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Completed

NCT Number: NCT03250481

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.

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Key information

Conditions

Critical Illness Disease Attributes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

HelsinkiUCH

Helsinki, Finland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Propofol

Drug

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

Other names: Oxycodone, Midazolame

Primary outcomes

  1. Number of patients with sedation or sedation monitoring related predetermined adverse events

    Time frame: Up to 96 hours (starting when RI-monitoring begins)

    Predetermined adverse events hypotension, hypertension, tachycardia, tachypnea, anxiety, unintended catheter removal, gas exchange deficiency, skin irritation caused by electrodes, hemodynamic instability

Secondary outcomes

  1. Increased ventilator free days

    Time frame: 30 days

    Time alive without mechanical ventilation

Sponsors and collaborators

Lead sponsor

Helsinki University Central Hospital

Other

Registry information

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Aug 15, 2017
Registry last updated
Aug 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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