Outcome after prolonged sedation - IsoOut-Study

Sedana Medical AB0 sites301 target enrollmentJanuary 7, 2020

Overview

No summary available.

Registry

who.int

Start Date

January 7, 2020

End Date

January 12, 2020

Last Updated

last year

Study Type

Interventional

Sex

All

Sponsor

•IsoConDa Study plus
•Ventilation for more than 96 hours
•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.

•IsoConDa Study
•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