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

Insel Gruppe AG, University Hospital Bern

Status: Completed

Conditions: Lung Injury; Lung Cancer

Treatments: Device: Smoke evacuation system

Study type: Observational

Funder types: Other

Identifiers

NCT03924206

SurgicalSmoke1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 142 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

142 participants in 4 patient groups

Minimally invasive surgery with smoke evacuation system (SES)

Description:

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

Treatment:

Device: Smoke evacuation system

Minimally invasive surgery without SES

Description:

minimally invasive surgical procedures during which no smoke evacuation device is used

Open surgery with SES

Description:

open surgical procedures during which a smoke evacuation device is used

Treatment:

Device: Smoke evacuation system

Open surgery without SES

Description:

open surgical procedures during which no smoke evacuation device is used