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Completed

NCT Number: NCT06550492

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

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Atatürk University Health Application and Research Centre

Erzurum, Yakutiye, 25200, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

smoke filtering electrocautery device

Device

A smoke-filtering electrocautery device was used during surgery.

double mask

Other

A double-layer mask was used during the operation.

Primary outcomes

  1. Application Registration Form

    Time frame: 1 day

    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.

  2. Questionnaire on Reported Health Problems

    Time frame: 1-2 day

    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

Sponsors and collaborators

Lead sponsor

Ataturk University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Aug 13, 2024
Registry last updated
Aug 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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