Heart rate variability and standard tests to help decide when to remove a breathing tube

Multidimensional Correlation Analysis of Heart Rate Variability and Weaning Assessment Parameters in Critically Mechanically Ventilated Patients

This study will test whether combining heart rate variability from a wearable ECG sensor with standard weaning tests can help doctors decide when patients on mechanical ventilation are ready to have the breathing tube removed.

Quick facts

• Study type: Observational
• Enrollment: 100 (estimated)
• Ages: 18 Years to 85 Years
• Sex: All
• Sponsor: Fu Jen Catholic University Hospital (other)
• Locations: 1 site (New Taipei City)
• Trial ID: NCT07455214 on ClinicalTrials.gov

What this trial studies

This observational study enrolls adult ICU patients who have been mechanically ventilated for more than 24 hours and are judged ready for a spontaneous breathing trial. Continuous ECG data will be collected with the BEATINFO sensor to calculate multiple HRV measures, which will be integrated with traditional weaning parameters to develop a predictive model. Patients with pacemakers, severe arrhythmias, continuous deep sedation, or unstable cardiovascular status are excluded because HRV would be unreliable. Extubation outcomes will be followed for 72 hours to classify success or failure and test the model's predictive performance.

Who should consider this trial

Good fit: Adults 18–85 who have been mechanically ventilated for more than 24 hours, are clinically ready for a spontaneous breathing trial, have stable ECG signal quality for HRV analysis, and can provide informed consent (or have a legal representative) are ideal candidates.

Not a fit: Patients with permanent pacemakers or defibrillators, continuous deep sedation, severe arrhythmias or unstable cardiovascular conditions, significant cognitive impairment, or insufficient ECG signal quality are unlikely to benefit from the HRV-based approach.

Why it matters

Potential benefit: If successful, the combined HRV and traditional-parameter model could give clinicians a more objective, sensitive way to time extubation and reduce failed extubations and related complications.

How similar studies have performed: Prior small studies have reported differences in HRV between successful and failed extubations, but most used single HRV metrics in small cohorts, so combining multidimensional HRV with standard measures is relatively untested.

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.

Where this trial is running

New Taipei City

• Fu Jen Catholic University Hospital — New Taipei City, Taiwan (RECRUITING)

Study contacts

• Study coordinator: Chi-Wei Tseng

Conditions: Weaning Invasive Mechanical Ventilation, Heart rate variability, BEATINFO ECG Sensor, Weaning assessment parameters