HealthyNCT04741217
Aerosolisation During Respiratory Procedures
An observational study of Healthy and Respiratory Tract Infections, run by Guy's and St Thomas' NHS Foundation Trust.
Trial summary
Currently, a major issue within respiratory medicine is undertaking procedures that generate aerosolisation with the concern of spreading infection, such as the SARS-COV-2/COVID-19 virus. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Healthy, Respiratory Tract Infections, Lung Infection
- What is being tested?
- Not an interventional study
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2021to 1 Sep 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Adult, Older adult
Study population: Healthy subjects
Who may be able to join
- Age 18-80 years
- Healthy subjects with no active medical conditions or previous pneumothorax
- Cognitively and linguistically able to follow instructions given in English and provide informed consent
Who cannot join
- Significant respiratory, cardiac or neurological conditions or previous pneumothorax
- Smoking history greater than 10 pack years
- Acute illness at the time of assessment
- Allergies to latex, metals or local anaesthetic agents
About this study
Official title: A Proof of Concept Study to Evaluate Aerosol Generation During Non-Invasive Positive Pressure Respiratory Procedures
Currently, a major issue within respiratory medicine is undertaking procedures that generate aerosolisation with the concern of spreading infection, such as the SARS-COV-2/COVID-19 virus. It is anecdotally reported that lung function testing and positive airways pressure devices used in clinical practice are aerosol generating procedures however the data to support this is limited. With the advent of high-speed imaging systems that can capture and quantify particle size and velocity we aim to investigate the aerosol generation in routine non-invasive positive pressure respiratory procedures.
- Conditions
- Healthy, Respiratory Tract Infections, Lung Infection, Droplet Spread
- Being tested
- Not an interventional study
- Medical subject headings
- Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Not an interventional studyOther
No interventions are implemented. This is an observational study of respiratory droplet aerosolisation during respiratory procedures.
What is being measured
The primary outcome is the main question the study is designed to answer.
Characterisation of aerosolised respiratory droplets
Performed using high-speed imaging and particle size counters
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2021
- Study start1 Mar 2021 (estimated)
- Primary completion1 Sep 2021 (estimated)
- Study completion1 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04741217
- Sponsor's protocol ID
- 288629
- Status last verified
- Aug 2020
- First submitted
- 3 Feb 2021
- Last updated
- 15 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Anonymised data may be shared based upon consideration of reasonable requests from researchers with a stated objective.
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Proof of Concept Study to Evaluate Aerosol Generation During Non-Invasive Positive Pressure Respiratory Procedures
- ClinicalTrials.gov ID
- NCT04741217
- Acronym / sponsor ID
- 288629
- Conditions
- Healthy, Respiratory Tract Infections, Lung Infection, Droplet Spread
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Guy's and St Thomas' NHS Foundation TrustUniversity, hospital or other
- Study start
- 1 Mar 2021 (estimated)
- Primary completion
- 1 Sep 2021 (estimated)
- Study completion
- 1 Sep 2021 (estimated)
- First posted
- 5 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Currently, a major issue within respiratory medicine is undertaking procedures that generate aerosolisation with the concern of spreading infection, such as the SARS-COV-2/COVID-19 virus. It is anecdotally reported that lung function testing and positive airways pressure devices used in clinical practice are aerosol generating procedures however the data to support this is limited. With the advent of high-speed imaging systems that can capture and quantify particle size and velocity we aim to investigate the aerosol generation in routine non-invasive positive pressure respiratory procedures.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Healthy subjects
Key inclusion criteria (3 listed)
- Age 18-80 years
- Healthy subjects with no active medical conditions or previous pneumothorax
- Cognitively and linguistically able to follow instructions given in English and provide informed consent
Key exclusion criteria (4 listed)
- Significant respiratory, cardiac or neurological conditions or previous pneumothorax
- Smoking history greater than 10 pack years
- Acute illness at the time of assessment
- Allergies to latex, metals or local anaesthetic agents
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Not an interventional studyNo interventions are implemented. This is an observational study of respiratory droplet aerosolisation during respiratory procedures. | Other | – |
Primary outcome
Characterisation of aerosolised respiratory droplets
Time frame: 1 year
Performed using high-speed imaging and particle size counters
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2021.
- Individual participant dataSharing planned: Undecided. Anonymised data may be shared based upon consideration of reasonable requests from researchers with a stated objective.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy and Respiratory Tract Infections, run by Guy's and St Thomas' NHS Foundation Trust.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Characterisation of aerosolised respiratory droplets (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2021.