Reducing the risk of COVID-19 spread in hospitals, by stopping droplets from spreading
| ISRCTN | ISRCTN10378358 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10378358 |
| IRAS number | 285515 |
| Secondary identifying numbers | IRAS 285515 |
- Submission date
- 13/06/2020
- Registration date
- 08/07/2020
- Last edited
- 15/03/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Stopped
- Condition category
- Infections and Infestations
Plain English summary of protocol
Background and study aims
Aerosol Generating Procedures – are a group of procedures that splatter drops into the hospital environment, these droplets can carry COVID-19 in infected patients. Because of this they have been regulated by the NHS, however there is little real data about them. This trial aims to image the droplet and aerosol formation from AGPs and to measure the effect of a simple barrier placed over the AGP, to see whether this reduces the spread of droplets into the hospital environment. If we can prove this to be the case, the NHS will benefit by being able to work in a more efficient / normal manner.
This trial is looking at reducing the effect of Aerosol generating procedures, by draping the patient in a plastic sheet.
Who can participate?
Patients undergoing AGP at Queen Alexandra Hospital and patients in the dental faculty of University of Portsmouth aged 18 years or above.
What does the study involve?
The study involves placing a clear plastic drape over the AGP, and measuring the spread of droplets. Some patients will be randomised to receiving this drape and others will simply have their normal treatment. We will ensure that any drape does not affect the normal care that the patient receives. We will be using a fluorescein dye with special lights and cameras to capture images of the droplets spread from patients undergoing AGPs. We hope to show that simple measures such as using a physical barrier can help in the prevention of spread of these droplets and therefore COVID-19 in hospital.
What are the possible benefits and risks of participating?
The potential benefits are huge for the NHS, if we can get back to working normally and efficiently the individual patients may receive better care and their friends and family too.
Where is the study run from?
The University of Portsmouth (UK)
When is the study starting and how long is it expected to run for?
Who is funding the study?
UK Research and Innovation
Who is the main contact?
Prof. Richard Newsom, richard.newsom@port.ac.uk
Contact information
Public
Faculty of Science and Health
St. Michael's Building
White Swan Road
Portsmouth
PO1 2DT
United Kingdom
 ORCID ID |
0000-0002-2221-0653 |
|---|---|
| Phone | +44 (0)23 9284 2994 |
| richard.newsom@port.ac.uk |
Scientific
Faculty of Science and Health
White Swan Road
Porstmouth
PO1 2DT
United Kingdom
| ORCID ID |
0000-0002-2221-0653 |
|---|---|
| Phone | +44 (0)23 9284 2994 |
| richard.newsom@port.ac.uk |
Study information
| Study design | Multi-centre randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Prevention |
| Participant information sheet | Not provided at time of registration |
| Scientific title | Oral fluorescein as a biomarker for droplet and aerosol spread of COVID-19 within a clinical environment |
| Study objectives | We propose to measure the spread of droplets within high risk clinical procedures called Aerosol Generating Procedures (AGPs). We will measure the droplets and aerosols produced by patients under going treatment and see if we can reduce them with a simple plastic sheet. We will also measure droplet spread on the ward and outpatients. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Patients undergoing AGP |
| Intervention | The researchers will stain the saliva and nasal secretions with Fluorescein 2%, one drop in the mouth and one in each nostril. The AGP will be performed and the spread of the droplets will be gathered from screens set at 1 m distant. These will be angled vertical and horizontal at a height of 1.0m, the aim being to catch a sample of the falling droplets. These will be imaged with hyperspectral and forensic photography but also microscopy to detect minute droplet particles. For each AGP we will measure 30 patients, randomised into two groups: those with no plastic covering and those with a plastic covering with a drape. The dental patients will be randomised to having a dental rubber dam vs no rubber dam. AGPs 1. Intubation and extubating 2. Tracheostomy (insertion or open suction or removal) 3. Bronchoscopy and upper airway procedures 4. Upper gastrointestinal endoscopy 5. Cataract surgery – involving phaco probe 6. Dental procedures involving high-speed drilling/hygiene 7. Non-invasive ventilation e.g. Continuous positive pressure ventilation 8. Induction of sputum 9. High flow nasal oxygen |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Plastic sheet 2 x 3 m |
| Primary outcome measure | The proportion of patients where the spread of airborne droplets during AGP is > 50 drops on a detection pad at 1 m |
| Secondary outcome measures | none |
| Overall study start date | 15/06/2020 |
| Completion date | 01/03/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 400 |
| Key inclusion criteria | 1. Patients undergoing AGP at Queen Alexandra Hospital 2. Patients in dental faculty University of Portsmouth 3. Aged 18 years or above |
| Key exclusion criteria | 1. Not able to consent to the investigation 2. COVID-19 infection, or symptoms 3. Allergy to fluorescein, or multiple allergies |
| Date of first enrolment | 01/11/2020 |
| Date of final enrolment | 01/12/2021 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Portsmouth
PO6 3LY
United Kingdom
Portsmouth
PO1 2UP
United Kingdom
Sponsor information
University/education
University House
Winston Churchill Avenue
Portsmouth
P01 2UP
United Kingdom
| simon.kolstoe@port.ac.uk | |
| Website | https://www.port.ac.uk/about-us/contact-us |
"ROR" |
https://ror.org/03ykbk197 |
Hospital/treatment centre
Cosham
Portsmouth
PO6 3LY
England
United Kingdom
| Phone | +44 (0)23 9228 6000 |
|---|---|
| Alice.Mortlock@porthosp.nhs.uk | |
| Website | http://www.porthosp.nhs.uk/ |
|
"ROR" |
https://ror.org/04rha3g10 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- UKRI
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 01/12/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request. Request to richard.newsom@port.ac.uk – from website: https://researchportal.port.ac.uk/portal/ - for ten years – no personal patient data will be retained, but consent will be taken. |
Editorial Notes
15/03/2022: The study was stopped as ethics approval was not granted.
14/09/2020: The recruitment start date was changed from 01/09/2020 to 01/11/2020.
15/06/2020: Trial’s existence confirmed by University of Portsmouth
