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Purpose

The purpose of this study is to determine the difference in the duration of mechanical ventilation, to evaluate the difference in ICU length of stay and to determine the difference in the overall dose of sedation medications between the between participants who were monitored using Bispectral index monitoring (BIS) monitors and those who were not.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Admission to the medical ICU - Intubated on mechanical ventilation - On sedation medication infusion

Exclusion Criteria

  • Patients with a history of chronic opioid use - Patients with end-stage liver disease at ICU admission (i.e., International normalized ratio >1.5 and not taking warfarin and/or a total serum bilirubin 1.5 times above normal limits) - Pregnant patients - Current prisoner - Refractory shock: Mean arterial blood pressure below 65 millimeters of mercury(65mmHg) despite maximum doses of 3 pressors. Norepinephrine 70mcg/min; vasopressin 0.03 units/min; epinephrine 35mcg/min; dopamine 20mcg/kg/min and phenylephrine 350mcg/min - Inability to complete the required time for follow-up - Surgical admission diagnosis - Patients with skin conditions precluding BIS monitor sensor adherence - Patients on neuromuscular blockade infusion or benzodiazepine infusion

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Prevention
Masking
Single (Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
BIS group
  • Device: BIS group
    Participants will be placed on BIS monitoring continuously until extubation, transfer to another facility, change in status to comfort measures, or if the patient expires. The BIS monitoring system offers a continuous processed electroencephalographic measurement used to assess cerebral activity and can monitor the electrophysiologic effects of sedation and anesthetics.BIS monitoring offers numerical values which have been validated to reflect various sedation levels. BIS levels range from 0 to 100 with greater than 100 corresponding to wakefulness. Values less than 60 indicate deep sedation and values less than 40 correspond to deep anesthesia
  • Other: Non-BIS group
    The usual protocol for titrating sedation will be followed using various sedation assessment scales such as Richmond Agitation Sedation Scale (RASS), Visual Analog Scale (VAS), Ramsay Sedation Scale (RSS), or Sedation Agitation Scale (SAS) per physicians choice.
Active Comparator
Non-BIS group
  • Other: Non-BIS group
    The usual protocol for titrating sedation will be followed using various sedation assessment scales such as Richmond Agitation Sedation Scale (RASS), Visual Analog Scale (VAS), Ramsay Sedation Scale (RSS), or Sedation Agitation Scale (SAS) per physicians choice.

Recruiting Locations

Memorial Hermann Cypress Hospital
Cypress, Texas 77433
Contact:
Pascal L Kingah, MD, MPH
713-500-6828
Pascal.L.Kingah@uth.tmc.edu

More Details

Status
Recruiting
Sponsor
The University of Texas Health Science Center, Houston

Study Contact

Pascal L Kingah, MD, MPH
713 500 6828
Pascal.L.Kingah@uth.tmc.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.