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Completed

NCT Number: NCT00734409

Combining Objective and Subjective Sedation Assessment Tools

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University Health System

Durham, North Carolina, 27710, United States

About this study

Patients in the intensive care unit (ICU) who require a ventilator to help them breathe also require sedation in order to keep them comfortable and prevent injury. The national guidelines for sedation management include a daily interruption of sedation performed once each morning. To determine the amount of sedation needed, the current standard practice is to use a system called the Richmond Agitation-Sedation Scale (RASS). The patient is stimulated by calling their name or by tapping their shoulder until the patient's responses indicate that a satisfactory level of sedation has been achieved.

The purpose of this study is to determine if the use of a device called the BIS monitor in addition to the RASS will give better assessment of a subject's level of sedation. The BIS monitor is a sensor strip taped to the forehead and attached to a device that reads electrical activity from the brain. It is approved by the U.S. Food and Drug Administration (FDA) for monitoring patients under sedation.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

  • 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)

Treatment and study plan

Bispectral Index (BIS) Monitor

Device

BIS monitoring in addition to RASS assessments

Other names: Richmond agitation sedation scale, neurofunction monitor

Primary outcomes

  1. Mean Sedative Use

    Time frame: Intensive Care Unit (ICU) stay through discharge

    The mean amount of propofol used on each patient while the patient was in the ICU and receiving mechanical ventilation.

Secondary outcomes

  1. Unplanned Self-device Removal Events

    Time frame: ICU stay through discharge

    The number of unplanned self-device removal events that took place during the study period.

  2. Mean Days on Mechanical Ventilation

    Time frame: ICU stay- through discharge

    The mean number of days that the patients were on mechanical ventilation.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • Medtronic - MITG

Registry information

Official study title

Combining Objective and Subjective Sedation Assessment Tools - Second Study

Acronym: COST_2

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Aug 14, 2008
Registry last updated
Mar 29, 2013

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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