Responsiveness Index Versus the RASS Based Method for Adjusting Sedation in Critically Ill Patients

• Status: Completed
• Trial end date: 2017-08-28
• Target enrollment: 0
• Participant gender: All

Summary

Systematic evaluation of pain, agitation and delirium in ICU-patients is recommended and deep sedation should be avoided. Sedation is still monitored with clinical assessments, like RASS. The Responsiveness Index (RI) is a recently described method for ICU sedation monitoring. It is based on processed frontal EMG and reflects the interaction between a patient's conscious state and the intensity and frequency of stimulations during treatment. RI has not been randomly compared to RASS to titrate sedation to target at a clinically adequate sedation state. In this open randomized controlled pilot study of 32 critically ill, mechanically ventilated adult patients, investigators will evaluate the feasibility, safety and efficacy of RI based sedation compared to standard RASS based titration of sedation. Investigators hypothesize first that RI controlled sedation will be safe and, second that RI controlled sedation will associate with increased number of ventilator free days alive in 30 days without excess adverse events.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Helsinki University Central Hospital
• Treatments: Oxycodone; Propofol

Criteria

Inclusion Criteria:

• Intensive care patients

• Need of mechanical ventilation and sedation

Exclusion Criteria:

• contraindication to propofol or oxycodone

• hypoxic or traumatic brain injury

• intracranial hemorrhage

• status epilepticus

• drug overdose as admission diagnosis