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

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03924206
• Other study ID #: SurgicalSmoke1
• Status: Completed
• Start date: May 13, 2019
• Est. completion date: September 9, 2019

Study information

• Verified date: October 2019
• Source: University Hospital Inselspital, Berne
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 142
• Est. completion date: September 9, 2019
• Est. primary completion date: September 9, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Lung Cancer
• Lung Injury

Intervention

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

Locations

Country	Name	City	State
Switzerland	University Hospital Bern	Bern

Sponsors (4)

Lead Sponsor	Collaborator
University Hospital Inselspital, Berne	Erbe Swiss AG (equipment), Lungenliga Bern (main funding), Tofwerk AG, Thun Switzerland (equipment, data analysis)

Country where clinical trial is conducted

Switzerland, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hazardous fumes - specifically the concentration of Furfural, Benzene and Butadiene	Analysis of surgical fume with real-time time of flight mass spectrometry	assessment of measurement will start 4 months after the project is started and will take up to 12 weeks