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

Not Applicable

• Conditions: Smoke
• Interventions: Device: RapidVac Smoke Evacuator

• Registration Number: NCT02672969
• Lead Sponsor: 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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2015-08
• Status Verified: 2016-01
• Study First Submitted: 2016-01-21
• Study First Submitted QC: 2016-01-30
• Last Update Submitted: 2016-01-30
• Primary Completion: 2016-02
• Study First Posted: 2016-02-03
• Last Update Posted: 2016-02-03
• Study Completion: 2016-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 128

Inclusion Criteria

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

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Exclusion Criteria

• Emergency cases

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Smoke evacuation uses	RapidVac Smoke Evacuator	Smoke evacuation uses means using RapidVac Smoke Evacuator with electrosurgical unit during coagulation and cutting surgery. (Experimental group)

Primary Outcome Measures

Name	Time	Method
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	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

Name	Time	Method
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	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

Trial Locations

Locations (1)

Mahidol University; 🇹🇭 Bangkok, Thailand