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).
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
OBSERVATIONAL
Enrollment
150
Respiratory drive assessed by flow index measured by electrical impedance tomography.
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Fujian Provincial Hospital
Fuzhou, Fujian, China
Department of Critical Care Medicine,Ruijin Hospital,Shanghai Jiao Tong University School of Medicine,Shanghai,China.
Shanghai, China
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.
Time frame: Within 30 minutes of Spontaneous Breathing Trial (SBT)
Reintubation Rate within 48 hours
Proportion of patients requiring reintubation within 48 hours following successful extubation.
Time frame: Within 48 hours after extubation.
Ventilator-Free Days by Day 7
Number of days free from mechanical ventilation within 7 days after extubation.
Time frame: Within 7 days after extubation.
ICU Mortality
Mortality rate of patients during their ICU stay in this study.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: During ICU stay or within 24 hours after ICU discharge
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