Hazardous Surgical Smoke: Risk Assessment and Evaluation of a New Smoke Extractor System 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.

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Key information

Conditions

Lung Cancer Lung Diseases Lung Injury Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Injuries Thoracic Neoplasms Wounds and Injuries

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Bern

Bern, 3010, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Smoke evacuation system

Device

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

Primary outcomes

Hazardous fumes - specifically the concentration of Furfural, Benzene and Butadiene

Time frame: 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

Sponsors and collaborators

Lead sponsor

Insel Gruppe AG, University Hospital Bern

Other

Collaborators

Erbe Swiss AG (equipment)
Lungenliga Bern (main funding)
Tofwerk AG, Thun Switzerland (equipment, data analysis)

Registry information

Official study title

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

Important dates

Study start: 2019
Primary completion: 2019
Study completion: 2019
First posted: Apr 23, 2019
Registry last updated: Oct 3, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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