Lung CancerNCT03924206
Hazardous Surgical Smoke: Risk Assessment and Evaluation of a New Smoke Extractor System in the Surgical Unit
An observational study of Lung Cancer and Lung Injury, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
The investigators will define two separate groups of surgical procedures: 1.) an 'open group' in which mainly open anatomic lung resections will be included, and 2.) a 'minimally invasive' group in which mainly thoracoscopic anatomic lung resections will be included. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Lung Cancer, Lung Injury
- What is being tested?
- Smoke evacuation system
- Type of treatment
- Medical device
- How many people
- 142 participants
- Where
- 1 siteSwitzerland
- Study dates
- 13 May 2019to 9 Sep 2019
- 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 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All surgical procedures that will be performed during the study period at the investigators' department will be randomly allocated to either the performance of surgery with or the performance of surgery without the use of a mobile smoke evacuation device. Whether the procedure will be performed open or minimally invasive will be decided by the operating surgeon and is not part of the randomization process. During the respective surgeries, a mass spectrometer will be used to measure the smoke concentrations and its composition in the operating room.
Who may be able to join
- All surgical procedures with a planned duration of more than 1 hour
Who cannot join
- Patients with a contraindication for electrocautery use
- Patients with Pacemaker or implantable cardioverter-defibrillator (ICD)
- Patients with an implanted neurostimulator device
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Hazardous Surgical Smoke: Risk Assessment and Evaluation of a New Smoke Extractor System (SES) in the Surgical Unit
The investigators will define two separate groups of surgical procedures: 1.) an 'open group' in which mainly open anatomic lung resections will be included, and 2.) a 'minimally invasive' group in which mainly thoracoscopic anatomic lung resections will be included.
Both groups will then be randomized to either the performance of the surgical procedure under 'standard conditions' or to the performance of the procedure with the additional use of a smoke evacuation system.
During every procedure the hazardous smoke that is generated by the electrocautery in the surgical field will be collected through a tube at the height of the surgeons face. The smoke is then directly transferred to a mass spectrometer that is situated in the operating room (OR) and performs a real-time analysis of the chemical substances in the air. The degree of air pollution will be measured as well as the smoke evacuation systems' ability to reduce these hazardous chemical substances in the air can be evaluated.
Read the detailed description
Smoke samples will be continuously analyzed with a latest generation time of flight mass spectrometer in real time. Concerning the smoke evacuation device, the investigators will use the model IES 2 (Intelligent Evacuation System) from Erbe Swiss medical for this study.
Since this is only an observational study in which the investigators are only recording the type of surgery (i.e. open oder minimally invasive) and not recording sensitive patient data, the local ethics committee waived the need for an ethics committee approval of the study. In the end the smoke evacuation system does not have an effect on the patient or the procedure itself, but may rather influence the concentration of hazardous surgical fumes in the operating theatre.
- Conditions
- Lung Cancer, Lung Injury
- Being tested
- Smoke evacuation system
- Keywords
- Smoke, Plume, Electrocautery, Mass spectrometer
- Medical subject headings
- Lung Neoplasms, Lung Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smoke evacuation systemDevice
The smoke evacuation system removes the surgical smoke directly near the electrocautery tip, where it is generated
| Study group | Role | What they receive |
|---|---|---|
| Minimally invasive surgery with smoke evacuation system (SES) | minimally invasive surgical procedures during which a smoke evacuation device is used Receives: Device: Smoke evacuation system | |
| Minimally invasive surgery without SES | minimally invasive surgical procedures during which no smoke evacuation device is used | |
| Open surgery with SES | open surgical procedures during which a smoke evacuation device is used Receives: Device: Smoke evacuation system | |
| Open surgery without SES | open surgical procedures during which no smoke evacuation device is used |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hazardous fumes - specifically the concentration of Furfural, Benzene and Butadiene
Analysis of surgical fume with real-time time of flight mass spectrometry
Measured: assessment of measurement will start 4 months after the project is started and will take up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2019
- Study start13 May 2019
- Primary completion9 Sep 2019
- Study completion9 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe 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
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Collaborators
- Tofwerk AG, Thun Switzerland (equipment, data analysis), Lungenliga Bern (main funding), Erbe Swiss AG (equipment)
- Responsible party
- Sponsor
- Investigators
- Gregor J Kocher, PD, MD, Principal investigator, Division of Thoracic Surgery, University Hospital Bern, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03924206
- Sponsor's protocol ID
- SurgicalSmoke1
- Status last verified
- Oct 2019
- First submitted
- 9 Apr 2019
- Last updated
- 3 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kocher GJ, Sesia SB, Lopez-Hilfiker F, Schmid RA. Surgical smoke: still an underestimated health hazard in the operating theatre. Eur J Cardiothorac Surg. 2019 Apr 1;55(4):626-631. doi: 10.1093/ejcts/ezy356.
PubMed 30388210Kocher GJ, Koss AR, Groessl M, Schefold JC, Luedi MM, Quapp C, Dorn P, Lutz J, Cappellin L, Hutterli M, Lopez-Hilfiker FD, Al-Hurani M, Sesia SB. Electrocautery smoke exposure and efficacy of smoke evacuation systems in minimally invasive and open surgery: a prospective randomized study. Sci Rep. 2022 Mar 23;12(1):4941. doi: 10.1038/s41598-022-08970-y.
