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Clinical Trials/NCT02672969
NCT02672969UnknownNot Applicable

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

Mahidol University2 sites in 1 country128 target enrollmentStarted: August 2015Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Enrollment
128
Locations
2
Primary Endpoint
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

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

  • Emergency cases

Outcomes

Primary Outcomes

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 Outcomes

  • 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)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Usavadee Asdornwised

Assoc.Prof.Dr.

Mahidol University

Study Sites (2)

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