The Evaluation of Pre-Post Smoke Evacuation Uses on Surgical Smoke and Bio-Aerosols in Operating Rooms

Smoke Clinical Trial

Official title:

The Evaluation of Pre-Post Smoke Evacuation Uses on Surgical Smoke and Bio-Aerosols in Operating Rooms at a University Hospital, Thailand

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02672969
• Other study ID #: 248/2558 (EC1)
• Status: Recruiting
• Phase: N/A
• First received: January 21, 2016
• Last updated: January 30, 2016
• Start date: August 2015
• Est. completion date: March 2016

Study information

• Verified date: January 2016
• Source: Mahidol University
• Contact: Sunantha Thonklai, MS
• Phone: +66865274498
• Email: sue_thon[@]hotmail.com
• Is FDA regulated: No
• Health authority: Thailand: Institutional Review BoardThailand: Food and Drug AdministrationUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 128
• Est. completion date: March 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Surgical patients who receive head-neck or breast surgery or surgical patients who receive abdominal laparoscopic surgery

Exclusion Criteria:

• Emergency cases

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Smoke

Intervention

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).

Locations

Country	Name	City	State
Thailand	Mahidol University	Bangkok

Sponsors (2)

Lead Sponsor	Collaborator
Mahidol University	Medtronic - MITG

Country where clinical trial is conducted

Thailand, 

References & Publications (3)

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. — View Citation

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. Epub 2003 Mar 19. Review. — View Citation

Sanderson C. Surgical smoke. J Perioper Pract. 2012 Apr;22(4):122-8. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Operating time, about 1- 3 hours	No
Secondary	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	Surgical time 1-3 hours	No