Multidimensional Correlation Analysis of Heart Rate Variability and Weaning Assessment Parameters… (NCT07455214) | Clinical Trial Compass
RecruitingNot Applicable
Multidimensional Correlation Analysis of Heart Rate Variability and Weaning Assessment Parameters in Critically Mechanically Ventilated Patients
Taiwan100 participantsStarted 2025-12-09
Plain-language 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.
Who can participate
Age range
18 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.