CClinicalTrials.gg
CompletedNCT06550492Updated Aug 13, 2024

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

An interventional study of smoke filtering electrocautery device and double mask in Surgical Procedure, Unspecified, sponsored by Ataturk University. Completed at 1 site in Turkey. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-13.

Sponsored by Ataturk University · Not applicable, Interventional, and Health services research

From the registry’s dates

  • Registered 9 months after the study started (first participant enrolled Nov 2023, registered Aug 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
108
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Surgical Procedure, Unspecified

Keywords

  • surgical smoke
03

In context

Lead sponsor

Ataturk University is the lead sponsor of 442 studies on the registry; 121 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts 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

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.
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Investigator)
Enrollment
108 participants (actual)

Study arms

  • Experimental
    experimental group using smoke filtering electrocautery device

    experimental group using smoke filtering electrocautery device

    Device: smoke filtering electrocautery device

  • Experimental
    experimental group using double mask

    experimental group using double mask

    Other: double mask

  • No intervention
    control group

    group using standard methods

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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 1 day

  2. 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

    Time frame: 1-2 day

07

Study locations

1 site
  • Atatürk University Health Application and Research Centre
    Erzurum, Yakutiye 25200, Turkey
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 13, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06550492
Lead sponsor
Ataturk University
Responsible party
Nurhan Bagacli (Chief Researcher, Ataturk University) — Principal investigator
First posted
Aug 13, 2024
Start date
Nov 1, 2023
Primary completion
Nov 1, 2023
Completion
Feb 28, 2024
Last update
Aug 13, 2024

Study contacts

Zeynep Karaman Özlü, Professor
study director · zkaraman@atauni.edu.tr

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion