BEATINFO ECG Sensor: This study will analyze changes in HRV time and frequency domain parameters during SBT, extubation, and post-extubation to evaluate their predictive value for weaning outcomes.
Study summary
Background： Conventional weaning assessments are widely used but often affected by factors such as poor patient cooperation, neuromuscular issues, or unstable consciousness, leading to uncertainty in extubation timing. Studies have shown that HRV differs significantly between successful and failed extubation cases. However, most research features small sample sizes, focuses on single HRV indicators, and lacks integration with traditional assessments, limiting HRV's clinical application.
Effect： The study aims to develop a predictive model combining HRV and traditional weaning indicators to provide a more objective and sensitive physiological reference for ventilator weaning decisions in critical care settings.
Eligibility
Sex
ALL
Min age
18 Years
Max age
85 Years
Healthy volunteers
No
Inclusion Criteria:
* Age between 18 and 85 years.
* Received mechanical ventilation for more than 24 hours and clinically assessed as ready for a Spontaneous Breathing Trial (SBT).
* Stable ECG signal quality before extubation, meeting the basic requirements for HRV analysis.
* Obtained informed consent from the patient or their legal representative, and agreed to participate in this study and cooperate with the 72-hour follow-up after extubation.
Exclusion Criteria:
* Individuals with permanent pacemakers, defibrillators, or other devices that affect monitoring data.
* Individuals on continuous deep sedation (RAS ≤ -4) and unable to regain consciousness in the short term.
* Individuals with severe arrhythmias or unstable cardiovascular conditions that prevent reliable HRV analysis.
* Individuals with cognitive impairment or mental illness that prevents them from cooperating with the research process, or individuals deemed unsuitable for participation in this study by their clinicians.
Primary outcome measure(s)
ventilator-free days(VFDs) — up to 3 days Perform the extubation procedure based on clinical judgment, and record the extubation process and its success or failure in detail (successful extubation is defined as not requiring reintubation within 24 hours after extubation; and the condition should be continuously monitored for up to 72 hours after extubation). Simultaneously record the clinical outcomes after extubation, including the occurrence of VAP, ICU stay days, total hospital stay, and reintubation rate.
Trial sites (1)
Facility
City
Region
Status
Fu Jen Catholic University Hospital
New Taipei City
Taiwan
Recruiting
More Fu Jen Catholic University Hospital trials in Taiwan
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.
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