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

NCT06876792 | Completed DMC

• 1 other identifier: 202530
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 3

Brief 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 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).

Conditions

Acute Respiratory Failure; Ventilator Weaning Assessment

Keywords

acute respiratory failure; Respiratory drive; Electrical Impedance Tomography (EIT)

Outcome Measures

Primary Outcomes (1)

• 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.

  Within 30 minutes of Spontaneous Breathing Trial (SBT)

Secondary Outcomes (6)

• Reintubation Rate within 48 hours

  Within 48 hours after extubation.

• Ventilator-Free Days by Day 7

  Within 7 days after extubation.

• ICU Mortality

  during the ICU stay or within 24 hours following transfer out of the ICU

• Reintubation rate within 48 hours after extubation

  within the 48 hours after extubation

• Ventilator-Free Days at Day 7 (VFD-7)

  Within 7 days after extubation

Study Arms (1)

Conventional method Respiratory Drive group

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

Device: electrical impedance tomography

Interventions

electrical impedance tomography DEVICE

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

Conventional method Respiratory Drive group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ruijin Hospital: lead
• Fujian Provincial Hospital: collaborator
• Peking Union Medical College Hospital: collaborator

Study Sites (3)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Location

Fujian Provincial Hospital

Fuzhou, Fujian, 200025, China

Location

Department of Critical Care Medicine，Ruijin Hospital，Shanghai Jiao Tong University School of Medicine，Shanghai，China.

Shanghai, 200025, China

Location

Study Officials

• Hongping Qu

  Department of Critical Care Medicine，Ruijin Hospital，Shanghai Jiao Tong University School of Medicine

  STUDY CHAIR

• Jialin Liu

  Department of Critical Care Medicine，Ruijin Hospital，Shanghai Jiao Tong University School of Medicine

  STUDY DIRECTOR

• rui zhang

  Department of Critical Care Medicine，Ruijin Hospital，Shanghai Jiao Tong University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2025
• First Posted: March 14, 2025
• Study Start: December 1, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: April 23, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)