Endoscopy, GastrointestinalNCT03724565
Air Quality Check in Gastrointestinal Endoscopy Unit
An observational study of Endoscopy, Gastrointestinal, run by Chuncheon Sacred Heart Hospital at 1 site in South Korea.
Trial summary
Air pollution sources in indoor area are one of the main factors for reducing indoor air quality of locations. A gastrointestinal endoscopy unit consists of the following area: procedural, recovery areas, and area for a disinfection and cleaning for equipment. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Endoscopy, Gastrointestinal
- What is being tested?
- Method of endoscopic procedure
- Type of treatment
- Surgery or procedure
- How many people
- 4,320 participants
- Where
- 1 siteSouth Korea
- Study dates
- 17 Jun 2018to 17 Jul 2019
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: This study will check the only air quality in endoscopic unit of Hallym University Chuncheon Sacred Heart hospital of Korea, not a patients.
Who may be able to join
- This study will check the only air quality in endoscopic unit of Hallym University Chuncheon Sacred Heart hospital of Korea, not a patients.
Who cannot join
- This study will check the only air quality in endoscopic unit of Hallym University Chuncheon Sacred Heart hospital of Korea, not a patients.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Chuncheon Sacred Heart hospital
Chuncheon, Gangwon-do, 24253
About this study
Official title: Air Quality Check in Gastrointestinal Endoscopy Unit Using Air Quality Monitoring Sensors
Air pollution sources in indoor area are one of the main factors for reducing indoor air quality of locations. A gastrointestinal endoscopy unit consists of the following area: procedural, recovery areas, and area for a disinfection and cleaning for equipment. This area is frequently exposed to the gastrointestinal gas expelled from patients and gas from electrocoagulated tissue through carbonation or electrocoagulation of neoplasms. This can be potential harmful component for respiratory health not only to medical practitioners but also to the patients who undergo endoscopic examinations. However, there has been scare data for the air quality check in the endoscopic unit.
Read the detailed description
Air pollution sources in indoor area are one of the main factors for reducing indoor air quality of locations. A gastrointestinal endoscopy unit consists of the following area: procedural, recovery areas, and area for a disinfection and cleaning for equipment. This area is frequently exposed to the gastrointestinal gas expelled from patients and gas from electrocoagulated tissue through carbonation or electrocoagulation of neoplasms (procedure of endoscopic submucosal dissection, endoscopic mucosal resection, etc). This can be potential harmful component for respiratory health not only to medical practitioners but also to the patients who undergo endoscopic examinations. However, there has been scare data for the air quality check in the endoscopic unit. The aim of this study is to check the air quality using conventional portable passive air quality monitoring sensors in gastrointestinal endoscopy unit.
- Conditions
- Endoscopy, Gastrointestinal
- Being tested
- Method of endoscopic procedure
- Keywords
- endoscopy, gastrointestinal, air pollution, indoor, Respiratory Protective Devices
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Method of endoscopic procedureProcedure or surgery
Air quality according to the method of endoscopic procedure will be checked (for example, upper diagnostic endoscopy, colonoscopy, endoscopic submucosal dissection, endoscopic mucosal resection, etc)
| Study group | Role | What they receive |
|---|---|---|
| Endoscopic procedural area | air quality check of endoscopic procedural room Receives: Procedure: Method of endoscopic procedure | |
| Recovery area for patients | air quality check of recovery area for patients in endoscopic unit | |
| Cleansing area for equipments | air quality check of cleansing area for equipments in endoscopic unit |
What is being measured
The primary outcome is the main question the study is designed to answer.
atmospheric Carbon dioxide (CO2)
CO2 ppb level in the area of endoscopic unit
Measured: up to 1 week
atmospheric total volatile organic compound (TVOC)
TVOC ppb level in the area of endoscopic unit
Measured: up to 1 week
atmospheric particulate matter that have a diameter of less than 2.5 micrometer (PM2.5)
PM2.5 ug/m3 level in the area of endoscopic unit
Measured: up to 1 week
atmospheric nitrogen dioxide (NO2)
NO2 ppb level in the area of endoscopic unit
Measured: up to 1 week
atmospheric carbon mono-oxide (CO)
CO ppb level in the area of endoscopic unit
Measured: up to 1 week
atmospheric ozone
ozone ppb level in the area of endoscopic unit
Measured: up to 1 week
Secondary outcomes (3)
atmospheric temperature
atmospheric temperature in the area of endoscopic unit
Measured: up to 1 week
atmospheric humidity
atmospheric humidity in the area of endoscopic unit
Measured: up to 1 week
atmospheric pressure
atmospheric pressure in the area of endoscopic unit
Measured: up to 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2018
- Study start17 Jun 2018
- Primary completion17 Nov 2018
- Study completion17 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Endoscopy, GastrointestinalStudies 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
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 4,320 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chuncheon Sacred Heart Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chang Seok Bang, Chuncheon Sacred Heart Hospital
- Investigators
- Chang Seok Bang, MD, PhD, Principal investigator, Hallym University College of Medicine, Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03724565
- Sponsor's protocol ID
- bangairquality
- Status last verified
- May 2020
- First submitted
- 27 Oct 2018
- Last updated
- 21 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There will be no patients-related data in this study (ecologic study)
Publications
Bang CS, Lee K, Yang YJ, Baik GH. Ambient air pollution in gastrointestinal endoscopy unit. Surg Endosc. 2020 Sep;34(9):3795-3804. doi: 10.1007/s00464-019-07144-8. Epub 2019 Oct 3.
