Clinical trial Recruiting at 1 site Observational Ages 18 and up

Can a chest heart rhythm monitor help predict when ICU patients on a ventilator can breathe without the tube?

Official title: Association Between Early Autonomic Dysfunction Measured by the Analgesia Nociception Index (ANI) and Prolonged Mechanical Ventilation in Postoperative ICU Patients

Run by Seoul National University Hospital · NCT07771101 · Data updated 2026-11-12

This study tests if a chest monitor that tracks heart rhythm can help predict when adults in the ICU on a ventilator will be able to breathe on their own after extubation.

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment50 (estimated)
SponsorSeoul National University Hospital
Academic / other
Locations1 site (Seoul)
StatusRecruiting
StartedAugust 11, 2026
Main results expectedFebruary 12, 2027
Study endsAugust 12, 2027
Registry record updatedAugust 18, 2026
Trial IDNCT07771101 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults (18+) recovering from surgery in the surgical ICU who are on mechanical ventilation and receiving dexmedetomidine as their main sedative.

Probably not a fit

Patients with certain arrhythmias, those with a tracheostomy, or with life-sustaining treatment decisions in place may not benefit from this approach.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational pilot study follows adults who recently had surgery and are in the surgical ICU while they are on mechanical ventilation. Researchers will place chest patches to record heart rhythm for five minutes at four time points: after ICU admission, before a spontaneous breathing trial, during the trial, and right after the tube is removed. The goal is to see if heart rate variability patterns, reflecting autonomic function, can indicate likelihood of successful extubation and how these patterns change during weaning. Data will be collected as part of standard ICU care with readings kept separate from clinical decision-making. The study aims to identify potential bedside markers that could help time weaning to reduce complications.

Why it matters

Potential benefit: If successful, this approach could help clinicians predict extubation readiness and reduce time on the ventilator and related complications.

How similar studies have gone: Prior work has linked autonomic markers to weaning outcomes, but bedside-ready, real-time use has been limited; this pilot tests a practical monitoring approach.

Who can join: the full rules

Show full inclusion / exclusion criteria
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

Where it's running

  • Seoul Metropolitan Government Seoul National University Boramae Medical Center
    Seoul, South Korea
    Recruiting

Study contacts

  • Principal investigator: Saeyeon Kim, M.D., Ph.D. — SMG-SNU Boramae Medical Center
  • Study coordinator: Sangbae Park, M.S.N.
  • Email: parkbreeze@gmail.com
  • Phone: 82-1577-0075

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.