Ignite Creation Date:
2025-12-24 @ 3:55 PM
Ignite Modification Date:
2025-12-26 @ 8:03 PM
Study NCT ID:
NCT06550492
Status:
COMPLETED
Last Update Posted:
2024-08-13
First Post:
2024-08-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Reducing the Negative Effects of Surgical Conditions Use of Double Layer Mask Against Electrocautery With Smoke Filter
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D004311', 'term': 'Double-Blind Method'}], 'ancestors': [{'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'experimental group using smoke filtering electrocautery device, experimental group using double mask and control group using single mask'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 108}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2024-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-09', 'studyFirstSubmitDate': '2024-08-05', 'studyFirstSubmitQcDate': '2024-08-09', 'lastUpdatePostDateStruct': {'date': '2024-08-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Application Registration Form', 'timeFrame': '1 day', 'description': 'This form includes laboratory findings such as COHb, MetHb, PaO2, PaCO2, pH, HCO3, SpO2, Hg that may be affected in the person exposed to surgical smoke. In the study, it was examined whether exposure to surgical smoke affected these values.'}, {'measure': 'Questionnaire on Reported Health Problems', 'timeFrame': '1-2 day', 'description': 'The questionnaire form, which was created by the researcher by reviewing the literature on the subject, includes 45 health problems that may occur in the short term as a result of exposure to surgical smoke and a scale related to the frequency of experiencing these problems. in the questionnaire, the every day option shows the maximum value, the never option shows the minimum value'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['surgical smoke'], 'conditions': ['Surgical Procedure, Unspecified']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://dergipark.org.tr/en/pub/aktd/article/969260', 'label': 'Karaman Özlü Z., Uymaz Aras G., Bayrak A. (2022). Ameliyathanedeki Görünmez Tehlike: Cerrahi Duman. Arşiv Kaynak Tarama Dergisi, 31(1),10-14. doi:10.17827/aktd.969260'}]}, 'descriptionModule': {'briefSummary': 'This study was conducted to determine and compare the effectiveness of the smoke filtering electrocautery device used to reduce the negative effects of surgical smoke and the use of a double layer mask.', 'detailedDescription': 'The research was conducted as a randomised controlled experimental study. The research was collected between November 2023 and February 2024 in Atatürk University Health Research and Application Centre Operating Theatre unit. Data were collected using the Personal Information Form, Specified Health Problems Questionnaire, and the Practice Record Form to record blood gas laboratory results. The study was conducted with 90 (30 control, 30 double mask, 30 device) operating theatre workers. The population of the study consisted of Atatürk University Health Practice and Research Hospital Operating Theatre unit employees between November 2023 and February 2024. In this study, a priori power analysis was performed to determine the sample size. In the power analysis, the sample of the study consisted of a total of 90 people, 30 people in the group using cautery device with smoke filtering system, 30 people in the group using double masks and 30 people in the control group, with an effect size of 0.5%, which is the medium effect size according to Cohen, an error margin level of 0.05% and a confidence interval of 0.95%, with a 95% population representativeness.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* people over the age of 18.\n* People who agreed to participate in the study,\n* who have been working in the operating theatre for at least one year.\n* people who do not have chronic diseases Voluntary personnel who volunteered to co-operate were included in the study.\n\nExclusion Criteria:\n\n* People who did not agree to participate in the study,\n* persons who have been working in the operating theatre for less than one year\n* people with chronic diseases,\n* people who withdrew from the study before all data were collected\n* Personnel whose laboratory results could not be analysed were excluded from the study.'}, 'identificationModule': {'nctId': 'NCT06550492', 'briefTitle': 'Reducing the Negative Effects of Surgical Conditions Use of Double Layer Mask Against Electrocautery With Smoke Filter', 'organization': {'class': 'OTHER', 'fullName': 'Ataturk University'}, 'officialTitle': 'In Reducing the Negative Effects of Surgical Conditions Comparison of Two Different Methods: Use of Double Layer Mask Against Smoke Filtering Electrocautery', 'orgStudyIdInfo': {'id': 'AtaturkU25'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'experimental group using smoke filtering electrocautery device', 'description': 'experimental group using smoke filtering electrocautery device', 'interventionNames': ['Device: smoke filtering electrocautery device']}, {'type': 'EXPERIMENTAL', 'label': 'experimental group using double mask', 'description': 'experimental group using double mask', 'interventionNames': ['Other: double mask']}, {'type': 'NO_INTERVENTION', 'label': 'control group', 'description': 'group using standard methods'}], 'interventions': [{'name': 'smoke filtering electrocautery device', 'type': 'DEVICE', 'description': 'A smoke-filtering electrocautery device was used during surgery.', 'armGroupLabels': ['experimental group using smoke filtering electrocautery device']}, {'name': 'double mask', 'type': 'OTHER', 'description': 'A double-layer mask was used during the operation.', 'armGroupLabels': ['experimental group using double mask']}]}, 'contactsLocationsModule': {'locations': [{'zip': '25200', 'city': 'Erzurum', 'state': 'Yakutiye', 'country': 'Turkey (Türkiye)', 'facility': 'Atatürk University Health Application and Research Centre', 'geoPoint': {'lat': 39.90861, 'lon': 41.27694}}], 'overallOfficials': [{'name': 'Zeynep Karaman Özlü, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'zkaraman@atauni.edu.tr'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ataturk University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief Researcher', 'investigatorFullName': 'Nurhan Bagacli', 'investigatorAffiliation': 'Ataturk University'}}}}