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

NCT ID: NCT03924206

Last Updated: 2019-10-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 142 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-05-13
• Study Completion Date: 2019-09-09

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.

Conditions

Lung Cancer; Lung Injury

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Minimally invasive surgery with smoke evacuation system (SES)

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

Smoke evacuation system

Intervention Type: DEVICE

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

No interventions assigned to this group

Open surgery with SES

open surgical procedures during which a smoke evacuation device is used

Smoke evacuation system

Intervention Type: DEVICE

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

No interventions assigned to this group

Interventions

Smoke evacuation system

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Tofwerk AG, Thun Switzerland (equipment, data analysis)

UNKNOWN

Sponsor Role: collaborator

Lungenliga Bern (main funding)

UNKNOWN

Sponsor Role: collaborator

Erbe Swiss AG (equipment)

UNKNOWN

Sponsor Role: collaborator

Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gregor J Kocher, PD, MD

Role: PRINCIPAL_INVESTIGATOR

Division of Thoracic Surgery, University Hospital Bern, Switzerland

Locations

University Hospital Bern

Bern, , Switzerland

Countries

Switzerland

References

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.

Reference Type: BACKGROUND

PMID: 30388210 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 35322134 (View on PubMed)

Other Identifiers

SurgicalSmoke1

Identifier Type: -

Identifier Source: org_study_id