Sedation
Conditions
Keywords
sedation, Bispectral Monitoring
Brief summary
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.
Interventions
DEVICEBIS 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
OTHERNon-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.
Sponsors
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Median ventilator time reported in hours | from the time the patient was intubated to the time they were extubated, changed to comfort measures, transferred to another facility, or expired(about 4-6 days) |
Secondary
| Measure | Time frame |
|---|---|
| ICU length of stay | During ICU discharge or transfer out of ICU (about 5-7 days after admission to ICU) |
| Amount of sedation medication used | From start of ventilation to end of ventilation (about 4-6 days) |
Countries
United States
Contacts
CONTACTPascal L Kingah, MD, MPH
CONTACTElizabeth Vidales
PRINCIPAL_INVESTIGATORPascal L Kingah, MD, MPH
The University of Texas Health Science Center, Houston
Outcome results
None listed