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NCT Number: NCT06876792

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

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).

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Peking Union Medical College Hospital, Beijing, Beijing Municipality, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

electrical impedance tomography

Device

Respiratory drive assessed by flow index measured by electrical impedance tomography.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Reintubation Rate within 48 hours

    Time frame: Within 48 hours after extubation.

    Proportion of patients requiring reintubation within 48 hours following successful extubation.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Sponsors and collaborators

Lead sponsor

Ruijin Hospital

Other

Collaborators

  • Fujian Provincial Hospital
  • Peking Union Medical College Hospital

Registry information

Acronym: EIT-FI Weaning

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 14, 2025
Registry last updated
Apr 23, 2026

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

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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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