RecruitingNot ApplicableNCT07219069

Bispectral Monitoring on Mechanically Ventilated Patients

Bispectral Monitoring on Mechanically Ventilated Patients, a Randomized Clinical Trial. (BIMV Trial)

Sponsor

The University of Texas Health Science Center, Houston

Enrollment

30 participants

Start Date

Nov 1, 2025

Study Type

INTERVENTIONAL

Conditions

Sedation

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria3

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

Exclusion Criteria9

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

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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.