Actively Recruiting
Multidimensional Correlation Analysis of Heart Rate Variability and Weaning Assessment Parameters in Critically Mechanically Ventilated Patients
Led by Fu Jen Catholic University Hospital · Updated on 2026-04-09
100
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying patients who need help breathing with mechanical ventilators to improve the timing of safely removing this support. The study focuses on combining heart rate variability (HRV) measurements with traditional assessments for weaning patients off ventilators. Previous studies showed HRV differs between successful and failed extubation but were limited by small samples and single HRV indicators, so this study aims to develop a more objective and sensitive model using multiple HRV parameters alongside standard measures. Participants will be observed using the BEATINFO ECG Sensor device to analyze changes in HRV during key phases: the Spontaneous Breathing Trial (SBT), extubation, and after extubation. This observational study captures various HRV time and frequency domain parameters to evaluate how well they predict successful weaning from invasive mechanical ventilation. During the study, patients will be monitored for at least 72 hours after extubation to collect follow-up data. Researchers will assess ventilator-free days within 3 days as the primary outcome. Stable ECG signals are required for HRV analysis, and consent is obtained from patients or their legal representatives. The total participation duration includes monitoring before, during, and after ventilator removal to gather comprehensive physiological and clinical data for the predictive model.
CONDITIONS
Brief Title
Multidimensional Correlation Analysis of Heart Rate Variability and Weaning Assessment Parameters in Critically Mechanically Ventilated Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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, suitable for heart rate variability analysis
- Provided informed consent to participate and cooperate with 72-hour follow-up after extubation
You will not qualify if you...
- Having a permanent pacemaker, defibrillator, or other devices affecting monitoring data
- On continuous deep sedation (Richmond Agitation-Sedation Scale C= -4) and unable to regain consciousness soon
- Severe arrhythmias or unstable cardiovascular conditions preventing reliable heart rate variability analysis
- Cognitive impairment, mental illness, or clinical judgment deeming participation unsuitable
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 3 days
Participants undergo monitoring using the BEATINFO ECG Sensor during spontaneous breathing trial, extubation, and post-extubation periods to analyze heart rate variability and weaning parameters.
Continuous monitoring during this period
Duration - 72 hours after extubation
Participants are followed for 72 hours after extubation for further assessment and data collection.
Follow-up assessments during this period
Trial Site Locations
Total: 1 location
1
Fu Jen Catholic University Hospital
New Taipei City, Taiwan
Actively Recruiting
Research Team
C
Chi-Wei Tseng
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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