Plain English Summary
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
Trial website
Contact information
Type
Public
Primary contact
Prof Richard Newsom
ORCID ID
https://orcid.org/0000-0002-2221-0653
Contact details
Faculty of Science and Health
St. Michael's Building
White Swan Road
Portsmouth
PO1 2DT
United Kingdom
+44 (0)23 9284 2994
richard.newsom@port.ac.uk
Type
Scientific
Additional contact
Prof Richard Newsom
ORCID ID
https://orcid.org/0000-0002-2221-0653
Contact details
Faculty of Science and Health
White Swan Road
Porstmouth
PO1 2DT
United Kingdom
+44 (0)23 9284 2994
richard.newsom@port.ac.uk
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
IRAS 285515
Study information
Scientific title
Oral fluorescein as a biomarker for droplet and aerosol spread of COVID-19 within a clinical environment
Acronym
Study hypothesis
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
Not provided at time of registration
Study design
Multi-centre randomized controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Prevention
Patient information sheet
Not provided at time of registration
Condition
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
Phase
Not Applicable
Drug names
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 trial start date
15/06/2020
Overall trial end date
01/03/2022
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Patients undergoing AGP at Queen Alexandra Hospital
2. Patients in dental faculty University of Portsmouth
3. Aged 18 years or above
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
400
Participant exclusion criteria
1. Not able to consent to the investigation
2. COVID-19 infection, or symptoms
3. Allergy to fluorescein, or multiple allergies
Recruitment start date
01/11/2020
Recruitment end date
01/12/2021
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Queen Alexandra Hospital
Cosham
Portsmouth
PO6 3LY
United Kingdom
Trial participating centre
University of Portsmouth
Winston Churchill Avenue
Portsmouth
PO1 2UP
United Kingdom
Sponsor information
Organisation
University of Portsmouth
Sponsor details
University House
Winston Churchill Avenue
Portsmouth
P01 2UP
United Kingdom
-
simon.kolstoe@port.ac.uk
Sponsor type
University/education
Website
https://www.port.ac.uk/about-us/contact-us
Organisation
Queen Alexandra Hospital
Sponsor details
Cosham
Portsmouth
PO6 3LY
United Kingdom
+44 (0)23 9228 6000
Alice.Mortlock@porthosp.nhs.uk
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Government
Funder name
UK Research and Innovation
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer-reviewed journal.
IPD sharing statement:
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.
Intention to publish date
01/12/2022
Participant level data
Available on request
Basic results (scientific)
Publication list