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

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.

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Key information

Conditions

Weaning Invasive Mechanical Ventilation

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Fu Jen Catholic University Hospital

New Taipei City, Taiwan

Location status: Recruiting

Location contact

Chi-Wei Tseng

CONTACT

[email protected]

+886905301759

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BEATINFO ECG Sensor

Device

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.

Primary outcomes

ventilator-free days(VFDs)

Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Chi-Wei Tseng

CONTACT

[email protected]

+886960-756-606 ext. 28754

Sponsors and collaborators

Lead sponsor

Fu Jen Catholic University Hospital

Other

Registry information

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2026
First posted: Mar 6, 2026
Registry last updated: Apr 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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