Reducing the Negative Effects of Surgical Conditions Use of Double Layer Mask Against Electrocautery With Smoke Filter

In Reducing the Negative Effects of Surgical Conditions Comparison of Two Different Methods: Use of Double Layer Mask Against Smoke Filtering Electrocautery

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.

Study Overview

• Status: Completed
• Conditions: Surgical Procedure, Unspecified
• Intervention / Treatment: Device: smoke filtering electrocautery device; Other: double 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.

• Study Type: Interventional
• Enrollment (Actual): 108
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Yakutiye
    • Erzurum, Yakutiye, Turkey, 25200
      • Atatürk University Health Application and Research Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: experimental group using smoke filtering electrocautery device	Device: smoke filtering electrocautery device; A smoke-filtering electrocautery device was used during surgery.
Experimental: experimental group using double mask	Other: double mask; A double-layer mask was used during the operation.
No Intervention: control group; group using standard methods

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Application Registration Form	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.	1 day
Questionnaire on Reported Health Problems	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	1-2 day

Collaborators and Investigators

• Sponsor: Ataturk University
• Investigators: Study Director: Zeynep Karaman Özlü, Professor, zkaraman@atauni.edu.tr

Publications and helpful links

Helpful Links

• 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

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2023
• Primary Completion (Actual): November 1, 2023
• Study Completion (Actual): February 28, 2024

Study Registration Dates

• First Submitted: August 5, 2024
• First Submitted That Met QC Criteria: August 9, 2024
• First Posted (Actual): August 13, 2024

Study Record Updates

• Last Update Posted (Actual): August 13, 2024
• Last Update Submitted That Met QC Criteria: August 9, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: surgical smoke
• Other Study ID Numbers: AtaturkU25

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No