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Smoke of Endoscopic Gastrointestinal Surgery

Composition, Hazard and Protection of Smoke From Endoscopic Gastrointestinal Surgery

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05367219
Acronym
SEGS
Enrollment
70
Registered
2022-05-10
Start date
2022-08-05
Completion date
2022-11-30
Last updated
2022-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endoscopic Surgery, Particulate Matter, Smoke

Brief summary

The purpose of this project is to study the composition, hazard, and protection of smoke from endoscopic gastrointestinal surgery. The study is a single-center, prospective, randomized, controlled, cohort study. The investigators plan to enroll 80 patients who undergo endoscopic gastrointestinal surgery and 10 medical staff participating in surgery in the gastrointestinal endoscopy room of the First Affiliated Hospital of Xi'an Jiao Tong University. The investigators will randomize the included study subjects. The investigators will monitore smoke and try to remove the smoke with an air sterilizer in the Air sterilizer group. The control group was monitored for smoke without any intervention. The primary endpoint is concentration of PM2.5 in smoke from endoscopic gastrointestinal surgery, the risk factors, and the effect of air sterilizer on its removal. The secondary endpoint is the concentration of PM1.0, PM10, formaldehyde, Total Volatile Organic Compounds, CO, and CO2 in smoke from endoscopic gastrointestinal surgery, the risk factors, and the effect of air sterilizer on its removal. Other exploratory objectives include the hazards of smoke to staff in the gastrointestinal endoscopy room, and the viral content of smoke.

Detailed description

The investigators will enroll 80 patients undergo endoscopic gastrointestinal surgery and 10 medical staff participate in surgery in the gastrointestinal endoscopy room. The patients will be randomized into the control group and the Air sterilizer group. The investigators will use air quality testing equipment to monitor the concentrations of the PM2.5, PM1.0, PM10, formaldehyde, Total Volatile Organic Compounds, CO, and CO2 of the smoke near the mouth and nose of the surgeon, cooperating nurse, and anesthesiologist, and try to remove the smoke with an air sterilizer in the Air sterilizer group. The control group was monitored for concentrations of the above ingredients in smoke without any intervention. The primary endpoint is concentration of PM2.5 in smoke during endoscopic gastrointestinal surgery, the risk factors related to surgery, and the effect of air sterilizer on its removal. The secondary endpoint is the concentration of PM1.0, PM10, formaldehyde, Total Volatile Organic Compounds, CO, and CO2 in smoke during endoscopic gastrointestinal surgery, the risk factors related to surgery, and the effect of air sterilizer on their removal. Other exploratory objectives include the hazards of smoke to staff in the gastrointestinal endoscopy room, and the viral quantitative of smoke.

Interventions

DEVICEAir sterilizer

The invesitigators will try to remove the smoke with an air sterilizer during the endoscopic gastrointestinal surgery in the Air sterilizer group.

Sponsors

First Affiliated Hospital Xi'an Jiaotong University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No

Inclusion criteria

* Patients who undergo endoscopic gastrointestinal surgery and medical staff who participate in the surgery in the gastrointestinal endoscopy operating room of the First Affiliated Hospital of Xi'an Jiao Tong University * Voluntary participation in this study

Exclusion criteria

* Severe liver disease * Severe Kidney disease * Severe cardiovascular disease * Severe cerebrovascular disease * Severe neuropsychiatric disease * Unable to cooperate with the research

Design outcomes

Primary

MeasureTime frameDescription
PM2.5 in smoke from endoscopic gastrointestinal surgeryDuring the surgery.Concentration of PM2.5 in smoke from endoscopic gastrointestinal surgery will be used by air quality testing equipment. The investigators will analyze the risk factors of PM2.5 related to surgery. The effect of air sterilizer on PM 2.5 removal will also be explored.

Secondary

MeasureTime frameDescription
Some other harmful substances in smoke from endoscopic gastrointestinal surgery.During the surgery.Concentration of some other harmful substances in smoke from endoscopic gastrointestinal surgery including PM1.0, PM10, formaldehyde, Total Volatile Organic Compounds, CO, and CO2 in smoke will be used by air quality testing equipment. The investigators will analyze the risk factors of PM1.0, PM10, formaldehyde, Total Volatile Organic Compounds, CO, and CO2 related to surgery. The effect of air sterilizer on PM1.0, PM10, formaldehyde, Total Volatile Organic Compounds, CO, and CO2 removal will also be explored.

Other

MeasureTime frameDescription
Hazards of smoke to staff in the gastrointestinal endoscopy roomDuring the surgery and 24 hours after the surgery.Proportion of the endoscopy staff with smoke related adverse reactions
Viral quantitative of smoke from endoscopic gastrointestinal surgery40 minutes after surgery.In the case of patients with HBV or HIV infection, the excised tissue will be electrocuted in vitro to measure the viral quantitative in the smoke.

Contacts

Primary ContactYun Feng, M.D.
amyyun@xjtu.edu.cn+862985323920

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026