Clinical Studies (Phase III Clinical Study)


Phase III Clinical Study


A randomised, controlled, open-label study to confirm the efficacy and safety of sedation with isoflurane in invasively ventilated ICU patients using the AnaConDa administration system.

Patient Base
550

Number of Centres
20

Trial Period
2017 – 2018

Objective
To demonstrate that sedation with Isoflurane is non-inferior to Propofol in terms of maintaining adequate sedation without rescue sedation.

  • Evaluate safety profile of Isoflurane compared to Propofol in terms of experienced adverse events, biochemistry laboratory values, vital signs.
  • Evaluate wake-up time during daily sedation stops in the ICU for subjects sedated with Isoflurane compared to propofol.
  • Evaluate Isoflurane dosing in sedation.
  • Evaluate AnaConDa performance in administering Isoflurane for sedation in terms of experienced device deficiencies.
  • Evaluate rescue sedation administration in subjects sedated with Isoflurane compared to Propofol.
  • Evaluate vasopressor/inotropic agent administration in subjects sedated with Isoflurane compared to Propofol.
  • Evaluate use of analgesic agent and behavioural pain scale assessments in subjects sedated with Isoflurane compared to Propofol.
  • Evaluate ability to breathe spontaneous and applied ventilator mode in subjects sedated with Isoflurane compared to Propofol.
  • Evaluate the time to extubation for subjects sedated with Isoflurane compared to Propofol.

More Information:
https://www.clinicaltrialsregister.eu/ctr-search/trial/2016-004551-67/DE