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

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.

Study Overview

• Status: Completed
• Conditions: Lung Cancer; Lung Injury
• Intervention / Treatment: Device: Smoke evacuation system

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 Type: Observational
• Enrollment (Actual): 142

Contacts and Locations

Study Locations

• Switzerland
  • Bern, Switzerland, 3010
    • University Hospital Bern

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Minimally invasive surgery with smoke evacuation system (SES); minimally invasive surgical procedures during which a smoke evacuation device is used	Device: Smoke evacuation system; The smoke evacuation system removes the surgical smoke directly near the electrocautery tip, where it is generated
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	Device: Smoke evacuation system; The smoke evacuation system removes the surgical smoke directly near the electrocautery tip, where it is generated
Open surgery without SES; open surgical procedures during which no smoke evacuation device is used

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University Hospital Inselspital, Berne
• Collaborators: Tofwerk AG, Thun Switzerland (equipment, data analysis); Lungenliga Bern (main funding); Erbe Swiss AG (equipment)
• Investigators: Principal Investigator: Gregor J Kocher, PD, MD, Division of Thoracic Surgery, University Hospital Bern, Switzerland

Publications and helpful links

General 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. Erratum In: Eur J Cardiothorac Surg. 2019 Apr 1;55(4):803.
• Kocher 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 13, 2019
• Primary Completion (Actual): September 9, 2019
• Study Completion (Actual): September 9, 2019

Study Registration Dates

• First Submitted: April 9, 2019
• First Submitted That Met QC Criteria: April 17, 2019
• First Posted (Actual): April 23, 2019

Study Record Updates

• Last Update Posted (Actual): October 3, 2019
• Last Update Submitted That Met QC Criteria: October 2, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: Smoke; Plume; Electrocautery; Mass spectrometer
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Wounds and Injuries; Thoracic Injuries; Lung Injury
• Other Study ID Numbers: SurgicalSmoke1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No