Prospective intervention study to determine the anesthesia workplace exposure to sevoflurane when using activated carbon filters vs. anesthesia gas scavenging systems. CONTRAGASS

Study type

• Study topic:
  Medical device
• Study type:
  Not applicable
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness
• If ‘Not applicable’, further details on the study type:
  Small amounts of anesthetic gas inevitably escape during anesthesia due to device-specific leaks and the gas's high volatility. ; Anesthetic gas is potentially harmful to health and the environment. ; Anesthetic gas scavenging systems ensure the lowest possible workplace exposure for medical personnel in the operating room. Innovative anesthetic gas absorbers can also achieve this and, as a passive system, have the advantage of avoiding high energy costs and reducing CO2 emissions. ; We compare the leakage of both systems using a measuring device for anesthetic gas in the room air.
• Data collection methods:
  No individual level data collected for the purpose of the study

Clinical trials

• Clinical trial regulatory scope:
  Post-authorisation interventional clinical trial
• Clinical trial randomisation:
  Randomised clinical trial

Population studied

• Short description of the study population:
  People over the Age of 18
• Age groups:
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)

      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)
• Special population of interest:
  Other
• Special population of interest, other:
  Patients from the departement of ophtamology
• Estimated number of subjects:
  20

Study design details

• Study design:
  We will measure the concentration of sevoflurane 20 common workdays in de Operationroom. We will randomly use for 10 days the common anesthetic gas scavenging system and 10 days the anesthetic gas absorbers CONTRAFLURAN.
• Main study objective:
  The concentration of sevoflurane in ppm in the operation room during anesthesia.
• Setting:
  We will measure the concentration of sevoflurane 20 common workdays in de Operationroom. We will randomly use for 10 days the common anesthetic gas scavenging system and 10 days the anesthetic gas absorbers CONTRAFLURAN.
• Interventions:
  The use of the anesthetic gas absorbers CONTRAFLURAN.
• Comparators:
  A common anesthetic gas scavenging system.
• Outcomes:
  1. The workplace exposure to sevoflurane is < 2 ppm on average over 8 hours in the test and control groups.; 2. Workplace exposure to sevoflurane does not differ between the test and control groups.