Heartbeat clues could forecast ventilator freedom
NCT ID NCT07771101
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
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About 50 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2026
- Expected to finish
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Aug 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Seoul Metropolitan Government Seoul National University Boramae Medical Center
RECRUITINGSeoul, 07061, South Korea
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Other studies related to the condition(s) this trial covers.
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- Could a simple valve make manual ventilation safer during surgery?
- Can exercise help Ventilator-Dependent seniors breathe easier?
- Ultrasound may reveal hidden causes of ventilator weaning failure
- Computer coach may cut time on breathing machines
- Study to reveal best way to ventilate patients on the move