跳至主要内容
临床试验/NCT05367219
NCT05367219Unknown不适用

Composition, Hazard and Protection of Smoke From Endoscopic Gastrointestinal Surgery

First Affiliated Hospital Xi'an Jiaotong University0 个研究点目标入组 70 人开始时间: 2022年8月5日最近更新:
适应症

试验速览

阶段
不适用
入组人数
70
主要终点
PM2.5 in smoke from endoscopic gastrointestinal surgery

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

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

结局指标

主要结局

PM2.5 in smoke from endoscopic gastrointestinal surgery

时间窗: During 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.

次要结局

  • Some other harmful substances in smoke from endoscopic gastrointestinal surgery.(During the surgery.)

研究者

申办方类型
Other
责任方
Sponsor

相似试验