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

A

Ataturk University

Status

Completed

Conditions

Surgical Procedure, Unspecified

Treatments

Device: smoke filtering electrocautery device
Other: double mask

Study type

Interventional

Funder types

Other

Identifiers

NCT06550492
AtaturkU25

Details and patient eligibility

About

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.

Full 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.

Enrollment

108 patients

Sex

All

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

108 participants in 3 patient groups

experimental group using smoke filtering electrocautery device
Experimental group
Description:
experimental group using smoke filtering electrocautery device
Treatment:
Device: smoke filtering electrocautery device
experimental group using double mask
Experimental group
Description:
experimental group using double mask
Treatment:
Other: double mask
control group
No Intervention group
Description:
group using standard methods

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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