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Recruiting Observational

Can a Pain Monitor Predict When Postoperative Intensive Care Unit Patients Are Ready to Breathe on Their Own? A Pilot Study

NCT07771101 · tracked via the Priya Life Science South Korea tracker
Phase
Observational
Started
2026-08-11
Last updated
2026-08-18

Condition(s) studied

Ventilator WeaningAirway ExtubationRespiration, Artificial

Study summary

The goal of this observational study is to learn if a chest monitor that tracks heart rhythm can help predict whether adults on a breathing machine after surgery will be able to breathe on their own once the breathing tube is removed. It is being done in adults recovering from surgery in the intensive care unit (ICU).

The main questions it aims to answer are:

Can heart rhythm patterns, measured soon after ICU admission and during a breathing test, show whether a patient is likely to breathe well without the machine? Do these patterns change in a helpful way when the breathing tube is removed?

Participants will:

Have soft, sticky patches placed on their chest, similar to those used for a regular heart monitor Have their heart rhythm recorded for 5 minutes at four times: soon after ICU admission, before a breathing test, during the breathing test, and right after the breathing tube is removed Continue to receive their usual ICU care; doctors will not see the monitor's readings, so these readings will not affect any treatment decisions

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • proportion of participants with successful extubation — Within 48 hours after extubation
    A participant's breathing tube is removed (extubated) after a period of mechanical ventilation, following a trial in which the ventilator support is reduced to see if the participant can breathe adequately on their own (a spontaneous breathing trial). Extubation is considered successful if the participant does not need the breathing tube reinserted within 48 hours. If a participant dies within this 48-hour window without having the breathing tube reinserted, this is not counted as a failed extubation and is recorded as a separate outcome. This outcome will be analyzed in relation to heart rate variability measurements (an indicator of autonomic nervous system activity, obtained non-invasively from a chest monitor) taken at the time of intensive care unit admission, before the breathing trial, and during the breathing trial.

Trial sites (1)

FacilityCityRegionStatus
Seoul Metropolitan Government Seoul National University Boramae Medical Center Seoul South Korea Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07771101 on ClinicalTrials.gov ↗ ← All trials in South Korea