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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/21/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/21/2021.

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

Clinicaltrials.gov identifier NCT03924206

Recruitment Status Completed

First Posted April 23, 2019

Last update posted October 3, 2019

Study Description

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.

  • Condition or Disease:Lung Injury
    Lung Cancer
  • Intervention/Treatment: Device: Smoke evacuation system
  • Phase: N/A
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 Design
  • Study Type: Observational
  • Actual Enrollment: 142 participants
  • Observational Model: Case-Control
  • Time Perspective: Prospective
  • Official Title: Hazardous Surgical Smoke: Risk Assessment and Evaluation of a New Smoke Extractor System (SES) in the Surgical Unit
  • Actual Study Start Date: May 2019
  • Actual Primary Completion Date: September 2019
  • Actual Study Completion Date: September 2019
Groups and Cohorts
Groups/Cohorts Intervention/treatment
: Minimally invasive surgery with smoke evacuation system (SES)
minimally invasive surgical procedures during which a smoke evacuation device is used
Device: Smoke evacuation system
The smoke evacuation system removes the surgical smoke directly near the electrocautery tip, where it is generated
: Open surgery with SES
open surgical procedures during which a smoke evacuation device is used
Device: Smoke evacuation system
The smoke evacuation system removes the surgical smoke directly near the electrocautery tip, where it is generated
Outcome Measures
  • Primary Outcome Measures: 1. 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
Eligibility Criteria
  • Ages Eligible for Study: 18 to 90 Years (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: Yes
  • 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.
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

Contacts and Locations
Contacts
Locations

Switzerland
University Hospital Bern
Bern

Sponsors and Collaborators

University Hospital Inselspital, Berne

Tofwerk AG, Thun Switzerland (equipment, data analysis)

Lungenliga Bern (main funding)

Erbe Swiss AG (equipment)

Investigators

Principal Investigator: Gregor J Kocher, PD, MD Division of Thoracic Surgery, University Hospital Bern, Switzerland

More Information