Exposure OccupationalSurgicalSmokNCT04880915
Effect of Fıve Different Methods On Smoke
A study testing surgical smoke affects in people with Exposure Occupational, run by Ege University at 1 site in Turkey (Türkiye).
Trial summary
Background: Electrosurgery is used in almost all surgeries. The entire surgical team working in these operating rooms is exposed to surgical smoke. In the literature, there is no study examining the direct effect of surgical smoke on operating room staff and involving the entire surgical team in sampling. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Exposure Occupational
- What is being tested?
- surgical smoke affects
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2018to 3 Sep 2019
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Working in the operating room and smoke exposure during total mastectomy surgery
- Agree to participate in the study,
Who cannot join
- Working in the other operations
- Not wanting to give blood or urine sample
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of The Effect Of Fıve Different Methods On Surgical Smoke Protection Experimental Research
Background: Electrosurgery is used in almost all surgeries. The entire surgical team working in these operating rooms is exposed to surgical smoke. In the literature, there is no study examining the direct effect of surgical smoke on operating room staff and involving the entire surgical team in sampling.
Materials and Methods: This experimental-type study was conducted in the operating room of the Department of General Surgery of a University Hospital. In the study, the surgeries were completed with standard practice and four different protective measures that could affect surgical smoke exposure. Blood and urine samples were collected from the surgical team before and after the surgery. Consequently, 70 blood and 70 urine samples were collected. The Wilcoxon signed-rank test was used to compare pre- and post-operative analyses.
Read the detailed description
- MATERIALS AND METHODS 2.1 Design of the Study This was an experimental study. 2.2 Population and Sample of the Study Pre- and post-operative blood and urine samples of the surgical team (surgeon, surgical resident, anaesthesiologist, scrub nurse, circulating nurse, support staff and researcher), who worked in the standard practice, and the use of four different preventive measures that may affect the surgical smoke exposure during total mastectomy surgery in the operating room of the General Surgery Department of a University Hospital between January 2019 and December 2019 created the sample of the study. During the study process, the surgeon, scrub nurse, circulating nurse and researcher were ensured to be the same people in each surgery. The surgical resident, anaesthesiologist, anaesthesia technician and support staff included in the study did not consist of the same people due to the change in the work schedules. Blood and urine samples were collected from a team of seven people before and after surgery [7 volunteers × 2 (blood and urine before and after surgery) = 14 (14 blood analysis + 14 urine analysis) 14 × 5 surgery = 70 (70 blood analysis + 70 urine analysis)].
2.3 Collection of Study Data 2.3.1 Data Collection Tools The Surgery Data Collection Form, which was created by the researchers in line with the relevant literature (Romano et al. 2016, 2017, Ragde et al. 2014; Tseng et al. 2014, Lin et al. 2010, Hollmann et al. 2004) to evaluate the information about the surgery, was used to collect the data. Other data collection tools were the N95 and safety equipment, the RapidVac™ Smoke Evacuator system for smoke evacuation, as well as the pencil type (smoke extractor) and smoke tubing evacuators.
2.3.2 Data Collection Method Blood and urine samples of the surgical team were collected before the total mastectomy in five different situations listed below that may affect surgical smoke exposure.
After the surgery is completed with routine applications (without taking any measures for smoke evacuation), After completing the surgery with the use of special safety equipment (N95 mask, safety glasses and without any measures for smoke evacuation), After the evacuation of the smoke caused by the surgery with a wall-mounted aspirator, After the evacuation of the smoke caused by the surgery with a smoke tubing and After the evacuation of the smoke caused by the surgery with a smoke evacuation pencil.
The blood samples were kept in a transport bag that maintained the temperature range between 2 and 4 °C until they reached the laboratory and kept at -20 °C for analysis. Blood samples were evaluated in the laboratory for benzene, toluene, xylene and styrene.
Similarly, the urine samples were kept in a transport bag that maintained the temperature range between 2 and 4 °C until they reached the laboratory and kept at -20 °C for analysis. The urine samples were evaluated in terms of urinary metabolites benzene-phenol-TT muconic acid, toluene-hippuric acid-O, cresol, xylene-hippuric acid and phenol-phenol in the laboratory.
Blood and urine analysis in the study was performed by the Central Research Test and Analysis Laboratory Application and Research Center of the university of this study.
2.3.3 Evaluation and Analysis of Data The study data was evaluated using the IBM SPSS Statistics 25.0 Statistics program. The Wilcoxon signed-rank test was used to compare pre- and post-operative analyses. Moreover, 0.05 was accepted as significant.
Gas chromatography/mass spectrometry was used for the analysis of blood and urine samples of the surgical team.
2.4 Ethical Aspect of Study Permission (11.01.2018-E.11195) was obtained from the Clinical Research Ethics Committee of the university of this study. Also, written permission (29.01.2018-E27595) from the institution where the research was conducted as well as informed written consent from the participants in the study were obtained.
