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Hazardous Surgical Smoke: Risk Assessment and Evaluation of a New Smoke Extractor System in the Surgical Unit

Hazardous Surgical Smoke: Risk Assessment and Evaluation of a New Smoke Extractor System (SES) in the Surgical Unit

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03924206
Enrollment
142
Registered
2019-04-23
Start date
2019-05-13
Completion date
2019-09-09
Last updated
2019-10-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer, Lung Injury

Keywords

Smoke, Plume, Electrocautery, Mass spectrometer

Brief 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. 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.

Interventions

DEVICESmoke evacuation system

The smoke evacuation system removes the surgical smoke directly near the electrocautery tip, where it is generated

Sponsors

Tofwerk AG, Thun Switzerland (equipment, data analysis)
CollaboratorUNKNOWN
Lungenliga Bern (main funding)
CollaboratorUNKNOWN
Erbe Swiss AG (equipment)
CollaboratorUNKNOWN
Insel Gruppe AG, University Hospital Bern
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
Yes

Inclusion criteria

\- All surgical procedures with a planned duration of more than 1 hour

Exclusion criteria

* Patients with a contraindication for electrocautery use * Patients with Pacemaker or implantable cardioverter-defibrillator (ICD) * Patients with an implanted neurostimulator device

Design outcomes

Primary

MeasureTime frameDescription
Hazardous fumes - specifically the concentration of Furfural, Benzene and Butadieneassessment of measurement will start 4 months after the project is started and will take up to 12 weeksAnalysis of surgical fume with real-time time of flight mass spectrometry

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026