- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
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Bolu, Tyrkia, 14100
- Bolu Abant İzzet Baysal Üniversitesi/Sağlık Bilimleri Fakültesi
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria:
- Health workers in operating room
Exclusion Criteria:
- those with chronic diseases such as Chronic Obstructive Pulmonary Disease, Asthma
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
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working in the operating
operating room workers exposed to surgical smoke
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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.
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working in internal units
Internal unit workers not exposed to surgical smoke
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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AIR UALITY IN OPERATING ROOM
Tidsramme: 29/06/2020- 20/07/2020
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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
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29/06/2020- 20/07/2020
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THE PHYSICAL SYMPTOMS
Tidsramme: 29/06/2020- 20/07/2020
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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.
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29/06/2020- 20/07/2020
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Studieleder: GANİME E SOYSAL, Abant Izzet Baysal University
Publikasjoner og nyttige lenker
Generelle publikasjoner
- 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.
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- AIBU-SBF-GES-02
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
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-delingstidsramme
Tilgangskriterier for IPD-deling
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
- SEVJE
- ICF
- CSR
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
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