Electrical Impedance Tomography-Derived Flow Index for Predicting Weaning Success and Post-Extubation Outcomes: A Multicenter Prospective Observational Study (EIT-FI Weaning)

Shanghai Jiao Tong University

Status

Completed

Conditions

Acute Respiratory Failure

Respiratory Drive

Treatments

Device: electrical impedance tomography

Study type

Observational

Funder types

Other

Identifiers

NCT06876792

202530

Details and patient eligibility

About

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) investigate the association between FI and pendelluft magnitude as a potential marker of patient self-inflicted lung injury (P-SILI).

Full description

This multicenter observational study was conducted in three ICUs in China. Adult patients (≥18 years) who received invasive mechanical ventilation for

≥48 hours and met standard criteria for SBT readiness underwent a standardized 30-minute pressure-support SBT (PSV 8 cmH₂O, PEEP 5 cmH₂O, FiO₂ ≤0.5). Continuous EIT recordings were performed to calculate global and regional FI from pixel-level inspiratory flow-time curves. Pendelluft magnitude was quantified as the percentage of intrapulmonary gas redistribution during inspiration. Conventional indices (RSBI, MIP, P0.1, NIF) and physiological variables were recorded. Primary Endpoint: SBT success (completion without respiratory distress, desaturation, or hemodynamic instability).

Secondary Endpoints:

Reintubation within 48 h
Weaning failure
Ventilator-free days at day 7
ICU mortality Predictive accuracy was evaluated via ROC analysis in training (n=90) and validation (n=60) cohorts.

Enrollment

150 patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

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