Air QualityNCT04856995
Effect of Surgical Smoke on Air Quality
An observational study of Air Quality and Volatile Organic Compounds, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
Trial summary
This study; It was planned to (1) determine the effect of surgical smoke on indoor air quality and (2) examine its effect on physical symptoms and throat culture results in operating room employees and compare it with those working in internal units. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Air Quality, Volatile Organic Compounds, Occupational Health
- What is being tested?
- exposure to surgical smoke during surgery
- How many people
- 29 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 May 2020to 20 Jul 2020
- Phase
- Observational
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Health workers in hospital
Who may be able to join
- Health workers in operating room
Who cannot join
- those with chronic diseases such as Chronic Obstructive Pulmonary Disease, Asthma
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bolu Abant İzzet Baysal Üniversitesi/Sağlık Bilimleri Fakültesi
Bolu, 14100
About this study
Official title: Comparison of The Effects of Surgical Smoke on The Air Quality And on The Physical Symptoms of Operating Room Staff
This study; It was planned to (1) determine the effect of surgical smoke on indoor air quality and (2) examine its effect on physical symptoms and throat culture results in operating room employees and compare it with those working in internal units.
Read the detailed description
Background:This study is a experimental study. The aim of this study is; to determine the effect of surgical smoke containing toxic chemicals on indoor air quality and to examine the physical symptoms of employees in the operating room.
Method:It was carried out in general surgery operating room between June 2020 and July 2020 In the study, 45 air samples were taken from the with active sampling method before, during and after surgery. Physical complaints of 19 people working in the operating room were asked and throat cultures were taken before and after surgery. These results were compared with those working in internal units. Data were analyzed using a statistics program.
- Conditions
- Air Quality, Volatile Organic Compounds, Occupational Health
- Being tested
- exposure to surgical smoke during surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exposure to surgical smoke during surgeryOther
No intervention was made. During the surgery, complaints and throat cultures were taken before and after exposure to surgical smoke. Simultaneously, 45 air samples are taken in the operating room before, during and after the operation.
| Study group | Role | What they receive |
|---|---|---|
| working in the operating | operating room workers exposed to surgical smoke Receives: Other: exposure to surgical smoke during surgery | |
| working in internal units | Internal unit workers not exposed to surgical smoke |
What is being measured
The primary outcome is the main question the study is designed to answer.
AIR UALITY IN OPERATING ROOM
Surgical smoke contains cellular materials including polycyclic aromatic hydrocarbons (PAH) and volatile organic compounds (VOC) from carcinogenic chemicals.In the study, 45 air samples were taken from the general surgery operating room with active sampling method before, during and after surgery
Measured: 29/06/2020- 20/07/2020
THE PHYSICAL SYMPTOMS
Physical complaints of 19 people working in the general surgery operating room were asked and throat cultures were taken before and after surgery. These results were compared with those working in internal units.
Measured: 29/06/2020- 20/07/2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2021
- Study start12 May 2020
- Primary completion20 Jul 2020
- Study completion20 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Air QualityStudies of the same condition, open and under way.
- More trials run by Abant Izzet Baysal 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abant Izzet Baysal University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- GANİME E SOYSAL, Study director, Abant Izzet Baysal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04856995
- Sponsor's protocol ID
- AIBU-SBF-GES-02
- Status last verified
- Apr 2021
- First submitted
- 19 Mar 2021
- Last updated
- 23 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: STUDY PROTOCOL Data collection process Determining the effect of surgical smoke on air quality Taking air samples in the general surgery operating room (n: 45) 1. Example: 45 minutes before the start of the operation 2. Example: 45 minutes from the beginning of the skin incision 3. Example: 45 minutes after the operations are over Determination of Physical Symptoms Caused by Surgical Smoke on Employees and Comparison Physicians and nurses in internal units control group(n: 20) Information Form Throat culture Case group (n: 19) Physicians and nurses exposed to surgical smoke in the general surgery operating room 1. Before starting the operation Information form Throat culture 2. After the surgery is over Information Form Throat culture
Publications
Ulmer BC. The hazards of surgical smoke. AORN J. 2008 Apr;87(4):721-34; quiz 735-8. doi: 10.1016/j.aorn.2007.10.012.
PubMed 18461735Okoshi K, Kobayashi K, Kinoshita K, Tomizawa Y, Hasegawa S, Sakai Y. Health risks associated with exposure to surgical smoke for surgeons and operation room personnel. Surg Today. 2015 Aug;45(8):957-65. doi: 10.1007/s00595-014-1085-z. Epub 2014 Nov 25.
PubMed 25421864Choi SH, Kwon TG, Chung SK, Kim TH. Surgical smoke may be a biohazard to surgeons performing laparoscopic surgery. Surg Endosc. 2014 Aug;28(8):2374-80. doi: 10.1007/s00464-014-3472-3. Epub 2014 Feb 26.
PubMed 24570016Tramontini CC, Galvao CM, Claudio CV, Ribeiro RP, Martins JT. [Composition of the electrocautery smoke: integrative literature review]. Rev Esc Enferm USP. 2016 Feb;50(1):148-57. doi: 10.1590/S0080-623420160000100019. Portuguese.
PubMed 27007432Ilce A, Yuzden GE, Yavuz van Giersbergen M. The examination of problems experienced by nurses and doctors associated with exposure to surgical smoke and the necessary precautions. J Clin Nurs. 2017 Jun;26(11-12):1555-1561. doi: 10.1111/jocn.13455. Epub 2017 Mar 20.
