Condition category
Infections and Infestations
Date applied
13/06/2020
Date assigned
08/07/2020
Last edited
14/09/2020
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Not yet recruiting

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

http://www.porthosp.nhs.uk/

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

Publication citations

Additional files

Editorial Notes

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