- Conditions
- Exposure Occupational
- Being tested
- surgical smoke affects
- Keywords
- Surgical smoke, operating room, employee safety, nursing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surgical smoke affectsOther
Also called blood and urine samples
The study, experimental type, was conducted to investigate the effects of five different methods on surgical smoke protection.
| Study group | Role | What they receive |
|---|---|---|
| SMOKE PROTECTION | Experimental | Pre- and post-operative blood and urine samples of the surgical team (surgeon, surgical resident, anaesthesiologist, scrub nurse, circulating nurse, support staff and researcher), who worked in the standard practice, and the use of four different preventive measures that may affect the surgical smoke exposure during total mastectomy surgery in the operating room of the General Surgery Department of a University HospitaL. The surgical resident, anaesthesiologist, anaesthesia technician and support staff included in the study did not consist of the same people due to the change in the work schedules. Blood and urine samples were collected from a team of seven people before and after surgery [7 volunteers × 2 (blood and urine before and after surgery) = 14 (14 blood analysis + 14 urine analysis) 14 × 5 surgery = 70 (70 blood analysis + 70 urine analysis)]. Receives: Other: surgical smoke affects |
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigation of the preoperative and postoperative blood samples on Surgical Smoke Protection-Experimental Study
Electrosurgery is used in almost all surgeries. The entire surgical team working in these operating rooms is exposed to surgical smoke. In the literature, there is no study examining the direct effect of surgical smoke on operating room staff and involving the entire surgical team in sampling. Blood and urine samples were collected from surgical team before and after surgery. Blood samples were evaluated in the laboratory for volatile organic compound (benzene, toluene, xylene and styrene etc.)
Measured: "an average of 6 month"
Investigation of the preoperative and postoperative urine samples on Surgical Smoke Protection-Experimental Study
Electrosurgery is used in almost all surgeries. The entire surgical team working in these operating rooms is exposed to surgical smoke. In the literature, there is no study examining the direct effect of surgical smoke on operating room staff and involving the entire surgical team in sampling. Blood and urine samples were collected from surgical team before and after surgery. The urine samples were evaluated volatile organic compound (in terms of urinary metabolites benzene-phenol-TT muconic acid, toluene-hippuric acid-O, cresol, xylene-hippuric acid and phenol-phenol etc.) in the laboratory.
Measured: "an average of 6 month"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2021
- Study start1 Aug 2018
- Primary completion25 Feb 2019
- Study completion3 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Exposure OccupationalStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Burcak Sahin Koze, Ege University
- Investigators
- Burcak Sahin Koze, Mscn, Principal investigator, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04880915
- Sponsor's protocol ID
- Experimental
- Acronym
- SurgicalSmok
- Status last verified
- May 2021
- First submitted
- 24 Apr 2021
- Last updated
- 12 May 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of The Effect Of Fıve Different Methods On Surgical Smoke Protection Experimental Research
- ClinicalTrials.gov ID
- NCT04880915
- Acronym / sponsor ID
- SurgicalSmok / Experimental
- Conditions
- Exposure Occupational
- Keywords
- Surgical smoke, operating room, employee safety, nursing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 25 Feb 2019 (actual)
- Study completion
- 3 Sep 2019 (actual)
- First posted
- 11 May 2021 (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.
Background: Electrosurgery is used in almost all surgeries. The entire surgical team working in these operating rooms is exposed to surgical smoke. In the literature, there is no study examining the direct effect of surgical smoke on operating room staff and involving the entire surgical team in sampling.
Materials and Methods: This experimental-type study was conducted in the operating room of the Department of General Surgery of a University Hospital. In the study, the surgeries were completed with standard practice and four different protective measures that could affect surgical smoke exposure. Blood and urine samples were collected from the surgical team before and after the surgery. Consequently, 70 blood and 70 urine samples were collected. The Wilcoxon signed-rank test was used to compare pre- and post-operative analyses.
Detailed description
- MATERIALS AND METHODS 2.1 Design of the Study This was an experimental study. 2.2 Population and Sample of the Study Pre- and post-operative blood and urine samples of the surgical team (surgeon, surgical resident, anaesthesiologist, scrub nurse, circulating nurse, support staff and researcher), who worked in the standard practice, and the use of four different preventive measures that may affect the surgical smoke exposure during total mastectomy surgery in the operating room of the General Surgery Department of a University Hospital between January 2019 and December 2019 created the sample of the study. During the study process, the surgeon, scrub nurse, circulating nurse and researcher were ensured to be the same people in each surgery. The surgical resident, anaesthesiologist, anaesthesia technician and support staff included in the study did not consist of the same people due to the change in the work schedules. Blood and urine samples were collected from a team of seven people before and after surgery [7 volunteers × 2 (blood and urine before and after surgery) = 14 (14 blood analysis + 14 urine analysis) 14 × 5 surgery = 70 (70 blood analysis + 70 urine analysis)].
