- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret 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.
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
-
-
-
Bolu, Kalkun, 14100
- Bolu Abant İzzet Baysal Üniversitesi/Sağlık Bilimleri Fakültesi
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- Health workers in operating room
Exclusion Criteria:
- those with chronic diseases such as Chronic Obstructive Pulmonary Disease, Asthma
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
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
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
AIR UALITY IN OPERATING ROOM
Tidsramme: 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
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studieleder: GANİME E SOYSAL, Abant Izzet Baysal University
Publikationer og nyttige links
Generelle publikationer
- 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.
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- AIBU-SBF-GES-02
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (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
IPD-delingsadgangskriterier
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Arbejdsmiljø
-
Shanghai Mental Health CenterRekrutteringMental Health LiteracyKina
-
3-C Institute for Social DevelopmentUniversity of WashingtonAfsluttetMental Health ServicesForenede Stater
-
Colgate PalmoliveAfsluttetOral Health LiteracyIndien
-
European University CyprusAfsluttet
-
Universidad de ValparaisoRekrutteringMental Health LiteracyChile, Ecuador
-
Transcultural Psychosocial Organization NepalKing's College LondonRekrutteringMental Health WellnessNepal
-
Hospital Miguel ServetAktiv, ikke rekrutterendeMental Health WellnessSpanien
-
Wake Forest University Health SciencesAfsluttet
-
Fonterra Research CentreSun GenomicsAfsluttet
-
City University of Hong KongStanford University; Harvard UniversityAfsluttetMental Health WellnessColombia, Indonesien, Sydafrika, Ukraine