J80 J81
Conditions
Interventions
Group 1: Inhalation Sedation with Isoflurane (target range -1 to -4 according to Richmond Agitation and Sedation Scale)
Group 2: Intravenous Sedation with Propofol (target range -1 to -4 according to
Sponsors
Sedana Medical AB
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Participation in Isoconda-Trial ("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") plus PaO2/FiO2-ratio < 300 at baseline Inclusion criteria for the main study called "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": 1. Male or female subjects, = 18 years (18 or older) 2. Continuous invasive ventilation and sedation = 48 hours (48 hours or less) at start of study sedation 3. Clinically likely to need invasive ventilation and sedation = 24 hours (24 hours or more) at randomisation 4. Ongoing sedation with propofol at time of randomisation 5. Prescribed target sedation depth within the RASS range -1 to -4 6. Signed informed consent or emergency situation inclusion criteria fulfilled and documented.
Exclusion criteria
Exclusion criteria: Exclusion criteria for Isoconda-trial plus extubation less than 36 hours after randomisation unavailability of arterial blood gas sample at end of study sedation (48+-12 hours after randomization). Exclusion criteria for the main study called "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" 1. Has not reached prescribed target sedation depth any time within the last 8 hours at randomisation 2. History of or genetic predisposal for malignant hyperthermia 3. Uncompensated acute circulatory failure at time of randomisation (MAP < 55 mmHg despite iv fluids and vasopressors). 4. Hepatic impairment of classification C according to the Child-Pugh score (Cholongitas et al., 2005). 5. Any for the study, relevant clinically significant abnormalities in clinical chemistry or haematology results at the time of screening, precluding study participation, as judged by the investigator 6. Acute neuropathology without ICP monitoring, including but not limited to stroke, neurosurgery and head trauma. 7. Planned anaesthesia or surgery within 24 hours from randomisation 8. Tidal volume < 350 ml 9. History of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject’s ability to participate in the study 10. Need for continuous muscle relaxation at the time of randomisation 11. Positive pregnancy test in women 12. History of allergy/hypersensitivity to isoflurane or propofol 13. Known participation in any other clinical study that included drug treatment within three months of the first administration of investigational product 14. Documented limitation of medical treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in PaO2/FiO2-ratio between baseline and end of study sedation (at 48+-12 hours after randomisation). | — |
Secondary
| Measure | Time frame |
|---|---|
| • 30-day mortality • Ventilator-free days alive during first 30 days after randomization • arterial partial pressure of carbon dioxide (PaCO2) at end of study sedation • pH at end of study sedation • PaO2/FiO2 – ratio (worst value within 24 hours) at day 5 of the 7-day-follow-up (corresponding to day 7 after randomization) • time to extubation in 30-day-survivors (use censoring in Kaplan-Meier-Diagram) | — |
Countries
Germany, Slovenia
Contacts
Public ContactTobias Becher
Klinik für Anästhesiologie und Operative Intensivmedizin, Universitätsklinikum Schleswig-Holstein, Campus Kiel
Outcome results
None listed