BIS-Guided Sedation Monitoring

BIS-Guided Sedation Monitoring: A Prospective Randomized Study

This study looks to assess whether monitoring sedation status in mechanically-ventilated Medical Surgical Intensive Care Unit (MSICU) patients using Bispectral index (BIS) monitor-augmented sedation monitoring as opposed to Richmond Agitation Sedation Scale (RASS) score is associated with decreased duration of mechanical ventilation.

Investigators hypothesize that using BIS monitors to help monitor depth of sedation in mechanically ventilated ICU patient will result in a decreased duration of mechanical ventilation when compared to solely utilizing clinical sedation scales such as RASS.

Study Overview

• Status: Terminated
• Conditions: Patients Who Are Mechanically Ventilated and Sedated
• Intervention / Treatment: Other: sedation monitoring with RASS score; Other: sedation monitoring with BIS-Guided monitoring

Detailed Description

Participants will be randomized into two groups, the intervention group will receive sedation monitoring with BIS monitoring plus RASS. The control group will receive sedation monitoring with RASS score only. Randomization will be accomplished through online randomization software.

For randomization purposes, the intervention group will be labeled as the "A" group. The control group will labeled as the "B" group. In the BIS-augmented group, sedation requirement will be titrated according to an average of BIS reading in the 5 minute period prior to assessment with a goal of maintaining a value of (60-70) in addition to a RASS score goal of (-1 to -2), provided no noxious stimulation such as endotracheal suctioning and/or wound dressing has occurred for at least 30 minutes, BIS values have been stable for at least 5 minutes, signal quality index (>80%), minimal EMG interference (<50%), patient is not shivering, and patient does not have warmer or other devices that may produce an electric current on their body or nearby. In the RASS group, sedation requirements will be titrated to maintain a RASS score of (-1 to -2), will be assessed via the nurse taking care of the patient provided no noxious stimulation has occurred for at least 30 minutes prior to assessment.

Both groups will have sedation assessment at least every 6 hours during a 12 hour shift and as needed as per ICU RN and/or physician. Nurses will be free to exercise their judgment if they deem that their patients require more or less sedation that is inconsistent with patient's BIS or RASS score, they will, however, be required to provide a rationale for their judgment and record such events on a special form created for this study.

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Englewood, New Jersey, United States, 07631
      • Englewood Hospital and Medical Center

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:

• Patients >18 years of age.
• Patients expected to be mechanically ventilated and sedated with continuous intravenous infusions of Propofol or Midazolam and fentanyl for >= 24 hours within 12 hours of screening.

Exclusion Criteria:

• Patients with Seizure disorders acute neurological injury, severe dementia or anoxic brain injury.
• Patients with tracheostomies.
• Patients requiring neuromuscular blocking agents (NMBA).
• Patients transferred from another ICU while mechanically ventilated.
• Patients with cardiac pacemakers.
• Peri-cardiac arrest patients.
• Patients with induced hypothermia.
• Pregnant patients.
• Patients with no known Legally Authorized Representative (LAR).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Intevention Group; sedation monitoring with RASS score plus sedation monitoring with BIS-Guided monitoring	Other: sedation monitoring with RASS score; Other: sedation monitoring with BIS-Guided monitoring
Other: Control Group; sedation monitoring with RASS score	Other: sedation monitoring with RASS score

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
duration of mechanical ventilation	from enrollment to extubation, an expected average of 4 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
total sedation medication dose		from enrollment until extubation, an expected average of 4 days
undersedation	measured by self-initiated medical support device removal, time in hours spent in physical restraints, or ventilator asynchrony	from enrollment to extubation, an expected average of 4 days

Collaborators and Investigators

• Sponsor: Englewood Hospital and Medical Center

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: January 22, 2014
• First Submitted That Met QC Criteria: January 23, 2014
• First Posted (Estimate): January 27, 2014

Study Record Updates

• Last Update Posted (Estimate): February 19, 2016
• Last Update Submitted That Met QC Criteria: February 18, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Keywords: sedation; BIS; monitoring
• Other Study ID Numbers: E-13-519