The Evaluation of Pre-Post Smoke Evacuation Uses on Surgical Smoke and Bio-Aerosols in Operating Rooms
NCT ID: NCT02672969
Last Updated: 2016-02-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
128 participants
INTERVENTIONAL
2015-08-31
2016-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Smoke evacuation uses
Smoke evacuation uses means using RapidVac Smoke Evacuator with electrosurgical unit during coagulation and cutting surgery. (Experimental group)
RapidVac Smoke Evacuator
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).
no smoke evacuation uses
No smoke evacuation uses means using only the regular electrosurgical unit during coagulation and cutting surgery. (Control group)
No interventions assigned to this group
Interventions
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RapidVac Smoke Evacuator
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).
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
ALL
No
Sponsors
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Medtronic - MITG
INDUSTRY
Mahidol University
OTHER
Responsible Party
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Usavadee Asdornwised
Assoc.Prof.Dr.
Principal Investigators
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Usavadee Asdornwised, PhD
Role: PRINCIPAL_INVESTIGATOR
Faculty of Nursing, Mahidol University
Locations
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Mahidol University
Bangkok, Bangkok, Thailand
Countries
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Central Contacts
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Facility Contacts
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References
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Barrett WL, Garber SM. Surgical smoke: a review of the literature. Is this just a lot of hot air? Surg Endosc. 2003 Jun;17(6):979-87. doi: 10.1007/s00464-002-8584-5. Epub 2003 Mar 19.
Sanderson C. Surgical smoke. J Perioper Pract. 2012 Apr;22(4):122-8. doi: 10.1177/175045891202200405.
Ball K. Compliance with surgical smoke evacuation guidelines: implications for practice. AORN J. 2010 Aug;92(2):142-9. doi: 10.1016/j.aorn.2010.06.002.
Other Identifiers
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248/2558 (EC1)
Identifier Type: -
Identifier Source: org_study_id
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