An interventional study of RapidVac Smoke Evacuator in Smoke, sponsored by Mahidol University. Status unknown at 1 site in Thailand. Per ClinicalTrials.gov, last updated 2016-02-03.
Sponsored by Mahidol University · Not applicable, Interventional, and Prevention
This study aims to evaluate the pre-post smoke evacuation uses on surgical smoke and bio-aerosols particles in operating rooms at a university hospital, Thailand.
Purpose of Project
Smoke and bio-aerosols are routinely produced by surgical instruments; eg, lasers, electrosurgical units, radiofrequency devices, ultrasonic devices, power tools. Plume and bio-aerosols contain odor-causing and odorless toxic gases, vapors, dead and live cellular debris (including blood fragments), and viruses. These airborne contaminants can pose respiratory, ocular, dermatological and other health-related risks, including mutagenic and carcinogenic potential, to patients and operating room personnel. The National Institute of Occupational Safety and Health (NIOSH) and the Center for Disease Control (CDC) have also studied electrosurgical smoke at length. Therefore, the equipment of smoke evacuation in OR needs to be used. Therefore, this study aims to evaluate the pre-post smoke evacuation uses on surgical smoke and bio-aerosols particles in operating rooms at a university hospital, Thailand.
Methodology Association of periOperative Registered Nurses (AORN) guideline is used as the conceptual framework of this study including evidence based practice for smoke and bio-aerosols evacuation systems. The study design is a quasi-experimental study (manipulation and control only, without randomization) comparing the amount of surgical smoke and bio-aerosols particles pre- post smoke evacuation uses. The samples consist of 64 cases of surgical patients who receive head-neck or breast surgery and 64 cases of surgical patients who receive abdominal laparoscopic surgery. The amount of surgical smoke and bio-aerosols' particles in the surgical field and OR environment are measured by AeroTraxTM Handheld Airborne Particle Counter Model 9306.
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Exclusion Criteria:
Smoke evacuation uses means using RapidVac Smoke Evacuator with electrosurgical unit during coagulation and cutting surgery. (Experimental group)
Device: RapidVac Smoke Evacuator
No smoke evacuation uses means using only the regular electrosurgical unit during coagulation and cutting surgery. (Control group)
The intervention group, using the smoke evacuation (RapidVac Smoke Evacuator) in each OR, the data collection for the amount of surgical smoke and bio-aerosols' particles will be collected during pre-surgery and during surgery (every 30 mins). Before using the smoke evacuation, the amount of surgical smoke and bio-aerosols' particles in the surgical field and OR environment will be measured by AeroTraxTM Handheld Airborne Particle Counter. This record includes the amount and size of smoke and bio-aerosol particles in each area such as anesthetic area (anesthesiologist physicians and nurses area); instrument preparation area (circulating nurses area) and surgical area (surgeons and scrub nurses areas).
The amount of surgical smoke and bio-aerosols' particles in the Head, Neck & Breast/ Laparoscopic abdominal surgical field will be measured by AeroTraxTM Handheld Airborne Particle Counter Model 930
Measuring the smoke particles and using data record for the amount of particles (particles/ft3)(millions) in 3 areas; anesthetic area, instrument preparation area, and surgical area for the Head, Neck \& Breast surgery/Laparoscopic abdominal surgery
Time frame: Operating time, about 1- 3 hours
The size of surgical smoke and bio-aerosols' particles in the Head, Neck & Breast /Laparoscopic abdominal surgical field will be measured by AeroTraxTM Handheld Airborne Particle Counter Model 930
Measuring the particle size and using data record for size of particles (μm) (from 0.3 to 10 μm) in 3 areas; anesthetic area, instrument preparation area, and surgical area for the Head, Neck \& Breast surgery/Laparoscopic abdominal surgery
Time frame: Surgical time 1-3 hours
Plan to share: Undecided
This study is status unknown, as verified in Jan 2016. You cannot join it, but the record below documents what was studied.
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Mahidol University