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

NCT03924206 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 142

Last updated 2019-10-03

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

Smoke evacuation system

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

Sponsors & Collaborators

  • Tofwerk AG, Thun Switzerland (equipment, data analysis)

    collaborator UNKNOWN

  • Lungenliga Bern (main funding)

    collaborator UNKNOWN

  • Erbe Swiss AG (equipment)

    collaborator UNKNOWN

  • Insel Gruppe AG, University Hospital Bern

    lead OTHER

Principal Investigators

  • Gregor J Kocher, PD, MD · Division of Thoracic Surgery, University Hospital Bern, Switzerland

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-05-13
Primary Completion
2019-09-09
Completion
2019-09-09

Countries

  • Switzerland

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03924206 on ClinicalTrials.gov