Clinical trial NCT06550492: Reducing the Negative Effects of Surgical Conditions Use of Double Layer Mask Against Electrocautery With Smoke Filter
Official title: In Reducing the Negative Effects of Surgical Conditions Comparison of Two Different Methods: Use of Double Layer Mask Against Smoke Filtering Electrocautery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgical Procedure, Unspecified
Keywords: surgical smoke
Lead sponsor: Ataturk University
Sponsor class: OTHER
First posted: 2024-08-13
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: experimental group using smoke filtering electrocautery device, experimental group using double mask and control group using single mask
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* people over the age of 18.
* People who agreed to participate in the study,
* who have been working in the operating theatre for at least one year.
* people who do not have chronic diseases Voluntary personnel who volunteered to co-operate were included in the study.

Exclusion Criteria:

* People who did not agree to participate in the study,
* persons who have been working in the operating theatre for less than one year
* people with chronic diseases,
* people who withdrew from the study before all data were collected
* Personnel whose laboratory results could not be analysed were excluded from the study.

Primary outcomes:
measure: Application Registration Form
timeFrame: 1 day
measure: Questionnaire on Reported Health Problems
timeFrame: 1-2 day
Secondary outcomes:
Other outcomes:
Locations:
city: Erzurum
country: Turkey
facility: Atatürk University Health Application and Research Centre
state: Yakutiye
Study officials:
affiliation: zkaraman@atauni.edu.tr
name: Zeynep Karaman Özlü, Professor
role: STUDY_DIRECTOR
References: