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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-09-01

Study Completion Date

2024-05-31

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Respiratory Drive Acute Respiratory Failure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Conventional method Respiratory Drive group

Conventional method Respiratory Drive group（Methods include: esophageal pressure monitoring, airway obstruction pressure (P0.1) )

electrical impedance tomography

Intervention Type DEVICE

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

Interventions

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electrical impedance tomography

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

Intervention Type DEVICE

Eligibility Criteria

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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 (e.g., implanted cardiac devices)
* Pregnancy
* Expected survival \<24 h

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No