BIS-Guided Sedation Monitoring

Stopped early · Not applicable

Conditions studied: Patients Who Are Mechanically Ventilated and Sedated

In brief

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.

Key facts

Study ID

NCT02045927

Run by

Englewood Hospital and Medical Center

People needed

19

Starts

2014-01-01

Expected to finish

2015-12-01

Last updated by the study team

2016-02-19

Who can join

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

You may qualify if…

• 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.

You may not qualify if…

• 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).

Where it is running

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

Full record on ClinicalTrials.gov

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