PubMed 31583470
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Air Quality Check in Gastrointestinal Endoscopy Unit Using Air Quality Monitoring Sensors
- ClinicalTrials.gov ID
- NCT03724565
- Acronym / sponsor ID
- bangairquality
- Conditions
- Endoscopy, Gastrointestinal
- Keywords
- endoscopy, gastrointestinal, air pollution, indoor, Respiratory Protective Devices
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,320 participants (actual)
- Lead sponsor
- Chuncheon Sacred Heart HospitalUniversity, hospital or other
- Study start
- 17 Jun 2018 (actual)
- Primary completion
- 17 Nov 2018 (actual)
- Study completion
- 17 Jul 2019 (actual)
- First posted
- 30 Oct 2018 (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.
Air pollution sources in indoor area are one of the main factors for reducing indoor air quality of locations. A gastrointestinal endoscopy unit consists of the following area: procedural, recovery areas, and area for a disinfection and cleaning for equipment. This area is frequently exposed to the gastrointestinal gas expelled from patients and gas from electrocoagulated tissue through carbonation or electrocoagulation of neoplasms. This can be potential harmful component for respiratory health not only to medical practitioners but also to the patients who undergo endoscopic examinations. However, there has been scare data for the air quality check in the endoscopic unit.
Detailed description
Air pollution sources in indoor area are one of the main factors for reducing indoor air quality of locations. A gastrointestinal endoscopy unit consists of the following area: procedural, recovery areas, and area for a disinfection and cleaning for equipment. This area is frequently exposed to the gastrointestinal gas expelled from patients and gas from electrocoagulated tissue through carbonation or electrocoagulation of neoplasms (procedure of endoscopic submucosal dissection, endoscopic mucosal resection, etc). This can be potential harmful component for respiratory health not only to medical practitioners but also to the patients who undergo endoscopic examinations. However, there has been scare data for the air quality check in the endoscopic unit. The aim of this study is to check the air quality using conventional portable passive air quality monitoring sensors in gastrointestinal endoscopy unit.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Endoscopic procedural area | – | Procedure: Method of endoscopic procedureair quality check of endoscopic procedural room |
| Recovery area for patients | – | –air quality check of recovery area for patients in endoscopic unit |
| Cleansing area for equipments | – | –air quality check of cleansing area for equipments in endoscopic unit |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This study will check the only air quality in endoscopic unit of Hallym University Chuncheon Sacred Heart hospital of Korea, not a patients.
Key inclusion criteria (1 listed)
- This study will check the only air quality in endoscopic unit of Hallym University Chuncheon Sacred Heart hospital of Korea, not a patients.
Key exclusion criteria (1 listed)
- This study will check the only air quality in endoscopic unit of Hallym University Chuncheon Sacred Heart hospital of Korea, not a patients.
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 |
|---|---|---|
| Method of endoscopic procedureAir quality according to the method of endoscopic procedure will be checked (for example, upper diagnostic endoscopy, colonoscopy, endoscopic submucosal dissection, endoscopic mucosal resection, etc) | Procedure or surgery | Endoscopic procedural area |
Primary outcome
atmospheric Carbon dioxide (CO2)
Time frame: up to 1 week
CO2 ppb level in the area of endoscopic unit
atmospheric total volatile organic compound (TVOC)
Time frame: up to 1 week
TVOC ppb level in the area of endoscopic unit
atmospheric particulate matter that have a diameter of less than 2.5 micrometer (PM2.5)
Time frame: up to 1 week
PM2.5 ug/m3 level in the area of endoscopic unit
atmospheric nitrogen dioxide (NO2)
Time frame: up to 1 week
NO2 ppb level in the area of endoscopic unit
atmospheric carbon mono-oxide (CO)
Time frame: up to 1 week
CO ppb level in the area of endoscopic unit
atmospheric ozone
Time frame: up to 1 week
ozone ppb level in the area of endoscopic unit
3 secondary outcomes
atmospheric temperature
Time frame: up to 1 week
atmospheric humidity
Time frame: up to 1 week
atmospheric pressure
Time frame: up to 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2020.
- Derived from this study: PubMed 31583470Bang CS, Lee K, Yang YJ, Baik GH. Ambient air pollution in gastrointestinal endoscopy unit. Surg Endosc. 2020 Sep;34(9):3795-3804. doi: 10.1007/s00464-019-07144-8. Epub 2019 Oct 3.
- Individual participant dataSharing planned: No. There will be no patients-related data in this study (ecologic study)
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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.
Chang Seok Bang, MD, PhD principal investigator
Hallym University College of Medicine, Korea
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 Endoscopy, Gastrointestinal, run by Chuncheon Sacred Heart Hospital at 1 site in South Korea.
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: finished, as of the sponsor's last update on 21 May 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 South Korea. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
atmospheric Carbon dioxide (CO2) (time frame: up to 1 week). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03724565, which also lists 1 linked publication.
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 May 2020.