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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06550492
Enrollment
108
Registered
2024-08-13
Start date
2023-11-01
Completion date
2024-02-28
Last updated
2024-08-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Surgical Procedure, Unspecified

Keywords

surgical smoke

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.

Interventions

DEVICEsmoke filtering electrocautery device

A smoke-filtering electrocautery device was used during surgery.

OTHERdouble mask

A double-layer mask was used during the operation.

Sponsors

Ataturk University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Investigator)

Intervention model description

experimental group using smoke filtering electrocautery device, experimental group using double mask and control group using single mask

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Application Registration Form1 dayThis 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.
Questionnaire on Reported Health Problems1-2 dayThe 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

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026