Surgical Procedure, UnspecifiedNCT06550492
Reducing the Negative Effects of Surgical Conditions Use of Double Layer Mask Against Electrocautery With Smoke Filter
A study testing smoke filtering electrocautery device and double mask in people with Surgical Procedure, Unspecified, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial 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 more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Surgical Procedure, Unspecified
- What is being tested?
- smoke filtering electrocautery device and double mask
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2023to 28 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Atatürk University Health Application and Research Centre
Erzurum, Yakutiye, 25200
About this study
Official title: In Reducing the Negative Effects of Surgical Conditions Comparison of Two Different Methods: Use of Double Layer Mask Against Smoke Filtering Electrocautery
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.
- Conditions
- Surgical Procedure, Unspecified
- Being tested
- smoke filtering electrocautery device, double mask
- Keywords
- surgical smoke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
smoke filtering electrocautery deviceDevice
A smoke-filtering electrocautery device was used during surgery.
double maskOther
A double-layer mask was used during the operation.
| Study group | Role | What they receive |
|---|---|---|
| experimental group using smoke filtering electrocautery device | Experimental | experimental group using smoke filtering electrocautery device Receives: Device: smoke filtering electrocautery device |
| experimental group using double mask | Experimental | experimental group using double mask Receives: Other: double mask |
| control group | No intervention | group using standard methods |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day
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
Measured: 1-2 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2024
- Study start1 Nov 2023
- Primary completion1 Nov 2023
- Study completion28 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical Procedure, UnspecifiedStudies of the same condition, open and under way.
- More trials run by Ataturk UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- experimental group using smoke filtering electrocautery device, experimental group using double mask and control group using single mask
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nurhan Bagacli, Ataturk University
- Investigators
- Zeynep Karaman Özlü, Professor, Study director, zkaraman@atauni.edu.tr
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06550492
- Sponsor's protocol ID
- AtaturkU25
- Status last verified
- Aug 2024
- First submitted
- 5 Aug 2024
- Last updated
- 13 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Reducing the Negative Effects of Surgical Conditions Comparison of Two Different Methods: Use of Double Layer Mask Against Smoke Filtering Electrocautery
- ClinicalTrials.gov ID
- NCT06550492
- Acronym / sponsor ID
- AtaturkU25
- Conditions
- Surgical Procedure, Unspecified
- Keywords
- surgical smoke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 1 Nov 2023 (actual)
- Study completion
- 28 Feb 2024 (actual)
- First posted
- 13 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 3
- Model description
- experimental group using smoke filtering electrocautery device, experimental group using double mask and control group using single mask
| Arm | Type | Receives |
|---|---|---|
| experimental group using smoke filtering electrocautery device | Experimental | Device: smoke filtering electrocautery deviceexperimental group using smoke filtering electrocautery device |
| experimental group using double mask | Experimental | Other: double maskexperimental group using double mask |
| control group | No intervention | –group using standard methods |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| smoke filtering electrocautery deviceA smoke-filtering electrocautery device was used during surgery. | Device | experimental group using smoke filtering electrocautery device |
| double maskA double-layer mask was used during the operation. | Other | experimental group using double mask |
Primary outcome
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.
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2024.
- Karaman Özlü Z., Uymaz Aras G., Bayrak A. (2022). Ameliyathanedeki Görünmez Tehlike: Cerrahi Duman. Arşiv Kaynak Tarama Dergisi, 31(1),10-14. doi:10.17827/aktd.969260Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zeynep Karaman Özlü, Professor study director
zkaraman@atauni.edu.tr
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing smoke filtering electrocautery device and double mask in people with Surgical Procedure, Unspecified, run by Ataturk University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Application Registration Form (time frame: 1 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2024.