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

NCT03250481 | Completed

• 1 other identifier: HelsinkiUCHFin
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Critical Illness

Keywords

Sedation, Responsiveness Index, Electromyogram

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Increased ventilator free days

  30 days

Study Arms (2)

'Sedation guidance with RASS-group

ACTIVE COMPARATOR

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 guidance with RI

EXPERIMENTAL

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

Interventions

Propofol DRUG

Sedation targeted to RASS -3-0 or RI 20-40

Also known as: Oxycodone, Midazolame

'Sedation guidance with RASS-group; 'Sedation guidance with RI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Intensive care patients
• Need of mechanical ventilation and sedation

You may not qualify if:

• contraindication to propofol or oxycodone
• hypoxic or traumatic brain injury
• intracranial hemorrhage
• status epilepticus
• drug overdose as admission diagnosis

Sponsors & Collaborators

• Helsinki University Central Hospital: lead

Study Sites (1)

HelsinkiUCH

Helsinki, Finland

Location

MeSH Terms

Conditions

Critical Illness

Interventions

Propofol; Oxycodone

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Johanna Wennervirta, MD, PhD

  University of Helsinki and Helsinki University Hospital, PO Box 340, 00029 Helsinki, Finland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 8, 2017
• First Posted: August 15, 2017
• Study Start: March 1, 2013
• Primary Completion: August 28, 2017
• Study Completion: August 28, 2017
• Last Updated: August 15, 2019

Record last verified: 2019-08

Locations

FI (1)