Smoke of Endoscopic Gastrointestinal Surgery

Study Overview
=================
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.

Official Title
-----------------
Composition, Hazard and Protection of Smoke From Endoscopic Gastrointestinal Surgery

Conditions
-----------------
Smoke, Endoscopic Surgery, Particulate Matter

Intervention / Treatment
-----------------
* Device: Air sterilizer


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Air sterilizer<br>The invesitigators will monitore smoke and try to remove the smoke with an air sterilizer during the endoscopic gastrointestinal surgery in the experimental group. | Device: Air sterilizer<br>* The invesitigators will try to remove the smoke with an air sterilizer during the endoscopic gastrointestinal surgery in the Air sterilizer group.<br>|
| No Intervention: Control<br>The control group was monitored for smoke during the endoscopic gastrointestinal surgery without any intervention. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |