Bispectral Monitoring on Mechanically Ventilated Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: BIS group, Non-BIS group.
- Who it may be relevant to
- Registry conditions: Sedation. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Bispectral Monitoring on Mechanically Ventilated Patients, a Randomized Clinical Trial. (BIMV Trial)
Overview
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
- 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 - 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.
Primary outcome measures
- Median ventilator time reported in hours [Time frame: 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 outcome measures (2)
- ICU length of stay [Time frame: During ICU discharge or transfer out of ICU (about 5-7 days after admission to ICU)]
- Amount of sedation medication used [Time frame: From start of ventilation to end of ventilation (about 4-6 days)]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Prevention
Study locations
United States · 1 center
- Memorial Hermann Cypress Hospital — Cypress
Identifiers
NCT: NCT07219069 · HSC-MS-25-0240