Effect of Fıve Different Methods On Smoke

NCT ID: NCT04880915

Last Updated: 2021-05-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-01
• Study Completion Date: 2019-09-03

Brief 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.

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

2. 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

SMOKE PROTECTION

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 \[7 volunteers × 2 (blood and urine before and after surgery) = 14 (14 blood analysis + 14 urine analysis) 14 × 5 surgery = 70 (70 blood analysis + 70 urine analysis)\].

Group Type: EXPERIMENTAL

surgical smoke affects

Intervention Type: OTHER

The study, experimental type, was conducted to investigate the effects of five different methods on surgical smoke protection.

Interventions

surgical smoke affects

The study, experimental type, was conducted to investigate the effects of five different methods on surgical smoke protection.

Intervention Type: OTHER

Other Intervention Names

blood and urine samples

Eligibility Criteria

Inclusion Criteria

• Working in the operating room and smoke exposure during total mastectomy surgery
• Agree to participate in the study,

Exclusion Criteria

• Working in the other operations
• Not wanting to give blood or urine sample

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ege University

OTHER

Sponsor Role: lead

Responsible Party

Burcak Sahin Koze

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Burcak Sahin Koze, Mscn

Role: PRINCIPAL_INVESTIGATOR

Ege University

Locations

Ege University

Izmir, Bornova, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

Experimental

Identifier Type: -

Identifier Source: org_study_id