NCT03724565

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,320

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 17, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 27, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 30, 2018

Completed
18 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 17, 2018

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 17, 2019

Completed
Last Updated

May 21, 2020

Status Verified

May 1, 2020

Enrollment Period

5 months

First QC Date

October 27, 2018

Last Update Submit

May 21, 2020

Conditions

Endoscopy, Gastrointestinal

Keywords

endoscopy, gastrointestinalair pollution, indoorRespiratory Protective Devices

Outcome Measures

Primary Outcomes (6)

  • atmospheric Carbon dioxide (CO2)

    CO2 ppb level in the area of endoscopic unit

    up to 1 week

  • atmospheric total volatile organic compound (TVOC)

    TVOC ppb level in the area of endoscopic unit

    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

    up to 1 week

  • atmospheric nitrogen dioxide (NO2)

    NO2 ppb level in the area of endoscopic unit

    up to 1 week

  • atmospheric carbon mono-oxide (CO)

    CO ppb level in the area of endoscopic unit

    up to 1 week

  • atmospheric ozone

    ozone ppb level in the area of endoscopic unit

    up to 1 week

Secondary Outcomes (3)

  • atmospheric temperature

    up to 1 week

  • atmospheric humidity

    up to 1 week

  • atmospheric pressure

    up to 1 week

Study Arms (3)

Endoscopic procedural area

air quality check of endoscopic procedural room

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

Interventions

Method of endoscopic procedurePROCEDURE

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)

Endoscopic procedural area

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • This study will check the only air quality in endoscopic unit of Hallym University Chuncheon Sacred Heart hospital of Korea, not a patients.

You may not qualify if:

  • This study will check the only air quality in endoscopic unit of Hallym University Chuncheon Sacred Heart hospital of Korea, not a patients.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chuncheon Sacred Heart hospital

Chuncheon, Gangwon-do, 24253, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 31583470DERIVED

Study Officials

  • Chang Seok Bang, MD, PhD

    Hallym University College of Medicine, Korea

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor of Hallym University College of Medicine

Study Record Dates

First Submitted

October 27, 2018

First Posted

October 30, 2018

Study Start

June 17, 2018

Primary Completion

November 17, 2018

Study Completion

July 17, 2019

Last Updated

May 21, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

There will be no patients-related data in this study (ecologic study)

Locations

KR(1)