirmed by NHS Tayside.
