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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06823804
Enrollment
120
Registered
2025-02-12
Start date
2022-12-01
Completion date
2024-12-31
Last updated
2026-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ARDS

Keywords

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

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.

Detailed description

1. Background and Rationale ARDS is associated with heterogeneous lung collapse. The recruitment-to inflation (R/I) ratio has emerged as an index of recruitability, but is usually assessed globally. Electrical impedance tomography (EIT) enables regional assessment of ventilation and may provide more precise determinations of recruitable lung regions, particularly dorsal areas. 2. Objectives Primary objective: To compare the predictive value of regional (dorsal and ventral) versus global R/I for recruitment success in moderate-severe ARDS. Secondary objectives: To classify recruitment phenotypes and evaluate associations with oxygenation, compliance improvement, ventilator-free days, ICU length of stay, and 28-day mortality. 3. Study Design Prospective, single-centre observational cohort study in ICU patients with moderate-severe ARDS. All eligible patients undergo standardised recruitment maneuver and EIT monitoring. 4. Study Setting Ruijin Hospital, Shanghai Jiao Tong University School of Medicine ICU, December 2022 - December 2024. 5. Intervention 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%. 6. Measurements EIT-derived ΔEELI in dorsal and ventral regions Regional and global compliance (Crec and Crs) R/I calculated: Crec/Crs at baseline PEEP Airway opening pressure by low-flow inflation method Primary outcome: recruitment success (≥10% compliance improvement + ≥20 mmHg PaO₂/FiO₂ increase) Secondary: ventilator-free days, ICU LOS, 28-day mortality, dynamic strain 7. Statistical Analysis Plan Distribution check by Shapiro-Wilk. Paired tests for within-patient comparisons. ROC curves and Youden index for cut-off selection. Multivariate regression for mortality risk factors. Bonferroni correction for multiple comparisons. 8. Safety Monitoring Terminate RM if: MAP \<65 mmHg, SpO₂ \<88%, arrhythmia onset, dynamic strain \>0.6.

Interventions

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%.

Sponsors

Ruijin Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
recruitment success percentFrom enrollment to the end of treatment at 7 daysrecruitment( ≥10% compliance improvement ) and Re-check the blood gas ≥20 mmHg PaO₂/FiO₂ increase mean success

Secondary

MeasureTime frameDescription
28-day mortalityFrom enrollment to the end of treatment at 28 daysStatistical analysis of 28-day mortality
Ventilator-free days at Day 28From enrollment to the end of treatment at 28 daysNumber of days alive and free from mechanical Ventilation with in the first days after enrollment
Length of ICU stayFrom enrollment to the end of treatment at 7 daysLength of ICU stay in days
Change in Sequential Organ Failure Assessment (SOFA) score from baseline to day 7From enrollment to the end of treatment at 7 daysChange in Sequential Organ Failure Assessment (SOFA) score from baseline to day 7

Countries

China

Contacts

STUDY_CHAIRHongping Qu

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

PRINCIPAL_INVESTIGATORJialin Liu

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

STUDY_DIRECTORrui zhang

Department of Critical Care Medicine,Ruijin Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 24, 2026