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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
Sponsor:
Collaborator:
Medtronic - MITG
Information provided by (Responsible Party):
Usavadee Asdornwised, Mahidol University

Brief 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.

Condition or disease Intervention/treatment Phase
Smoke Device: RapidVac Smoke Evacuator Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 128 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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

Arm Intervention/treatment
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)



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Emergency cases

Information from the National Library of Medicine

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


Contacts
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Contact: Sunantha Thonklai, MS +66865274498 sue_thon@hotmail.com
Contact: Usavadee Asdornwised, PhD +66891285486 usavadee.asd@mahidol.ac.th

Locations
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Thailand
Mahidol University Recruiting
Bangkok, Thailand, 10700
Contact: Usavadee Asdornwised, Ph.D    +66891285486    usavadee.asd@mahidol.ac.th   
Contact: Sunantha Thonklai, MS    +66865274498    sue_thon@hotmail.com   
Principal Investigator: Usavadee Asdornwised, PhD         
Sponsors and Collaborators
Mahidol University
Medtronic - MITG
Investigators
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Principal Investigator: Usavadee Asdornwised, PhD Faculty of Nursing, Mahidol University
Publications of Results:
Other Publications:
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Responsible Party: Usavadee Asdornwised, Assoc.Prof.Dr., Mahidol University
ClinicalTrials.gov Identifier: NCT02672969    
Other Study ID Numbers: 248/2558 (EC1)
First Posted: February 3, 2016    Key Record Dates
Last Update Posted: February 3, 2016
Last Verified: January 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Usavadee Asdornwised, Mahidol University:
smoke evacuation system
surgical smoke