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

Critical Illness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03250481
• Other study ID #: HelsinkiUCHFin
• Status: Completed
• Phase: N/A
• Start date: March 2013
• Est. completion date: August 28, 2017

Study information

• Verified date: August 2019
• Source: Helsinki University Central Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: August 28, 2017
• Est. primary completion date: August 28, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Critical Illness

Intervention

Drug:
• Propofol
Sedation targeted to RASS -3-0 or RI 20-40

Locations

Country	Name	City	State
Finland	HelsinkiUCH	Helsinki

Sponsors (1)

Lead Sponsor	Collaborator
Helsinki University Central Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Increased ventilator free days	Time alive without mechanical ventilation	30 days