NCT07455214 Multidimensional Correlation Analysis of Heart Rate Variability and Weaning Assessment Parameters in Critically Mechanically Ventilated Patients
| NCT ID | NCT07455214 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fu Jen Catholic University Hospital |
| Condition | Weaning Invasive Mechanical Ventilation |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2025-12-09 |
| Primary Completion | 2026-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2025-12-09 with a primary completion date of 2026-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07455214 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 85 Years, studying Weaning Invasive Mechanical Ventilation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07455214 currently recruiting?
Yes, NCT07455214 is actively recruiting participants. Contact the research team at kiwitseng724@gmail.com for enrollment information.
Where is the NCT07455214 trial being conducted?
This trial is being conducted at New Taipei City, Taiwan.
Who is sponsoring the NCT07455214 clinical trial?
NCT07455214 is sponsored by Fu Jen Catholic University Hospital. The trial plans to enroll 100 participants.