- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04856995
Effect of Surgical Smoke on Air Quality
Comparison of The Effects of Surgical Smoke on The Air Quality And on The Physical Symptoms of Operating Room Staff
Study Overview
Status
Intervention / Treatment
Detailed Description
Background:This study is a experimental study. The aim of this study is; to determine the effect of surgical smoke containing toxic chemicals on indoor air quality and to examine the physical symptoms of employees in the operating room.
Method:It was carried out in general surgery operating room between June 2020 and July 2020 In the study, 45 air samples were taken from the with active sampling method before, during and after surgery. Physical complaints of 19 people working in the operating room were asked and throat cultures were taken before and after surgery. These results were compared with those working in internal units. Data were analyzed using a statistics program.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Bolu, Turkey, 14100
- Bolu Abant İzzet Baysal Üniversitesi/Sağlık Bilimleri Fakültesi
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Health workers in operating room
Exclusion Criteria:
- those with chronic diseases such as Chronic Obstructive Pulmonary Disease, Asthma
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
working in the operating
operating room workers exposed to surgical smoke
|
No intervention was made.
During the surgery, complaints and throat cultures were taken before and after exposure to surgical smoke.
Simultaneously, 45 air samples are taken in the operating room before, during and after the operation.
|
|
working in internal units
Internal unit workers not exposed to surgical smoke
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
AIR UALITY IN OPERATING ROOM
Time Frame: 29/06/2020- 20/07/2020
|
Surgical smoke contains cellular materials including polycyclic aromatic hydrocarbons (PAH) and volatile organic compounds (VOC) from carcinogenic chemicals.In the study, 45 air samples were taken from the general surgery operating room with active sampling method before, during and after surgery
|
29/06/2020- 20/07/2020
|
|
THE PHYSICAL SYMPTOMS
Time Frame: 29/06/2020- 20/07/2020
|
Physical complaints of 19 people working in the general surgery operating room were asked and throat cultures were taken before and after surgery.
These results were compared with those working in internal units.
|
29/06/2020- 20/07/2020
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: GANİME E SOYSAL, Abant Izzet Baysal University
Publications and helpful links
General Publications
- Ulmer BC. The hazards of surgical smoke. AORN J. 2008 Apr;87(4):721-34; quiz 735-8. doi: 10.1016/j.aorn.2007.10.012.
- Okoshi K, Kobayashi K, Kinoshita K, Tomizawa Y, Hasegawa S, Sakai Y. Health risks associated with exposure to surgical smoke for surgeons and operation room personnel. Surg Today. 2015 Aug;45(8):957-65. doi: 10.1007/s00595-014-1085-z. Epub 2014 Nov 25.
- Choi SH, Kwon TG, Chung SK, Kim TH. Surgical smoke may be a biohazard to surgeons performing laparoscopic surgery. Surg Endosc. 2014 Aug;28(8):2374-80. doi: 10.1007/s00464-014-3472-3. Epub 2014 Feb 26.
- Tramontini CC, Galvao CM, Claudio CV, Ribeiro RP, Martins JT. [Composition of the electrocautery smoke: integrative literature review]. Rev Esc Enferm USP. 2016 Feb;50(1):148-57. doi: 10.1590/S0080-623420160000100019. Portuguese.
- Ilce A, Yuzden GE, Yavuz van Giersbergen M. The examination of problems experienced by nurses and doctors associated with exposure to surgical smoke and the necessary precautions. J Clin Nurs. 2017 Jun;26(11-12):1555-1561. doi: 10.1111/jocn.13455. Epub 2017 Mar 20.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- AIBU-SBF-GES-02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
STUDY PROTOCOL Data collection process
Determining the effect of surgical smoke on air quality Taking air samples in the general surgery operating room (n: 45)
- Example: 45 minutes before the start of the operation
- Example: 45 minutes from the beginning of the skin incision
- Example: 45 minutes after the operations are over
Determination of Physical Symptoms Caused by Surgical Smoke on Employees and Comparison
Physicians and nurses in internal units control group(n: 20)
Information Form Throat culture
Case group (n: 19) Physicians and nurses exposed to surgical smoke in the general surgery operating room
- Before starting the operation Information form Throat culture
- After the surgery is over Information Form Throat culture
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Occupational Health
-
Oregon Health and Science UniversityFederal Emergency Management Agency; National Fallen Firefighters FoundationCompletedHealth Behavior | Occupational Health | Total Worker HealthUnited States
-
Direction Centrale du Service de Santé des ArméesInstitut National de la Santé Et de la Recherche Médicale, FranceNot yet recruitingObservational Study | Occupational Health | Military Personnel | Exposure | Exposure Occupational | Firefighters | Health Adult Subjects | Health Behavior, Risky
-
Region ÖstergötlandLinkoeping UniversityCompletedOccupational HealthSweden
-
University of Texas at AustinNational Institute on Drug Abuse (NIDA)Completed
-
Linkoeping UniversityCompleted
-
BayerCompletedOccupational HealthBrazil
-
University of Texas at AustinNational Institute on Drug Abuse (NIDA)RecruitingOccupational HealthUnited States
-
National Taiwan University HospitalUnknown
-
Saglik Bilimleri UniversitesiCompletedLabor | Occupational Health | Work AccidentTurkey
-
VU University of AmsterdamUniversity of Copenhagen; University Hospital Heidelberg; World Health OrganizationRecruitingStress | Burnout | Occupational Health | Mental Health Conditions | Sickness AbsenceNetherlands
Clinical Trials on exposure to surgical smoke during surgery
-
Institut Català d'OncologiaFondazione IRCCS Istituto Nazionale dei Tumori, Milano; Mario Negri Institute... and other collaboratorsCompletedAsthma | COPD | Second Hand Tobacco Smoke
-
Maastricht UniversityMaastricht University Medical CenterCompletedDiabetes Mellitus, Type 2 | Prediabetic State | Glucose IntoleranceNetherlands
-
Xinhua Hospital, Shanghai Jiao Tong University...Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineCompletedSepsis | Postoperative Complications
-
Santiago R. Leal-NovalInstituto de Salud Carlos IIIUnknownGlioma | Surgery | Coagulopathy | Acquired Platelet Function Disorder | ThromboelastometrySpain
-
Technische Universität DresdenGerman Cancer Research CenterRecruiting
-
Virtual Incision CorporationEnrolling by invitation
-
Assistance Publique - Hôpitaux de ParisMinistry of Health, France; National Cancer Institute, FranceCompletedSmoking | Acute Coronary SyndromeFrance
-
Samsung Medical CenterCompletedThe Lamina Cribrosa and Optic Nerve Head Changes
-
Mansoura UniversityRecruiting
-
Hospital Sirio-LibanesRecruiting