Heartbeat clues could forecast ventilator freedom

NCT ID NCT07771101

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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 Results may not be published yet.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.
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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

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Status unknown
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First seen Aug 18, 2026 · Last updated Aug 19, 2026 · Updated 1 time

Summary

This study explores whether a simple chest monitor that tracks heart rhythm can help predict if adults in the intensive care unit (ICU) after surgery will breathe well on their own once their breathing tube is removed. Researchers will record heart rhythm patterns for 5 minutes at several key moments, including soon after ICU admission and during a breathing test. The goal is to see if these patterns indicate how ready a patient's body is to breathe without the ventilator. The monitor's readings will not influence treatment decisions, as this is purely an observational study.

What this could mean

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

Active substance
Analgesia Nociception Index (ANI) monitoring - a non-invasive chest monitor that tracks heart rhythm patterns
What this could lead to
If successful, this could give doctors a simple, non-invasive tool to better predict which ICU patients are ready to breathe without a ventilator, potentially reducing complications and speeding recovery.
What could go wrong
This is a small observational study, so it cannot prove cause and effect. The heart rhythm patterns may not reliably predict breathing success in all patients, and the results may not apply beyond the specific ICU setting.

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

About 50 people

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

Started

Aug 2026

Expected to finish

Aug 2027

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.

Who is studied

Participants are drawn from adult patients admitted to the surgical intensive care unit (ICU) of Seoul Metropolitan Government Seoul National University Boramae Medical Center, a public academic hospital in Seoul, South Korea, following surgery. The surgical ICU cares for postoperative patients across multiple surgical specialties, including general surgery, thoracic and cardiovascular surgery, and other surgical disciplines requiring postoperative critical care. Eligible participants are identified from among those requiring invasive mechanical ventilation after surgery and sedated according to standard ICU sedation practice at this institution.

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 or older * Admitted to the surgical intensive care unit (ICU) after surgery * Currently on a breathing machine (mechanical ventilation) through a tube in the airway * Receiving dexmedetomidine as the main sedative medication, with a stable, predefined level of sedation * Participant or their legal representative agrees to take part in the study Exclusion Criteria: * Permanent irregular heart rhythm (atrial fibrillation or atrial flutter) * Complete heart block or a heart rhythm that is fully controlled by a pacemaker * Already has a tracheostomy (a breathing tube placed through the neck) * A decision has already been made at ICU admission to withhold or withdraw life-sustaining treatment * Deeply sedated without receiving any sedative medication, suggesting the low alertness may be due to a brain-related problem rather than medication

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Conditions

The condition(s) this trial relates to.

Critical Illness Respiratory Aspiration

As listed by the trial registrant

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

How to take part

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  1. The places running it

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  2. The official record

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  3. A doctor treating you

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Contacts and locations

Locations

  • Seoul Metropolitan Government Seoul National University Boramae Medical Center

    RECRUITING

    Seoul, 07061, South Korea

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