To See if Colonoscopy is an Aerosol-generating Procedure and to Identify Ways to Minimise the Aerosol GeneratedNCT04479592
Colonoscopy is an Aerosol Generating Procedure
An observational study of To See if Colonoscopy is an Aerosol-generating Procedure and to Identify Ways to Minimise the Aerosol Generated, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
With a commercially available particle counter, we can differentiate the particle counts of different sizes in different areas of the endoscopy room. An increase from baseline particles of < 5um during or after the procedure would suggest that the procedure is an AGP. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- To See if Colonoscopy is an Aerosol-generating Procedure and to Identify Ways to Minimise the Aerosol Generated
- What is being tested?
- Particle counter
- How many people
- 120 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Jun 2020to 31 Jan 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients who are planned for colonoscopy in the Prince of Wales Hospital, Hong kong.
Who may be able to join
- All patients who are planned for colonoscopy in the Prince of Wales Hospital, Hong kong
Who cannot join
- Patients where a flexible sigmoidoscopy was plannned Patients where the procedure was done in a negative pressure room Patients where the procedure was done in an endoscopy room other than the designated rooms Patients where the procedure was done under general anaesthesia
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
Prince of Wales Hospital
Hong Kong, 00000
Shannon M Chan, FRCS, 852-35052627, shannonchan@surgery.cuhk.edu.hk
About this study
Official title: Colonoscopy is an Aerosol-generating Procedure and Water-immersion Technique May Decrease the Amount of Aerosol Generated
With a commercially available particle counter, we can differentiate the particle counts of different sizes in different areas of the endoscopy room. An increase from baseline particles of < 5um during or after the procedure would suggest that the procedure is an AGP.
In this study, the particle counter from Met One Instruments model GT-526S will be used. A particle sizer is placed within 10cm of the anus, at the level of the endoscopists' face and at the level of the endoscopy nurse assistant's face The change in the particles of different sizes would be simultaneously recorded. The results of these three locations are compared to baseline and compared with each other
Read the detailed description
Currently, the term droplet is often taken to refer to droplets >5 microns (μm) in diameter that fall rapidly to the ground under gravity, and therefore are transmitted only over a limited distance (e.g. ≤1 m). In contrast, the term droplet nuclei refers to droplets ≤5 μm in diameter that can remain suspended in air for significant periods of time, allowing them to be transmitted over distances >1 metre. With a commercially available particle counter, we can differentiate the particle counts of different sizes in different areas of the endoscopy room. An increase from baseline particles of < 5um during or after the procedure would suggest that the procedure is an AGP.
In this study, the particle counter from Met One Instruments model GT-526S will be used. The study will be conducted in the Prince of Wales Hospital endoscopy centre. A particle sizer is placed within 10cm of the anus, at the level of the endoscopists' face and at the level of the endoscopy nurse assistant's face The change in the particles of different sizes would be simultaneously recorded. The results of these three locations are compared to baseline and compared with each other.
- Being tested
- Particle counter
- Keywords
- Colonoscopy, Aerosol-generating procedure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Particle counterOther
Particle counter to measure the aerosol generated
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of aerosol generated during the procedure
Concentration of aerosol generated during the procedure
Measured: During the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2020
- Study start1 Jun 2020
- Primary completion30 Dec 2020 (estimated)
- Study completion31 Jan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for To See if Colonoscopy is an Aerosol-generating Procedure and to Identify Ways to Minimise the Aerosol GeneratedStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- 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
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, CHAN SHANNON MELISSA, Chinese University of Hong Kong
- Investigators
- Shannon M Chan, FRCSEd, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04479592
- Sponsor's protocol ID
- 2020.200.2
- Status last verified
- Jul 2020
- First submitted
- 17 Jul 2020
- Last updated
- 21 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Colonoscopy is an Aerosol-generating Procedure and Water-immersion Technique May Decrease the Amount of Aerosol Generated
- ClinicalTrials.gov ID
- NCT04479592
- Acronym / sponsor ID
- 2020.200.2
- Keywords
- Colonoscopy, Aerosol-generating procedure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 30 Dec 2020 (estimated)
- Study completion
- 31 Jan 2021 (estimated)
- First posted
- 21 Jul 2020 (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.
With a commercially available particle counter, we can differentiate the particle counts of different sizes in different areas of the endoscopy room. An increase from baseline particles of < 5um during or after the procedure would suggest that the procedure is an AGP.
In this study, the particle counter from Met One Instruments model GT-526S will be used. A particle sizer is placed within 10cm of the anus, at the level of the endoscopists' face and at the level of the endoscopy nurse assistant's face The change in the particles of different sizes would be simultaneously recorded. The results of these three locations are compared to baseline and compared with each other
Detailed description
Currently, the term droplet is often taken to refer to droplets >5 microns (μm) in diameter that fall rapidly to the ground under gravity, and therefore are transmitted only over a limited distance (e.g. ≤1 m). In contrast, the term droplet nuclei refers to droplets ≤5 μm in diameter that can remain suspended in air for significant periods of time, allowing them to be transmitted over distances >1 metre. With a commercially available particle counter, we can differentiate the particle counts of different sizes in different areas of the endoscopy room. An increase from baseline particles of < 5um during or after the procedure would suggest that the procedure is an AGP.
In this study, the particle counter from Met One Instruments model GT-526S will be used. The study will be conducted in the Prince of Wales Hospital endoscopy centre. A particle sizer is placed within 10cm of the anus, at the level of the endoscopists' face and at the level of the endoscopy nurse assistant's face The change in the particles of different sizes would be simultaneously recorded. The results of these three locations are compared to baseline and compared with each other.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients who are planned for colonoscopy in the Prince of Wales Hospital, Hong kong.
Key inclusion criteria (1 listed)
- All patients who are planned for colonoscopy in the Prince of Wales Hospital, Hong kong
Key exclusion criteria (1 listed)
- Patients where a flexible sigmoidoscopy was plannned Patients where the procedure was done in a negative pressure room Patients where the procedure was done in an endoscopy room other than the designated rooms Patients where the procedure was done under general anaesthesia
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 |
|---|---|---|
| Particle counterParticle counter to measure the aerosol generated | Other | – |
Primary outcome
Concentration of aerosol generated during the procedure
Time frame: During the procedure
Concentration of aerosol generated during the procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2020.
- Individual participant dataSharing planned: No
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.
Shannon M Chan, FRCSEd principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of To See if Colonoscopy is an Aerosol-generating Procedure and to Identify Ways to Minimise the Aerosol Generated, run by Chinese University of Hong Kong at 1 site in Hong Kong.
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 1 inclusion and 1 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 21 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Contact Shannon M Chan, FRCSEd (35052627, shannonchan@surgery.cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concentration of aerosol generated during the procedure (time frame: During the procedure). 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 21 Jul 2020.