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

April 6, 2026 updated by: Fu Jen Catholic University Hospital

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
      • New Taipei City, Taiwan
        • Recruiting
        • Fu Jen Catholic University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

This study will recruit participants from the Intensive Care Unit (ICU) of Fu Jen Catholic University Hospital, including the Medical Intensive Care Unit, Surgical Intensive Care Unit, and Respiratory Care Center.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
up to 3 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fu Jen Catholic University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 9, 2025

Primary Completion (Estimated)

August 31, 2026

Study Completion (Estimated)

August 31, 2026

Study Registration Dates

First Submitted

March 2, 2026

First Submitted That Met QC Criteria

March 3, 2026

First Posted (Actual)

March 6, 2026

Study Record Updates

Last Update Posted (Actual)

April 9, 2026

Last Update Submitted That Met QC Criteria

April 6, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • FJUH114476

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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