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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-01

Study Completion Date

2024-02-28

Brief Summary

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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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Detailed Description

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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.

Conditions

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Surgical Procedure, Unspecified

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Investigators

Study Groups

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experimental group using smoke filtering electrocautery device

Group Type EXPERIMENTAL

smoke filtering electrocautery device

Intervention Type DEVICE

A smoke-filtering electrocautery device was used during surgery.

experimental group using double mask

Group Type EXPERIMENTAL

double mask

Intervention Type OTHER

A double-layer mask was used during the operation.

control group

group using standard methods

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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smoke filtering electrocautery device

A smoke-filtering electrocautery device was used during surgery.

Intervention Type DEVICE

double mask

A double-layer mask was used during the operation.

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes