NCT02672969

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
128

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 21, 2016

Completed
11 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 3, 2016

Completed
27 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

February 3, 2016

Status Verified

January 1, 2016

Enrollment Period

6 months

First QC Date

January 21, 2016

Last Update Submit

January 30, 2016

Conditions

Smoke

Keywords

smoke evacuation systemsurgical smoke

Outcome Measures

Primary Outcomes (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

    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

Secondary Outcomes (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

    Surgical time 1-3 hours

Study Arms (2)

Smoke evacuation uses

EXPERIMENTAL

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

Device: RapidVac Smoke Evacuator

no smoke evacuation uses

NO INTERVENTION

No smoke evacuation uses means using only the regular electrosurgical unit during coagulation and cutting surgery. (Control group)

Interventions

RapidVac Smoke EvacuatorDEVICE

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).

Smoke evacuation uses

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Emergency cases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mahidol University

Bangkok, Bangkok, 10700, Thailand

RECRUITING

Related Publications (3)

  • 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. doi: 10.1007/s00464-002-8584-5. Epub 2003 Mar 19.

    PMID: 12640543BACKGROUND

  • Sanderson C. Surgical smoke. J Perioper Pract. 2012 Apr;22(4):122-8. doi: 10.1177/175045891202200405.

    PMID: 22567763RESULT

  • 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.

    PMID: 20678603RESULT

Study Officials

  • Usavadee Asdornwised, PhD

    Faculty of Nursing, Mahidol University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sunantha Thonklai, MS

CONTACT

+66865274498sue_thon@hotmail.com

Usavadee Asdornwised, PhD

CONTACT

+66891285486usavadee.asd@mahidol.ac.th

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc.Prof.Dr.

Study Record Dates

First Submitted

January 21, 2016

First Posted

February 3, 2016

Study Start

August 1, 2015

Primary Completion

February 1, 2016

Study Completion

March 1, 2016

Last Updated

February 3, 2016

Record last verified: 2016-01

Locations

TH(1)