Electrical Impedance Tomography-derived Flow Index During Spontaneous Breathing Trial Stratifies the Risk of Reintubation Within 48 h After Extubation (EIT-FI Weaning)

April 20, 2026 updated by: Ruijin Hospital
Accurate prediction of readiness to liberate patients from mechanical ventilation remains challenging. Conventional indices such as the rapid shallow breathing index (RSBI) and maximal inspiratory pressure (MIP) often miss early signs of injurious breathing patterns or regional ventilation asynchrony that can lead to extubation failure. Electrical impedance tomography (EIT) provides continuous, non-invasive imaging of regional lung ventilation. We developed a novel EIT-derived Flow Index (FI) which integrates the magnitude of inspiratory effort with the temporal synchrony of lung filling. This prospective, multicenter observational study aimed to (1) validate the predictive value of FI during spontaneous breathing trials (SBT) compared with conventional weaning indices, and (2) compare the predictive ability of EFI with traditional weaning indices(RSBI,MIP,P0.1).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This multicenter observational study was conducted in three tertiary ICUs in China. Adult patients (≥18 years) receiving invasive mechanical ventilation for ≥48 hours and meeting readiness criteria underwent a standardized 30-minute pressure support SBT (PS 8 cmH₂O, PEEP 5 cmH₂O, FiO₂ ≤0.5) with continuous EIT monitoring. EFI was calculated breath by breath from the global impedance-time signal. Conventional weaning indices (RSBI, MIP, P0.1) and physiological variables were recorded.

Primary endpoint: SBT success (completion of 30-minute SBT without predefined failure criteria).

Key secondary endpoint: reintubation within 48 hours after extubation. Other secondary endpoints: ventilator-free days at day 7 (VFD-7), ICU mortality. Predictive performance was assessed using ROC analysis. The EFI cutoff value was derived from the primary endpoint analysis and carried forward for post-extubation risk stratification.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
150

Contacts and Locations

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

Study Locations

  • China
      • Shanghai, China, 200025
        • Department of Critical Care Medicine，Ruijin Hospital，Shanghai Jiao Tong University School of Medicine，Shanghai，China.
    • Beijing Municipality
      • Beijing, Beijing Municipality, China
        • Peking Union Medical College Hospital
    • Fujian
      • Fuzhou, Fujian, China, 200025
        • Fujian Provincial Hospital

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

  1. 150 critically ill patients requiring respiratory support were planned for inclusion
  2. Age ≥18 years
  3. Gender is not limited
  4. Patients with expected duration of respiratory support >24 hours

Description

Inclusion Criteria:

  • Age ≥18 years
  • Acute respiratory failure requiring intubation and mechanical ventilation ≥48 hours
  • Hemodynamic stability (no escalation of vasoactive agents)
  • Oxygenation: FiO₂ ≤0.5, PEEP ≤8 cmH₂O
  • Meeting standard ICU criteria for SBT readiness

Exclusion Criteria:

  • Neuromuscular diseases impairing spontaneous breathing
  • High cervical spinal cord injury
  • Deep sedation (RASS ≤-3)
  • Inadequate EIT signal quality
  • Contraindications to EIT
  • Pregnancy
  • Expected survival <24 h

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Conventional method Respiratory Drive group
Conventional method Respiratory Drive group（Methods include: esophageal pressure monitoring, airway obstruction pressure (P0.1) )
Device: electrical impedance tomography
Respiratory drive assessed by flow index measured by electrical impedance tomography.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Spontaneous Breathing Trial (SBT) Success Rate
Time Frame: Within 30 minutes of Spontaneous Breathing Trial (SBT)
Proportion of patients who complete the 30-minute Spontaneous Breathing Trial (SBT) without signs of respiratory distress, hypoxemia, or hemodynamic instability.
Within 30 minutes of Spontaneous Breathing Trial (SBT)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Reintubation Rate within 48 hours
Time Frame: Within 48 hours after extubation.
Proportion of patients requiring reintubation within 48 hours following successful extubation.
Within 48 hours after extubation.
Ventilator-Free Days by Day 7
Time Frame: Within 7 days after extubation.
Number of days free from mechanical ventilation within 7 days after extubation.
Within 7 days after extubation.
ICU Mortality
Time Frame: during the ICU stay or within 24 hours following transfer out of the ICU
Mortality rate of patients during their ICU stay in this study.
during the ICU stay or within 24 hours following transfer out of the ICU
Reintubation rate within 48 hours after extubation
Time Frame: within the 48 hours after extubation
Proportion of patients who successfully completed the spontaneous breathing trial (SBT) and underwent planned extubation who required reintubation within 48 hours after extubation.
within the 48 hours after extubation
Ventilator-Free Days at Day 7 (VFD-7)
Time Frame: Within 7 days after extubation
Number of days alive and free from invasive mechanical ventilation within 7 days after extubation. Days after reintubation are not counted as ventilator-free days.
Within 7 days after extubation
ICU Mortality
Time Frame: During ICU stay or within 24 hours after ICU discharge
Proportion of patients who died during ICU hospitalization or within 24 hours after transfer out of the ICU.
During ICU stay or within 24 hours after ICU discharge

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ruijin Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Peking Union Medical College Hospital
Fujian Provincial Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Hongping Qu, Department of Critical Care Medicine，Ruijin Hospital，Shanghai Jiao Tong University School of Medicine
  • Study Director: Jialin Liu, Department of Critical Care Medicine，Ruijin Hospital，Shanghai Jiao Tong University School of Medicine
  • Principal Investigator: rui zhang, Department of Critical Care Medicine，Ruijin Hospital，Shanghai Jiao Tong University School of Medicine

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 10, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 10, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 14, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 23, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 20, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 202530

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The raw data supporting the conclusions of this article will be made available by the authors, without undue reservation

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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