2.3 Collection of Study Data 2.3.1 Data Collection Tools The Surgery Data Collection Form, which was created by the researchers in line with the relevant literature (Romano et al. 2016, 2017, Ragde et al. 2014; Tseng et al. 2014, Lin et al. 2010, Hollmann et al. 2004) to evaluate the information about the surgery, was used to collect the data. Other data collection tools were the N95 and safety equipment, the RapidVac™ Smoke Evacuator system for smoke evacuation, as well as the pencil type (smoke extractor) and smoke tubing evacuators.
2.3.2 Data Collection Method Blood and urine samples of the surgical team were collected before the total mastectomy in five different situations listed below that may affect surgical smoke exposure.
After the surgery is completed with routine applications (without taking any measures for smoke evacuation), After completing the surgery with the use of special safety equipment (N95 mask, safety glasses and without any measures for smoke evacuation), After the evacuation of the smoke caused by the surgery with a wall-mounted aspirator, After the evacuation of the smoke caused by the surgery with a smoke tubing and After the evacuation of the smoke caused by the surgery with a smoke evacuation pencil.
The blood samples were kept in a transport bag that maintained the temperature range between 2 and 4 °C until they reached the laboratory and kept at -20 °C for analysis. Blood samples were evaluated in the laboratory for benzene, toluene, xylene and styrene.
Similarly, the urine samples were kept in a transport bag that maintained the temperature range between 2 and 4 °C until they reached the laboratory and kept at -20 °C for analysis. The urine samples were evaluated in terms of urinary metabolites benzene-phenol-TT muconic acid, toluene-hippuric acid-O, cresol, xylene-hippuric acid and phenol-phenol in the laboratory.
Blood and urine analysis in the study was performed by the Central Research Test and Analysis Laboratory Application and Research Center of the university of this study.
2.3.3 Evaluation and Analysis of Data The study data was evaluated using the IBM SPSS Statistics 25.0 Statistics program. The Wilcoxon signed-rank test was used to compare pre- and post-operative analyses. Moreover, 0.05 was accepted as significant.
Gas chromatography/mass spectrometry was used for the analysis of blood and urine samples of the surgical team.
2.4 Ethical Aspect of Study Permission (11.01.2018-E.11195) was obtained from the Clinical Research Ethics Committee of the university of this study. Also, written permission (29.01.2018-E27595) from the institution where the research was conducted as well as informed written consent from the participants in the study were obtained.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SMOKE PROTECTION | Experimental | Other: surgical smoke affectsPre- and post-operative blood and urine samples of the surgical team (surgeon, surgical resident, anaesthesiologist, scrub nurse, circulating nurse, support staff and researcher), who worked in the standard practice, and the use of four different preventive measures that may affect the surgical smoke exposure during total mastectomy surgery in the operating room of the General Surgery Department of a University HospitaL. The surgical resident, anaesthesiologist, anaesthesia technician and support staff included in the study did not consist of the same people due to the change in the work schedules. Blood and urine samples were collected from a team of seven people before and after surgery [7 volunteers × 2 (blood and urine before and after surgery) = 14 (14 blood analysis + 14 urine analysis) 14 × 5 surgery = 70 (70 blood analysis + 70 urine analysis)]. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Working in the operating room and smoke exposure during total mastectomy surgery
- Agree to participate in the study,
Key exclusion criteria (2 listed)
- Working in the other operations
- Not wanting to give blood or urine sample
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 |
|---|---|---|
| surgical smoke affectsAlso: blood and urine samplesThe study, experimental type, was conducted to investigate the effects of five different methods on surgical smoke protection. | Other | SMOKE PROTECTION |
Primary outcome
Investigation of the preoperative and postoperative blood samples on Surgical Smoke Protection-Experimental Study
Time frame: "an average of 6 month"
Electrosurgery is used in almost all surgeries. The entire surgical team working in these operating rooms is exposed to surgical smoke. In the literature, there is no study examining the direct effect of surgical smoke on operating room staff and involving the entire surgical team in sampling. Blood and urine samples were collected from surgical team before and after surgery. Blood samples were evaluated in the laboratory for volatile organic compound (benzene, toluene, xylene and styrene etc.)
Investigation of the preoperative and postoperative urine samples on Surgical Smoke Protection-Experimental Study
Time frame: "an average of 6 month"
Electrosurgery is used in almost all surgeries. The entire surgical team working in these operating rooms is exposed to surgical smoke. In the literature, there is no study examining the direct effect of surgical smoke on operating room staff and involving the entire surgical team in sampling. Blood and urine samples were collected from surgical team before and after surgery. The urine samples were evaluated volatile organic compound (in terms of urinary metabolites benzene-phenol-TT muconic acid, toluene-hippuric acid-O, cresol, xylene-hippuric acid and phenol-phenol etc.) in the laboratory.
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 12 May 2021.
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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.
Burcak Sahin Koze, Mscn principal investigator
Ege University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing surgical smoke affects in people with Exposure Occupational, run by Ege 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 2 inclusion and 2 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 12 May 2021. 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?
Investigation of the preoperative and postoperative blood samples on Surgical Smoke Protection-Experimental Study (time frame: "an average of 6 month"). 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 12 May 2021.