Ignite Creation Date:
2025-12-24 @ 2:15 PM
Ignite Modification Date:
2026-01-01 @ 7:32 AM
Study NCT ID:
NCT04856995
Status:
COMPLETED
Last Update Posted:
2021-04-23
First Post:
2021-03-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Surgical Smoke on Air Quality
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2023-06-09', 'releaseDate': '2022-07-22'}], 'estimatedResultsFirstSubmitDate': '2022-07-22'}}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-06-29', 'size': 337835, 'label': 'Study Protocol, Statistical Analysis Plan, and Informed Consent Form', 'hasIcf': True, 'hasSap': True, 'filename': 'Prot_SAP_ICF_000.pdf', 'typeAbbrev': 'Prot_SAP_ICF', 'uploadDate': '2021-04-21T03:04', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 29}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-05-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2020-07-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-21', 'studyFirstSubmitDate': '2021-03-19', 'studyFirstSubmitQcDate': '2021-04-21', 'lastUpdatePostDateStruct': {'date': '2021-04-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AIR UALITY IN OPERATING ROOM', 'timeFrame': '29/06/2020- 20/07/2020', 'description': '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'}, {'measure': 'THE PHYSICAL SYMPTOMS', 'timeFrame': '29/06/2020- 20/07/2020', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Air Quality', 'Volatile Organic Compounds', 'Occupational Health']}, 'referencesModule': {'references': [{'pmid': '18461735', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '25421864', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '24570016', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '27007432', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '27345749', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': 'This study; It was planned to (1) determine the effect of surgical smoke on indoor air quality and (2) examine its effect on physical symptoms and throat culture results in operating room employees and compare it with those working in internal units.', 'detailedDescription': '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.\n\nMethod: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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Health workers in hospital', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Health workers in operating room\n\nExclusion Criteria:\n\n* those with chronic diseases such as Chronic Obstructive Pulmonary Disease, Asthma'}, 'identificationModule': {'nctId': 'NCT04856995', 'briefTitle': 'Effect of Surgical Smoke on Air Quality', 'organization': {'class': 'OTHER', 'fullName': 'Abant Izzet Baysal University'}, 'officialTitle': 'Comparison of The Effects of Surgical Smoke on The Air Quality And on The Physical Symptoms of Operating Room Staff', 'orgStudyIdInfo': {'id': 'AIBU-SBF-GES-02'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'working in the operating', 'description': 'operating room workers exposed to surgical smoke', 'interventionNames': ['Other: exposure to surgical smoke during surgery']}, {'label': 'working in internal units', 'description': 'Internal unit workers not exposed to surgical smoke'}], 'interventions': [{'name': 'exposure to surgical smoke during surgery', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['working in the operating']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14100', 'city': 'Bolu', 'country': 'Turkey (Türkiye)', 'facility': 'Bolu Abant İzzet Baysal Üniversitesi/Sağlık Bilimleri Fakültesi', 'geoPoint': {'lat': 40.73583, 'lon': 31.60611}}], 'overallOfficials': [{'name': 'GANİME E SOYSAL', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Abant Izzet Baysal University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'When article is published in the journal', 'ipdSharing': 'YES', 'description': 'STUDY PROTOCOL Data collection process\n\nDetermining the effect of surgical smoke on air quality Taking air samples in the general surgery operating room (n: 45)\n\n1. Example: 45 minutes before the start of the operation\n2. Example: 45 minutes from the beginning of the skin incision\n3. Example: 45 minutes after the operations are over\n\nDetermination of Physical Symptoms Caused by Surgical Smoke on Employees and Comparison\n\nPhysicians and nurses in internal units control group(n: 20)\n\nInformation Form Throat culture\n\nCase group (n: 19) Physicians and nurses exposed to surgical smoke in the general surgery operating room\n\n1. Before starting the operation Information form Throat culture\n2. After the surgery is over Information Form Throat culture', 'accessCriteria': 'Article is published in the journal'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abant Izzet Baysal University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2022-07-22', 'type': 'RELEASE'}, {'date': '2023-06-09', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Abant Izzet Baysal University'}}}}