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Brain wave monitor may help ventilator patients wake up faster

NCT ID NCT07219069

Symptom relief Sponsor: The University of Texas Health Science Center, Houston Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether using a Bispectral index (BIS) monitor, which tracks brain activity, can help doctors better manage sedation in patients on breathing machines. Researchers will compare how long patients stay on the ventilator, their ICU stay, and the amount of sedation drugs used between those monitored with BIS and those without. The trial aims to enroll 30 adults in the medical ICU who are on sedation infusions.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Bispectral index (BIS) monitoring device
What this could lead to
If it works, this could help doctors adjust sedation more precisely, potentially reducing time on a ventilator and sedation use in the ICU.
What could go wrong
This is a small, early-stage trial with only 30 participants, so results may not apply broadly. The device is a monitoring tool, not a treatment, so benefits may be modest.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2025

Expected to finish

Nov 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Sedation

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Memorial Hermann Cypress Hospital

    RECRUITING

    Cypress, Texas, 77433, United States

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