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Brain monitor reveals hidden risks of sedation after heart surgery

NCT ID NCT07350109

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study observed 50 heart surgery patients in the ICU to see how often they were deeply sedated using a brain activity monitor (BIS). The monitor readings were hidden from doctors, so they didn't affect care. The goal was to understand if deep sedation affects recovery time, infections, or confusion. Results may help improve sedation practices in the future.

What this could mean

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

What this could lead to
If successful, this could lead to better sedation guidelines for ICU patients after heart surgery, potentially reducing complications like delirium or infections.
What could go wrong
This is a small observational study with only 50 patients, so results may not apply to all hospitals or patients. It does not test a new treatment, so direct benefits are limited.

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.

Participants

50 people

The number who actually took part.

Started

Nov 2025

Finished

Mar 2026

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.

Who is studied

patients admitted to the ICU following cardiac surgery. These patients are expected to require invasive mechanical ventilation and continuous sedation for more than 6 hours postoperatively.

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: * Age ≥ 18 years. * Undergoing cardiac surgery with subsequent admission to the ICU * expected duration of invasive mechanical ventilation \> 6 hours postop. * Written informed consent obtained from the patient or legal representative (if the patient is not capable of consent). Exclusion Criteria: * Pre-existing neurological disorders affecting consciousness or sedation assessment (e.g., severe dementia, epileptic encephalopathy). * Acute neurological events in the perioperative period (e.g., stroke, intracranial hemorrhage). * Severe hepatic dysfunction (Child-Pugh Class C). * Participation in another interventional study potentially affecting sedation or cognitive outcomes. * Pregnancy or lactation. * Patients in whom short-term survival is deemed unlikely due to clinical course

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As listed by the trial registrant

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

Contacts and locations

Locations

  • Klinikum Wels

    Wels, Upper Austria, 4600, Austria

  • Medical University Graz

    Graz, Styria, 8010, Austria