Clinical trial NCT02045927: BIS-Guided Sedation Monitoring
Official title: BIS-Guided Sedation Monitoring: A Prospective Randomized Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Patients Who Are Mechanically Ventilated and Sedated
Keywords: sedation
BIS
monitoring
Lead sponsor: Englewood Hospital and Medical Center
Sponsor class: OTHER
First posted: 2014-01-27
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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: 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.

Eligibility criteria: 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).

Primary outcomes:
measure: duration of mechanical ventilation
timeFrame: from enrollment to extubation, an expected average of 4 days
Secondary outcomes:
measure: total sedation medication dose
timeFrame: from enrollment until extubation, an expected average of 4 days
measure: undersedation
timeFrame: from enrollment to extubation, an expected average of 4 days
Other outcomes:
Locations:
city: Englewood
country: United States
facility: Englewood Hospital and Medical Center
state: New Jersey
Study officials:
affiliation: Englewood Hospital and Medical Center
name: Carmine Gianatiempo, MD
role: PRINCIPAL_INVESTIGATOR
References: