Bispectral Monitoring for Ventilated Patients

This study is looking at whether using a Bispectral Index (BIS) monitor, which measures brain activity, can help patients on a breathing machine (mechanical ventilation) get off the ventilator sooner. You could be eligible if you are an adult admitted to the medical ICU, on a breathing machine, and receiving sedation medication. The study aims to see if BIS monitoring changes how long you need the ventilator, your stay in the ICU, and the amount of sedation medicine you receive. The main goal is to compare the time patients spend on the ventilator. This study is currently unclear on its status and plans to enroll 30 participants.

Study design
This interventional study plans to enroll 30 participants. It compares patients who receive continuous BIS monitoring with those who receive standard sedation care.
What's involved
Participants will either have continuous BIS monitoring until they are taken off the breathing machine or transferred, or they will receive standard sedation care.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, ventilator time, is measured from intubation until extubation, transfer, or death (about 4-6 days).

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NCT07219069

Bispectral Monitoring on Mechanically Ventilated Patients

Recruiting
NAAges 18+InterventionalPrevention
The University of Texas Health Science Center, Houston
~30 participants
Updated 2026-06-25 on ClinicalTrials.gov
What's tested:BIS groupNon-BIS group

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Median ventilator time reported in hours
Measured over 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)
Sedation
1 sites across 1 states
Texas1
  • Pascal L Kingah, MD, MPH · PRINCIPAL_INVESTIGATOR · The University of Texas Health Science Center, Houston

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Eligibility criteria

Inclusion

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

Exclusion

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
  • Median ventilator time reported in hoursfrom 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)