The Evaluation of Pre-Post Smoke Evacuation Uses on Surgical Smoke and Bio-Aerosols in Operating Rooms
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|ClinicalTrials.gov Identifier: NCT02672969|
Recruitment Status : Unknown
Verified January 2016 by Usavadee Asdornwised, Mahidol University.
Recruitment status was: Recruiting
First Posted : February 3, 2016
Last Update Posted : February 3, 2016
|Condition or disease||Intervention/treatment||Phase|
|Smoke||Device: RapidVac Smoke Evacuator||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||128 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Evaluation of Pre-Post Smoke Evacuation Uses on Surgical Smoke and Bio-Aerosols in Operating Rooms at a University Hospital, Thailand|
|Study Start Date :||August 2015|
|Estimated Primary Completion Date :||February 2016|
|Estimated Study Completion Date :||March 2016|
Experimental: Smoke evacuation uses
Smoke evacuation uses means using RapidVac Smoke Evacuator with electrosurgical unit during coagulation and cutting surgery. (Experimental group)
Device: 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 Intervention: no smoke evacuation uses
No smoke evacuation uses means using only the regular electrosurgical unit during coagulation and cutting surgery. (Control group)
- 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 [ Time Frame: Operating time, about 1- 3 hours ]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
- 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 [ Time Frame: Surgical time 1-3 hours ]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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02672969
|Contact: Sunantha Thonklai, MSfirstname.lastname@example.org|
|Contact: Usavadee Asdornwised, PhDemail@example.com|
|Principal Investigator:||Usavadee Asdornwised, PhD||Faculty of Nursing, Mahidol University|