Combining Objective and Subjective Sedation Assessment Tools

Completed · Not applicable

Conditions studied: Critical Illness

In brief

The purpose of this study is to determine if the use of a device called the BIS monitor in addition to the Richmond Agitation Sedation Scale will give better assessment of a subject's level of sedation.

Key facts

Study ID

NCT00734409

Run by

Duke University

People needed

300

Starts

2008-05-01

Expected to finish

2011-07-01

Last updated by the study team

2013-03-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• patient in the ICU
• continuous IV sedation with propofol midazolam or dexmedetomidine
• age > 18
• expected to require mechanical ventilation for >=48 hours

You may not qualify if…

• prisoners
• no available space on forehead
• continuous electroencephalography(EEG) monitoring
• bifrontal brain injury
• barbiturate coma therapy
• known hypersensitivity to study medications
• high risk for ethanol (ETOH) withdrawal
• resuscitation from cardiac arrest without recovery of mental status
• moribund clinical state (death expected within 48 hours)

Where it is running

• Duke University Health System — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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