PubMed 35322134
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hazardous Surgical Smoke: Risk Assessment and Evaluation of a New Smoke Extractor System (SES) in the Surgical Unit
- ClinicalTrials.gov ID
- NCT03924206
- Acronym / sponsor ID
- SurgicalSmoke1
- Conditions
- Lung Cancer, Lung Injury
- Keywords
- Smoke, Plume, Electrocautery, Mass spectrometer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Collaborators
- Tofwerk AG, Thun Switzerland (equipment, data analysis), Lungenliga Bern (main funding), Erbe Swiss AG (equipment)
- Study start
- 13 May 2019 (actual)
- Primary completion
- 9 Sep 2019 (actual)
- Study completion
- 9 Sep 2019 (actual)
- First posted
- 23 Apr 2019 (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.
The investigators will define two separate groups of surgical procedures: 1.) an 'open group' in which mainly open anatomic lung resections will be included, and 2.) a 'minimally invasive' group in which mainly thoracoscopic anatomic lung resections will be included.
Both groups will then be randomized to either the performance of the surgical procedure under 'standard conditions' or to the performance of the procedure with the additional use of a smoke evacuation system.
During every procedure the hazardous smoke that is generated by the electrocautery in the surgical field will be collected through a tube at the height of the surgeons face. The smoke is then directly transferred to a mass spectrometer that is situated in the operating room (OR) and performs a real-time analysis of the chemical substances in the air. The degree of air pollution will be measured as well as the smoke evacuation systems' ability to reduce these hazardous chemical substances in the air can be evaluated.
Detailed description
Smoke samples will be continuously analyzed with a latest generation time of flight mass spectrometer in real time. Concerning the smoke evacuation device, the investigators will use the model IES 2 (Intelligent Evacuation System) from Erbe Swiss medical for this study.
Since this is only an observational study in which the investigators are only recording the type of surgery (i.e. open oder minimally invasive) and not recording sensitive patient data, the local ethics committee waived the need for an ethics committee approval of the study. In the end the smoke evacuation system does not have an effect on the patient or the procedure itself, but may rather influence the concentration of hazardous surgical fumes in the operating theatre.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Minimally invasive surgery with smoke evacuation system (SES) | – | Device: Smoke evacuation systemminimally invasive surgical procedures during which a smoke evacuation device is used |
| Minimally invasive surgery without SES | – | –minimally invasive surgical procedures during which no smoke evacuation device is used |
| Open surgery with SES | – | Device: Smoke evacuation systemopen surgical procedures during which a smoke evacuation device is used |
| Open surgery without SES | – | –open surgical procedures during which no smoke evacuation device is used |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All surgical procedures that will be performed during the study period at the investigators' department will be randomly allocated to either the performance of surgery with or the performance of surgery without the use of a mobile smoke evacuation device. Whether the procedure will be performed open or minimally invasive will be decided by the operating surgeon and is not part of the randomization process. During the respective surgeries, a mass spectrometer will be used to measure the smoke concentrations and its composition in the operating room.
Key inclusion criteria (1 listed)
- All surgical procedures with a planned duration of more than 1 hour
Key exclusion criteria (3 listed)
- Patients with a contraindication for electrocautery use
- Patients with Pacemaker or implantable cardioverter-defibrillator (ICD)
- Patients with an implanted neurostimulator device
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 evacuation systemThe smoke evacuation system removes the surgical smoke directly near the electrocautery tip, where it is generated | Device | Minimally invasive surgery with smoke evacuation system (SES), Open surgery with SES |
Primary outcome
Hazardous fumes - specifically the concentration of Furfural, Benzene and Butadiene
Time frame: assessment of measurement will start 4 months after the project is started and will take up to 12 weeks
Analysis of surgical fume with real-time time of flight mass spectrometry
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 3 Oct 2019.
- Background: PubMed 30388210Kocher GJ, Sesia SB, Lopez-Hilfiker F, Schmid RA. Surgical smoke: still an underestimated health hazard in the operating theatre. Eur J Cardiothorac Surg. 2019 Apr 1;55(4):626-631. doi: 10.1093/ejcts/ezy356.
- Derived from this study: PubMed 35322134Kocher GJ, Koss AR, Groessl M, Schefold JC, Luedi MM, Quapp C, Dorn P, Lutz J, Cappellin L, Hutterli M, Lopez-Hilfiker FD, Al-Hurani M, Sesia SB. Electrocautery smoke exposure and efficacy of smoke evacuation systems in minimally invasive and open surgery: a prospective randomized study. Sci Rep. 2022 Mar 23;12(1):4941. doi: 10.1038/s41598-022-08970-y.
- 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.
Gregor J Kocher, PD, MD principal investigator
Division of Thoracic Surgery, University Hospital Bern, Switzerland
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 Lung Cancer and Lung Injury, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
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 3 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 3 Oct 2019. 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 Switzerland. 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?
Hazardous fumes - specifically the concentration of Furfural, Benzene and Butadiene (time frame: assessment of measurement will start 4 months after the project is started and will take up to 12 weeks). 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 NCT03924206, which also lists 2 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 3 Oct 2019.