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

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.

Study Overview

• Status: Completed
• Conditions: Critical Illness
• Intervention / Treatment: Drug: Propofol

Detailed Description

Sedation of intensive care patients is needed for patient's safety but deep sedation is associated with adverse outcomes. Frontal electromyogram based Responsiveness Index (RI) aims to quantify patient's arousal. RI monitoring together with staff education may have potential to improve sedation quality. Investigators will evaluate the safety of RI based sedation versus standard care using Richmond Agitation-Sedation Scale (RASS) for sedation.

Methods: randomized study, critically ill adult patients with mechanical ventilation and administration of sedation to either RI- or RASS-guided sedation. Propofol (and midazolam combined with if needed) as a hypnotic drug and oxycodone as an analgesic drug. Investigators will follow standardized sedation protocol in both groups to achieve the predetermined target sedation level: either RI 40-80 (RI-group) or RASS -3-0 (RASS group). RI measurement is continuous in both groups, but blinded in the RASS group. Accordingly, RI group is blinded to RASS assessments. State Entropy (SE) will register in both groups.

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Finland
  • Helsinki, Finland
    • HelsinkiUCH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 'Sedation guidance with RASS-group; Sedation is guided with RASS. Targeted sedation level is RASS -3 - 0. Propofol: an initial rate of 2.4 mg/kg/h for one hour. Thereafter, the infusion rate of propofol is 0.8-4 mg/kg/h to reach or maintain the target RASS score. Propofol bolus of 20-40 mg is allowed. Oxycodone as 3-6 mg boluses for pain management. Other opiates are not allowed. Midazolam may given if the maximum dose of propofol is reached and pain management by oxycodone restricted achievement of the target sedation level. Midazolam will supply intravenously in boluses of 1-2 mg (based on the weight of the patient), starting at 3 boluses/h for the first hour. Dexmedetomidine and other sedatives are not allowed.	Drug: Propofol; Sedation targeted to RASS -3-0 or RI 20-40; Other Names: Oxycodone; Midazolame
Experimental: 'Sedation guidance with RI; Sedation is guided with RI. Targeted sedation level is RI 40-80. Propofol: an initial rate of 2.4 mg/kg/h for one hour. Thereafter, the infusion rate of propofol is 0.8-4 mg/kg/h to reach or maintain the target RI score. Propofol bolus of 20-40 mg is allowed. Oxycodone as 3-6 mg boluses for pain management. Other opiates are not allowed. Midazolam may given if the maximum dose of propofol is reached and pain management by oxycodone restricted achievement of the target sedation level. Midazolam will supply intravenously in boluses of 1-2 mg (based on the weight of the patient), starting at 3 boluses/h for the first hour. Dexmedetomidine and other sedatives are not allowed.	Drug: Propofol; Sedation targeted to RASS -3-0 or RI 20-40; Other Names: Oxycodone; Midazolame

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients with sedation or sedation monitoring related predetermined adverse events	Predetermined adverse events hypotension, hypertension, tachycardia, tachypnea, anxiety, unintended catheter removal, gas exchange deficiency, skin irritation caused by electrodes, hemodynamic instability	Up to 96 hours (starting when RI-monitoring begins)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Increased ventilator free days	Time alive without mechanical ventilation	30 days

Collaborators and Investigators

• Sponsor: Helsinki University Central Hospital
• Investigators: Principal Investigator: Johanna Wennervirta, MD, PhD, University of Helsinki and Helsinki University Hospital, PO Box 340, 00029 Helsinki, Finland

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2013
• Primary Completion (Actual): August 28, 2017
• Study Completion (Actual): August 28, 2017

Study Registration Dates

• First Submitted: August 8, 2017
• First Submitted That Met QC Criteria: August 11, 2017
• First Posted (Actual): August 15, 2017

Study Record Updates

• Last Update Posted (Actual): August 15, 2019
• Last Update Submitted That Met QC Criteria: August 13, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: Sedation, Responsiveness Index, Electromyogram
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Hypnotics and Sedatives; Propofol; Oxycodone
• Other Study ID Numbers: HelsinkiUCHFin

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No