Smoke of Endoscopic Gastrointestinal Surgery

NCT05367219 | Unknown

• 1 other identifier: XJTU1AF2022LSK-204
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Smoke; Endoscopic Surgery; Particulate Matter

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Some other harmful substances in smoke from endoscopic gastrointestinal surgery.

  During the surgery.

Other Outcomes (2)

• Hazards of smoke to staff in the gastrointestinal endoscopy room

  During the surgery and 24 hours after the surgery.

• Viral quantitative of smoke from endoscopic gastrointestinal surgery

  40 minutes after surgery.

Study Arms (2)

Air sterilizer

EXPERIMENTAL

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

Control

NO INTERVENTION

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

Interventions

Air sterilizer DEVICE

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

Air sterilizer

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• First Affiliated Hospital Xi'an Jiaotong University: lead

Study Officials

• Shuixiang He

  First Affiliated Hospital of Xian Jiaotong University

  STUDY DIRECTOR

Central Study Contacts

Yun Feng, M.D.

CONTACT

+862985323920; amyyun@xjtu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2022
• First Posted: May 10, 2022
• Study Start: August 5, 2022
• Primary Completion: October 31, 2022
• Study Completion: November 30, 2022
• Last Updated: August 5, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share