Electrical Impedance Tomography-Based Dynamic Ventilation-Perfusion Functional Phenotype Trajectory in Acute Respiratory Distress Syndrome

NCT07370610 | Active Not Recruiting DMC

• 1 other identifier: 20250516
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Acute Respiratory Distress Syndrome (ARDS) is characterized by severe hypoxemia and extensive lung injury. Recent studies indicate that lung functional phenotypes - particularly the distribution and evolution of lung perfusion - may be closely related to patient outcomes. Electrical impedance tomography (EIT) offers non-invasive, bedside, real-time monitoring of lung perfusion patterns and enables classification into distinct phenotypes and trajectory types over the course of illness. To date, limited data exist on perfusion phenotype trajectories in ARDS patients and their relationship with clinical outcomes. This study seeks to characterize dynamic lung dynamic ventilation-perfusion functional Phenotype using EIT and explore their prognostic significance. Objectives Primary Objective: To identify lung perfusion phenotype trajectories in ARDS patients using EIT and assess their association with 28-day mortality. Secondary Objectives:

• To determine the relationship between different trajectory types and improvements in oxygenation and respiratory mechanics.
• To investigate how ventilator settings (PEEP, driving pressure) interact with perfusion changes.
• To support individualized mechanical ventilation strategies based on Ventilation-Perfusion Functional Phenotype monitoring

Conditions

ARDS; Mechanically Ventilated Patients

Keywords

eit; lung perfusion patterns; Acute Respiratory Distress Syndrome

Outcome Measures

Primary Outcomes (1)

• 28-day all-cause mortality

  From enrollment to 28 days

Secondary Outcomes (4)

• Time to oxygenation improvement (PaO₂/FiO₂ > 200 mmHg)

  From enrollment until the event occurs, assessed up to 14 days

• Duration of mechanical ventilation

  From intubation until successful extubation, assessed up to 28 days or until ICU discharge/death

• ICU length of stay

  From ICU admission until discharge from ICU, assessed up to 60 days

• Interaction between phenotype trajectory and ventilator settings (PEEP, driving pressure)

  Daily during EIT monitoring period, up to 14 days

Study Arms (1)

EIT Monitoring group

* 16-electrode belt positioned around the thorax * Daily perfusion assessment (10 min recording) at baseline and after major clinical interventions (e.g., PEEP change, position change) * Pulmonary perfusion analysis will primarily be based on the pulse-synchronous impedance signal derived from EIT during brief respiratory pauses, estimating regional perfusion from cardiac-related impedance changes. When signal quality is insufficient, or in cases of significant arrhythmia or other conditions affecting pulse signal detection, the saline indicator method will be applied for validation or calibration. * This involves rapid intravenous bolus injection of 10-20 mL room-temperature saline, using the induced transient conductivity change as a perfusion marker:Ventilation-Perfusion Functional Phenotype will be derived by combining EIT-based tidal and pulsatile impedance changes, calculating the regional V/Q ratio.

Device: EIT Monitoring

Interventions

EIT Monitoring DEVICE

* 16-electrode belt positioned around the thorax * Daily perfusion assessment (10 min recording) at baseline and after major clinical interventions (e.g., PEEP change, position change) * Pulmonary perfusion analysis will primarily be based on the pulse-synchronous impedance signal derived from EIT during brief respiratory pauses, estimating regional perfusion from cardiac-related impedance changes. When signal quality is insufficient, or in cases of significant arrhythmia or other conditions affecting pulse signal detection, the saline indicator method will be applied for validation or calibration. * This involves rapid intravenous bolus injection of 10-20 mL room-temperature saline, using the induced transient conductivity change as a perfusion marker:Ventilation-Perfusion Functional Phenotype will be derived by combining EIT-based tidal and pulsatile impedance changes, calculating the regional V/Q ratio.

EIT Monitoring 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

ARDS Mechanically Ventilated Patients

You may qualify if:

• ge ≥ 18 years
• Moderate-to-severe ARDS (Berlin definition, PaO₂/FiO₂ ≤ 200 mmHg)
• Mechanically ventilated and eligible for EIT monitoring
• Informed consent obtained from patient or legal surrogate

You may not qualify if:

• Pregnancy
• Presence of implanted metallic devices interfering with EIT (e.g., pacemaker)
• Severe chest wall deformity or skin condition preventing electrode placement
• Expected survival \< 24 hours

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

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

Shanghai, Shanghai Municipality, 200025, China

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Officials

• Hongping Qu

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

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 28 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2026
• First Posted: January 27, 2026
• Study Start: January 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: April 13, 2026

Record last verified: 2026-01

Locations

CN (1)