Electrical Impedance Tomography-Derived Dorsal Recruitment-to-Inflation Ratio Identifies PEEP Responsiveness and Risk Phenotypes in ARDS

NCT06823804 | Completed DMC

• 1 other identifier: 2022325
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

In the treatment of critically ill patients, mechanical ventilation is a key link, and appropriate mechanical ventilation strategies can open the alveoli and improve oxygenation, while inappropriate mechanical ventilation can increase lung injury and seriously affect the prognosis. Ventilator-related lung injury is mainly concentrated in barotrauma, volumetric injury, shear injury, and biological injury, and the monitoring of respiratory ventilation to the level of local ventilation can help to better assess the state of alveolar opening and alveolar collapse, and help to understand the uniformity of gas distribution in the lungs, which is closely related to lung injury. However, how to achieve simple, bedside and real-time lung ventilation and lung volume assessment in clinical work has always been a difficult problem to be overcome. This study intends to explore the changes of local ventilation and blood flow in the lungs during PEEP trail in patients with ARDS monitored by EIT.

Conditions

ARDS

Keywords

ventilation/perfusion ratio; Electrical impedance tomography; Acute Respiratory Distress Syndrome

Outcome Measures

Primary Outcomes (1)

• recruitment success percent

  recruitment( ≥10% compliance improvement ) and Re-check the blood gas ≥20 mmHg PaO₂/FiO₂ increase mean success

  From enrollment to the end of treatment at 7 days

Secondary Outcomes (4)

• 28-day mortality

  From enrollment to the end of treatment at 28 days

• Ventilator-free days at Day 28

  From enrollment to the end of treatment at 28 days

• Length of ICU stay

  From enrollment to the end of treatment at 7 days

• Change in Sequential Organ Failure Assessment (SOFA) score from baseline to day 7

  From enrollment to the end of treatment at 7 days

Study Arms (1)

evaluate the feasibility of using EIT to calculate regional recruitment-to-inflation (R/I) ratios

Regional R/I ratios were computed for the global lung, dorsal (dependent), and ventral (non-dependent) regions of interest (ROIs), which were defined as 50% of the ventro-dorsal lung diameter based on EIT imaging.compare the predictive value of regional (dorsal and ventral) versus global R/I for recruitment success in moderate-severe ARDS.

Diagnostic Test: Electrical Impedance tomography Monitoring

Interventions

Electrical Impedance tomography Monitoring DIAGNOSTIC_TEST

Standardized PEEP step maneuver from 5 → 15 cmH₂O, maintained for 3 minutes. Continuous EIT monitoring of regional compliance, oxygenation, hemodynamics. Dynamic strain cutoff (\>0.6) or adverse events terminate the maneuver. Ventilation mode: volume control, tidal volume 4-6 mL/kg predicted body weight, plateau ≤28-30 cmH₂O, FiO₂ titrated for SpO₂ 88-92%.

evaluate the feasibility of using EIT to calculate regional recruitment-to-inflation (R/I) ratios

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

This study included adult patients (≥18 years) with moderate-to-severe acute respiratory distress syndrome (ARDS) who were receiving invasive mechanical ventilation in the intensive care unit (ICU) of Ruijin Hospital. All enrolled patients met the Berlin definition of ARDS and had a PaO₂/FiO₂ ratio ≤200 mmHg within 6 hours of screening. A total of 120 patients were consecutively enrolled from December 2022 to December 2024. Patients were stratified by airway closure status for subgroup analyses.

You may qualify if:

• Patients who meet the Berlin definition of ARDS and have been treated with mechanical ventilation (clinical diagnosis of ARDS by the attending ICU physician)
• PaO₂/FiO₂ ≤200 mmHg

You may not qualify if:

• Age\< 18 or \>90 years
• Pneumothorax, pneumomediastinum
• Hemodynamic instability (rising vasopressor need in \<6h)
• Contraindications to RM or EIT

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

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

Shanghai, Shanghai Municipality, 200025, China

Location

MeSH Terms

Conditions

Respiratory Aspiration; Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lung Diseases

Study Officials

• Hongping Qu

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

  STUDY CHAIR

• Jialin Liu

  Department of Geriatrics，Ruijin Hospital，Shanghai Jiao Tong University School of Medicine

  PRINCIPAL INVESTIGATOR

• rui zhang

  Department of Critical Care Medicine，Ruijin Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 30 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 25, 2024
• First Posted: February 12, 2025
• Study Start: December 1, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: April 23, 2026

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)