BIS-Guided Sedation Monitoring

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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BIS-Guided Sedation Monitoring: A Prospective Randomized Study

Conditions
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Patients Who Are Mechanically Ventilated and Sedated

Intervention / Treatment
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* Other: sedation monitoring with RASS score
* Other: sedation monitoring with BIS-Guided monitoring


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sedation, BIS, monitoring