Smoke of Endoscopic Gastrointestinal Surgery

Endoscopic Surgery Clinical Trial

— SEGS  

Official title:

Composition, Hazard and Protection of Smoke From Endoscopic Gastrointestinal Surgery

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05367219
• Other study ID #: XJTU1AF2022LSK-204
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 5, 2022
• Est. completion date: November 30, 2022

Study information

• Verified date: March 2022
• Source: First Affiliated Hospital Xi'an Jiaotong University
• Contact: Yun Feng, M.D.
• Phone: +862985323920
• Email: amyyun[@]xjtu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 70
• Est. completion date: November 30, 2022
• Est. primary completion date: October 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Endoscopic Surgery
• Particulate Matter
• Smoke

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital Xi'an Jiaotong University

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Hazards of smoke to staff in the gastrointestinal endoscopy room	Proportion of the endoscopy staff with smoke related adverse reactions	During the surgery and 24 hours after the surgery.
Other	Viral quantitative of smoke from endoscopic gastrointestinal 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.	40 minutes after surgery.
Primary	PM2.5 in smoke from endoscopic gastrointestinal 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.	During the surgery.
Secondary	Some other harmful substances in smoke from endoscopic gastrointestinal 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.	During the surgery.