- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico 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
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Bolu, Pavo, 14100
- Bolu Abant İzzet Baysal Üniversitesi/Sağlık Bilimleri Fakültesi
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Health workers in operating room
Exclusion Criteria:
- those with chronic diseases such as Chronic Obstructive Pulmonary Disease, Asthma
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
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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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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AIR UALITY IN OPERATING ROOM
Periodo de tiempo: 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
Periodo de tiempo: 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
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: GANİME E SOYSAL, Abant Izzet Baysal University
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- AIBU-SBF-GES-02
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
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
Marco de tiempo para compartir IPD
Criterios de acceso compartido de IPD
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- CIF
- RSC
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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