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

Completed

• Conditions: Lung Cancer; Lung Injury
• Interventions: Device: Smoke evacuation system

• Registration Number: NCT03924206
• Lead Sponsor: Insel Gruppe AG, University Hospital Bern

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.

Study Timeline

• Study First Submitted: 2019-04-09
• Study First Submitted QC: 2019-04-17
• Study First Posted: 2019-04-23
• Study Start: 2019-05-13
• Primary Completion: 2019-09-09
• Study Completion: 2019-09-09
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-02
• Last Update Posted: 2019-10-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 142

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Open surgery with SES	Smoke evacuation system	open surgical procedures during which a smoke evacuation device is used
Minimally invasive surgery with smoke evacuation system (SES)	Smoke evacuation system	minimally invasive surgical procedures during which a smoke evacuation device is used

Primary Outcome Measures

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

Trial Locations

Locations (1)

University Hospital Bern; 🇨🇭 Bern, Switzerland