Smoke of Endoscopic Gastrointestinal Surgery (SEGS)

Xi'an Jiaotong University

Status: Unknown

Conditions: Particulate Matter; Smoke; Endoscopic Surgery

Treatments: Device: Air sterilizer

Study type: Interventional

Funder types: Other

Identifiers

NCT05367219

XJTU1AF2022LSK-204

Details and patient eligibility

About

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.

Full 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.

Enrollment: 70 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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70 participants in 2 patient groups

Air sterilizer

Experimental group

Description:

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

Treatment:

Device: Air sterilizer

Control

No Intervention group

Description:

The control group was monitored for smoke during the endoscopic gastrointestinal surgery without any intervention.