Acute Respiratory FailureEIT-FI WeaningNCT06876792
Electrical Impedance Tomography-derived Flow Index During Spontaneous Breathing Trial Stratifies the Risk of Reintubation Within 48 h After Extubation
An observational study of Acute Respiratory Failure and Ventilator Weaning Assessment, run by Ruijin Hospital at 3 sites in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Acute Respiratory Failure, Ventilator Weaning Assessment
- What is being tested?
- electrical impedance tomography
- Type of treatment
- Medical device
- How many people
- 150 participants
- Where
- 3 sitesChina
- Study dates
- 1 Dec 2024to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
China3 sites
Peking Union Medical College Hospital
Beijing, Beijing Municipality
Fujian Provincial Hospital
Fuzhou, Fujian, 200025
Department of Critical Care Medicine，Ruijin Hospital，Shanghai Jiao Tong University School of Medicine，Shanghai，China.
Shanghai, 200025
About this study
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).
Read the 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.
- Being tested
- electrical impedance tomography
- Keywords
- acute respiratory failure, Respiratory drive, Electrical Impedance Tomography (EIT)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electrical impedance tomographyDevice
Respiratory drive assessed by flow index measured by electrical impedance tomography.
| Study group | Role | What they receive |
|---|---|---|
| Conventional method Respiratory Drive group | Conventional method Respiratory Drive group（Methods include: esophageal pressure monitoring, airway obstruction pressure (P0.1) ) Receives: Device: electrical impedance tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spontaneous Breathing Trial (SBT) Success Rate
Proportion of patients who complete the 30-minute Spontaneous Breathing Trial (SBT) without signs of respiratory distress, hypoxemia, or hemodynamic instability.
Measured: Within 30 minutes of Spontaneous Breathing Trial (SBT)
Secondary outcomes (6)
Reintubation Rate within 48 hours
Proportion of patients requiring reintubation within 48 hours following successful extubation.
Measured: Within 48 hours after extubation.
Ventilator-Free Days by Day 7
Number of days free from mechanical ventilation within 7 days after extubation.
Measured: Within 7 days after extubation.
ICU Mortality
Mortality rate of patients during their ICU stay in this study.
Measured: during the ICU stay or within 24 hours following transfer out of the ICU
Reintubation rate within 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.
Measured: within the 48 hours after extubation
Ventilator-Free Days at Day 7 (VFD-7)
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.
Measured: Within 7 days after extubation
ICU Mortality
Proportion of patients who died during ICU hospitalization or within 24 hours after transfer out of the ICU.
Measured: During ICU stay or within 24 hours after ICU discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2025
- Study start1 Dec 2024
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Respiratory FailureStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Fujian Provincial Hospital, Peking Union Medical College Hospital
- Responsible party
- Sponsor
- Investigators
- Hongping Qu, Study chair, Department of Critical Care Medicine，Ruijin Hospital，Shanghai Jiao Tong University School of MedicineJialin Liu, Study director, Department of Critical Care Medicine，Ruijin Hospital，Shanghai Jiao Tong University School of Medicinerui zhang, Principal investigator, Department of Critical Care Medicine，Ruijin Hospital，Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06876792
- Sponsor's protocol ID
- 202530
- Acronym
- EIT-FI Weaning
- Status last verified
- Dec 2025
- First submitted
- 10 Mar 2025
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The raw data supporting the conclusions of this article will be made available by the authors, without undue reservation
Publications
Zhang R, Xu J, Wu J, Tan R, He H, Long Y, Hong D, Wu D, Qu H, Zhao Z, Liu J. Electrical impedance tomography-derived flow index during spontaneous breathing trial stratifies the risk of reintubation within 48 h after extubation. Crit Care. 2026 May 31;30(1):401. doi: 10.1186/s13054-026-06098-3.
PubMed 42219497
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electrical Impedance Tomography-derived Flow Index During Spontaneous Breathing Trial Stratifies the Risk of Reintubation Within 48 h After Extubation
- ClinicalTrials.gov ID
- NCT06876792
- Acronym / sponsor ID
- EIT-FI Weaning / 202530
- Keywords
- acute respiratory failure, Respiratory drive, Electrical Impedance Tomography (EIT)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Collaborators
- Fujian Provincial Hospital, Peking Union Medical College Hospital
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 14 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Conventional method Respiratory Drive group | – | Device: electrical impedance tomographyConventional method Respiratory Drive group（Methods include: esophageal pressure monitoring, airway obstruction pressure (P0.1) ) |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- Neuromuscular diseases impairing spontaneous breathing
- High cervical spinal cord injury
- Deep sedation (RASS ≤-3)
- Inadequate EIT signal quality
- Contraindications to EIT
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| electrical impedance tomographyRespiratory drive assessed by flow index measured by electrical impedance tomography. | Device | Conventional method Respiratory Drive group |
Primary outcome
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.
6 secondary outcomes
Reintubation Rate within 48 hours
Time frame: Within 48 hours after extubation.
Ventilator-Free Days by Day 7
Time frame: Within 7 days after extubation.
ICU Mortality
Time frame: 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
Ventilator-Free Days at Day 7 (VFD-7)
Time frame: Within 7 days after extubation
ICU Mortality
Time frame: During ICU stay or within 24 hours after ICU discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
- Derived from this study: PubMed 42219497Zhang R, Xu J, Wu J, Tan R, He H, Long Y, Hong D, Wu D, Qu H, Zhao Z, Liu J. Electrical impedance tomography-derived flow index during spontaneous breathing trial stratifies the risk of reintubation within 48 h after extubation. Crit Care. 2026 May 31;30(1):401. doi: 10.1186/s13054-026-06098-3.
- Individual participant dataSharing planned: No. The raw data supporting the conclusions of this article will be made available by the authors, without undue reservation
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hongping Qu study chair
Department of Critical Care Medicine，Ruijin Hospital，Shanghai Jiao Tong University School of Medicine
Jialin Liu study director
Department of Critical Care Medicine，Ruijin Hospital，Shanghai Jiao Tong University School of Medicine
rui zhang principal investigator
Department of Critical Care Medicine，Ruijin Hospital，Shanghai Jiao Tong University School of Medicine
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Respiratory Failure and Ventilator Weaning Assessment, run by Ruijin Hospital at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spontaneous Breathing Trial (SBT) Success Rate (time frame: Within 30 minutes of Spontaneous Breathing Trial (SBT)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06876792, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2026.