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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03924206
Other study ID # SurgicalSmoke1
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 13, 2019
Est. completion date September 9, 2019

Study information

Verified date October 2019
Source University Hospital Inselspital, Berne
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 142
Est. completion date September 9, 2019
Est. primary completion date September 9, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 90 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Switzerland University Hospital Bern Bern

Sponsors (4)

Lead Sponsor Collaborator
University Hospital Inselspital, Berne Erbe Swiss AG (equipment), Lungenliga Bern (main funding), Tofwerk AG, Thun Switzerland (equipment, data analysis)

Country where clinical trial is conducted

Switzerland, 

References & Publications (1)

Kocher GJ, Sesia SB, Lopez-Hilfiker F, Schmid RA. Surgical smoke: still an underestimated health hazard in the operating theatre. Eur J Cardiothorac Surg. 2019 Apr 1;55(4):626-631. doi: 10.1093/ejcts/ezy356. — View Citation

Outcome

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