PubMed 27345749
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of The Effects of Surgical Smoke on The Air Quality And on The Physical Symptoms of Operating Room Staff
- ClinicalTrials.gov ID
- NCT04856995
- Acronym / sponsor ID
- AIBU-SBF-GES-02
- Conditions
- Air Quality, Volatile Organic Compounds, Occupational Health
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Abant Izzet Baysal UniversityUniversity, hospital or other
- Study start
- 12 May 2020 (actual)
- Primary completion
- 20 Jul 2020 (actual)
- Study completion
- 20 Jul 2020 (actual)
- First posted
- 23 Apr 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.
This study; It was planned to (1) determine the effect of surgical smoke on indoor air quality and (2) examine its effect on physical symptoms and throat culture results in operating room employees and compare it with those working in internal units.
Detailed description
Background:This study is a experimental study. The aim of this study is; to determine the effect of surgical smoke containing toxic chemicals on indoor air quality and to examine the physical symptoms of employees in the operating room.
Method:It was carried out in general surgery operating room between June 2020 and July 2020 In the study, 45 air samples were taken from the with active sampling method before, during and after surgery. Physical complaints of 19 people working in the operating room were asked and throat cultures were taken before and after surgery. These results were compared with those working in internal units. Data were analyzed using a statistics program.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| working in the operating | – | Other: exposure to surgical smoke during surgeryoperating room workers exposed to surgical smoke |
| working in internal units | – | –Internal unit workers not exposed to surgical smoke |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Health workers in hospital
Key inclusion criteria (1 listed)
- Health workers in operating room
Key exclusion criteria (1 listed)
- those with chronic diseases such as Chronic Obstructive Pulmonary Disease, Asthma
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 |
|---|---|---|
| exposure to surgical smoke during surgeryNo intervention was made. During the surgery, complaints and throat cultures were taken before and after exposure to surgical smoke. Simultaneously, 45 air samples are taken in the operating room before, during and after the operation. | Other | working in the operating |
Primary outcome
AIR UALITY IN OPERATING ROOM
Time frame: 29/06/2020- 20/07/2020
Surgical smoke contains cellular materials including polycyclic aromatic hydrocarbons (PAH) and volatile organic compounds (VOC) from carcinogenic chemicals.In the study, 45 air samples were taken from the general surgery operating room with active sampling method before, during and after surgery
THE PHYSICAL SYMPTOMS
Time frame: 29/06/2020- 20/07/2020
Physical complaints of 19 people working in the general surgery operating room were asked and throat cultures were taken before and after surgery. These results were compared with those working in internal units.
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 23 Apr 2021.
- Background: PubMed 18461735Ulmer BC. The hazards of surgical smoke. AORN J. 2008 Apr;87(4):721-34; quiz 735-8. doi: 10.1016/j.aorn.2007.10.012.
- Background: PubMed 25421864Okoshi K, Kobayashi K, Kinoshita K, Tomizawa Y, Hasegawa S, Sakai Y. Health risks associated with exposure to surgical smoke for surgeons and operation room personnel. Surg Today. 2015 Aug;45(8):957-65. doi: 10.1007/s00595-014-1085-z. Epub 2014 Nov 25.
- Background: PubMed 24570016Choi SH, Kwon TG, Chung SK, Kim TH. Surgical smoke may be a biohazard to surgeons performing laparoscopic surgery. Surg Endosc. 2014 Aug;28(8):2374-80. doi: 10.1007/s00464-014-3472-3. Epub 2014 Feb 26.
- Background: PubMed 27007432Tramontini CC, Galvao CM, Claudio CV, Ribeiro RP, Martins JT. [Composition of the electrocautery smoke: integrative literature review]. Rev Esc Enferm USP. 2016 Feb;50(1):148-57. doi: 10.1590/S0080-623420160000100019. Portuguese.
- Background: PubMed 27345749Ilce A, Yuzden GE, Yavuz van Giersbergen M. The examination of problems experienced by nurses and doctors associated with exposure to surgical smoke and the necessary precautions. J Clin Nurs. 2017 Jun;26(11-12):1555-1561. doi: 10.1111/jocn.13455. Epub 2017 Mar 20.
- Individual participant dataSharing planned: Yes. STUDY PROTOCOL Data collection process Determining the effect of surgical smoke on air quality Taking air samples in the general surgery operating room (n: 45) 1. Example: 45 minutes before the start of the operation 2. Example: 45 minutes from the beginning of the skin incision 3. Example: 45 minutes after the operations are over Determination of Physical Symptoms Caused by Surgical Smoke on Employees and Comparison Physicians and nurses in internal units control group(n: 20) Information Form Throat culture Case group (n: 19) Physicians and nurses exposed to surgical smoke in the general surgery operating room 1. Before starting the operation Information form Throat culture 2. After the surgery is over Information Form Throat culture
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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.
GANİME E SOYSAL study director
Abant Izzet Baysal University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Air Quality and Volatile Organic Compounds, run by Abant Izzet Baysal 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 1 inclusion and 1 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 23 Apr 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?
AIR UALITY IN OPERATING ROOM (time frame: 29/06/2020- 20/07/2020). 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?
On the ClinicalTrials.gov record for NCT04856995, which also lists 5 linked publications.
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 23 Apr 2021.