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

NCT03924206 | Completed

• 1 other identifier: SurgicalSmoke1
• Study Type: observational
• Target: 142
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer; Lung Injury

Keywords

Smoke; Plume; Electrocautery; Mass spectrometer

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (4)

Minimally invasive surgery with smoke evacuation system (SES)

minimally invasive surgical procedures during which a smoke evacuation device is used

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

Device: Smoke evacuation system

Open surgery without SES

open surgical procedures during which no smoke evacuation device is used

Interventions

Smoke evacuation system DEVICE

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

Minimally invasive surgery with smoke evacuation system (SES); Open surgery with SES

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead
• Tofwerk AG, Thun Switzerland (equipment, data analysis): collaborator
• Lungenliga Bern (main funding): collaborator
• Erbe Swiss AG (equipment): collaborator

Study Sites (1)

University Hospital Bern

Bern, 3010, Switzerland

Location

Related Publications (2)

• 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.

  PMID: 30388210 BACKGROUND

• 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.

  PMID: 35322134 DERIVED

MeSH Terms

Conditions

Lung Neoplasms; Lung Injury

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Thoracic Injuries; Wounds and Injuries

Study Officials

• Gregor J Kocher, PD, MD

  Division of Thoracic Surgery, University Hospital Bern, Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2019
• First Posted: April 23, 2019
• Study Start: May 13, 2019
• Primary Completion: September 9, 2019
• Study Completion: September 9, 2019
• Last Updated: October 3, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)