Bispectral monitoring to guide sedation in mechanically ventilated ICU patients
Official title: Bispectral Monitoring on Mechanically Ventilated Patients, a Randomized Clinical Trial. (BIMV Trial)
Run by The University of Texas Health Science Center, Houston · NCT07219069 · Data updated 2026-11-12
This study tests whether using BIS monitoring while patients are sedated on ventilators changes how long they stay on ventilation, ICU stay, and the total amount of sedation given.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | The University of Texas Health Science Center, Houston Academic / other |
| Locations | 1 site (Cypress, Texas) |
| Status | Recruiting |
| Started | November 1, 2025 |
| Main results expected | November 1, 2026 |
| Study ends | November 1, 2026 |
| Registry record updated | June 25, 2026 |
| Trial ID | NCT07219069 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults in the medical ICU who require mechanical ventilation and are on sedation infusions.
✕Probably not a fit
Patients with certain conditions or exclusions (e.g., chronic opioid use, end-stage liver disease, pregnancy, skin issues with BIS sensors, or those on neuromuscular blockade) may not benefit from BIS monitoring.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional study compares two groups of adults in an medical ICU who require mechanical ventilation and sedation. One group uses Bispectral Index (BIS) monitoring to guide sedation; the control group does not use BIS. The trial aims to see if BIS guidance reduces duration of ventilation, shortens ICU length of stay, and lowers overall sedation dose. Participants are adults admitted to the medical ICU who are intubated and on sedation infusions, with several exclusion criteria such as chronic opioid use, end-stage liver disease, pregnancy, and inability to complete follow-up. The lead sponsor is The University of Texas Health Science Center, Houston, with the Memorial Hermann Cypress Hospital as the site.
Why it matters
Potential benefit: If BIS-guided sedation proves beneficial, patients could experience shorter ventilation times and ICU stays, with potentially lower sedation exposure.
How similar studies have gone: Previous studies on BIS-assisted sedation have shown mixed results; this trial addresses this question specifically in mechanically ventilated ICU patients.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Memorial Hermann Cypress Hospital
Cypress, Texas, United States Recruiting
Study contacts
- Principal investigator: Pascal L Kingah, MD, MPH — The University of Texas Health Science Center, Houston
- Study coordinator: Pascal L Kingah, MD, MPH
- Email: Pascal.L.Kingah@uth.tmc.edu
- Phone: 713 500 6828
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Perioperative risks in adults with Brugada syndrome during anesthesia and related procedures
This registry follows adults with Brugada syndrome to see how often dangerous heart rhythms occur around anesthesia and up to 30 days after.
-
Neonatal Neurological Observation With Video AI
This study tests a real-time, non-contact video AI system to help monitor brain health in newborns with suspected brain injury during their hospital stay.
-
Remimazolam sedation in ICU patients on mechanical ventilation
This study tests whether using remimazolam for sedation helps mechanically ventilated ICU patients recover better compared to another sedative.
-
Sedation with dexmedetomidine, propofol, or both during cataract surgery
This project will test whether dexmedetomidine, propofol, or their combination (each given with fentanyl) provides the best sedation, safety, and surgeon satisfaction for adults having cataract surgery.
-
Light exposure during general anesthesia
This test checks whether covering patients' eyes during general anesthesia changes how much anesthetic adults (18–65) need.
-
Comparing two propofol dosing models for sedated ICU patients on ventilators
This study will test whether the Eleveld or Schnider dosing model gives steadier propofol sedation for adults on mechanical ventilation in the ICU.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.