Studying aerosol emission of the COVID-19 virus in healthcare settings
| ISRCTN | ISRCTN21447815 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN21447815 |
| IRAS number | 288784 |
| Secondary identifying numbers | 3.4, IRAS 288784, CPMS 47097 |
- Submission date
- 01/10/2020
- Registration date
- 16/10/2020
- Last edited
- 16/12/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Plain English summary of protocol
Background and study aims
Aerosol generation occurs when tiny droplets of liquid are suspended in the air. Aerosols can be generated during many medical procedures. Some procedures might produce more aerosols than others, and droplets of different sizes, but this is largely unknown at the moment. However, aerosols can carry viruses, like coronavirus, which risks further infections if inhaled by healthcare staff or other patients. This study aims to determine how aerosol is produced in healthcare settings and how it settles and disperses. This is critical, as it is increasingly recognised that COVID-19 can spread via aerosol. Many healthcare procedures (such as intubation) are considered potentially ‘aerosol-generating’, which means healthcare workers have to wear personal protective equipment (PPE) and there are delays in procedures. This study aims to measure whether and how much aerosol is actually generated in these procedures, how long it takes to settles, and whether it is possible to mitigate the risk of aerosol spread in hospitals. This will aim to inform whether the PPE worn during these procedures is correct, and what can be done to try and limit risk to staff and patients of aerosol transmission of coronavirus. This study will be performed in hospitals, specifically at North Bristol NHS Trust and University Hospital Bristol and Weston NHS Foundation trust, using equipment from the School of Chemistry at the Bristol Aerosol Research Centre to measure aerosol.
Who can participate?
People will be recruited from two sources: patients who are undergoing procedures as part of routine care in hospitals already, and healthy volunteers. Healthy volunteers must be adults (>18) and must not have COVID-19 symptoms.
What does the study involve?
The study involves measurement of aerosol using small machines, about the size of a computer, attached to funnels that will measure aerosol in the air near participants. Routine data such as age, sex, and BMI will be recorded. No follow up will be arranged, and no other medical procedures will be performed.
What are the possible benefits and risks of participating?
There are no potential benefits of entering, apart from helping the researchers. There are no anticipated negative effects or side effects.
Where is the study run from?
The study is a collaboration between North Bristol NHS Trust, the University of Bristol, and University Hospital Bristol and Weston NHS Foundation Trust (UK)
When is the study starting and how long is it expected to run for?
September 2020 to September 2021
Who is funding the study?
National Institute for Health Research and the UK Research Institutes (NIHR-UKRI) (UK)
Who is the main contact?
Fergus Hamilton
Fergus.hamilton@nbt.nhs.uk
Contact information
Scientific
Infection Science
Pathology Services
Southmead Hospital
Bristol
BS10 5NB
United Kingdom
 ORCID ID |
0000-0002-9760-4059 |
|---|---|
| Phone | +44 (0)7743165499 |
| fergus.hamilton@nbt.nhs.uk |
Public
Infection Science
Pathology Services
Southmead Hospital
Bristol
BS10 5NB
United Kingdom
| ORCID ID |
0000-0002-9760-4059 |
|---|---|
| Phone | +44 (0)07743165499 |
| fergus.hamilton@nbt.nhs.uk |
Study information
| Study design | Aerosol and environmental sampling study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Aerosol and environmental sampling study |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | AERosolisation And Transmission Of SARS-CoV-2 in Healthcare Settings (AERATOR) |
| Study acronym | AERATOR |
| Study objectives | The aim of this study is to quantify the flux, concentration, size distribution, and persistence of aerosol generated by a diverse set of clinical procedures across various settings, and assess heterogeneity between operator, equipment, and room. |
| Ethics approval(s) | Approved 18/09/2020, North West Greater Manchester Central REC (Third Floor, Barlow House, Minshull Street, M1 3DZ, UK; +44 (0)207 104 8193, +44 (0)207 104 8007, +44 (0)207 104 8208; gmcentral.rec@hra.nhs.uk), REC ref: 20/NW/0393 |
| Health condition(s) or problem(s) studied | COVID-19 (SARS-CoV-2 infection) |
| Intervention | The AERATOR study will be carried out using specialist equipment in operating theatres and wards to measure real-life aerosol generation in five clinical settings: dental, orthopaedic, respiratory, critical care and ophthalmology. By using specialist equipment, only available at the University of Bristol, the research team will also investigate how long coronavirus survives while airborne and how environmental conditions impact on the infectivity of the virus. The research will also advise guidelines on the appropriate level of PPE for staff, as well as the length of time the aerosol is present for and how it spreads in a real-world clinical setting. The total duration of observation for each participant is around 15 minutes to 1 hour. The trial will run for 1 year. |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure | 1. Distribution of aerosol produced during routine or simulated procedures measured using Aerodynamic Particle Sensors during the procedure, and for up to 10 minutes after 2. Distribution of aerosol produced during routine or simulated procedures measured using Optical Particle Sensors during the procedure, and for up to 10 minutes after |
| Secondary outcome measures | Distribution of aerosol produced and dissemination measured with Aerodynamic and Optical Particle sensors across a clinical room during procedures and for up to 1 hour after |
| Overall study start date | 19/09/2020 |
| Completion date | 19/09/2021 |
Eligibility
| Participant type(s) | Mixed |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 600 |
| Key inclusion criteria | Patients: 1. Undergoing procedure that is potentially aerosol-generating 2. Aged over 18 3. Have capacity Healthy volunteers: 1. Have capacity to consent to the study 2. Aged over 18 |
| Key exclusion criteria | Patients: 1. Unable to read/understand PIS (either printed version or via translator) 2. Unable to consent Healthy volunteers: 1. Flu-like symptoms (fevers, temperature, new cough, sore throat, loss of smell, breathing difficulties) in the 48 hours prior to study enrolment 2. Clinical contraindication to the procedure being performed |
| Date of first enrolment | 19/09/2020 |
| Date of final enrolment | 19/09/2021 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Southmead Road
Westbury-on-Trym
Bristol
BS10 5NB
United Kingdom
Bristol
BS2 8HW
United Kingdom
Sponsor information
Hospital/treatment centre
Learning and Research Building
Level 3
Southmead Hospital
Bristol
BS10 5NB
England
United Kingdom
| Phone | +44 (0)117950505 |
|---|---|
| researchsponsor@nbt.nhs.uk | |
| Website | http://www.nbt.nhs.uk/ |
"ROR" |
https://ror.org/036x6gt55 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
No information available
Results and Publications
| Intention to publish date | 01/01/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. All articles will be disseminated rapidly to key stakeholders, and where possible, via pre-print servers. |
| IPD sharing plan | Trial-level data will be held at the Bristol Aerosol Research Centre, as this will simply be aerosol measurements attached to the age, sex, and BMI. The researchers are unable to share patient-level data due to sponsor-level agreements around sharing trial data. Interested parties can contact Fergus Hamilton (fergus.hamilton@bristol.ac.uk) to discuss further. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Preprint results | non-peer-reviewed aerosol emission results in preprint | 01/02/2021 | 19/03/2021 | No | No |
| Results article | manual facemask ventilation quantitative evaluation | 26/10/2021 | 27/10/2021 | Yes | No |
| Preprint results | tracheal intubation and extubation sequences quantitative evaluation in preprint | 14/12/2021 | 16/12/2021 | No | No |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
16/12/2021: Preprint reference added.
27/10/2021: Publication reference added.
19/03/2021: Preprint reference added.
01/10/2020: Trial's existence confirmed by the NIHR.
