ARDS
Conditions
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
Study design
Eligibility
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
| Measure | Time frame | Description |
|---|---|---|
| recruitment success percent | From enrollment to the end of treatment at 7 days | recruitment( ≥10% compliance improvement ) and Re-check the blood gas ≥20 mmHg PaO₂/FiO₂ increase mean success |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 28-day mortality | From enrollment to the end of treatment at 28 days | Statistical analysis of 28-day mortality |
| Ventilator-free days at Day 28 | From enrollment to the end of treatment at 28 days | Number of days alive and free from mechanical Ventilation with in the first days after enrollment |
| Length of ICU stay | From enrollment to the end of treatment at 7 days | Length of ICU stay in days |
| Change in Sequential Organ Failure Assessment (SOFA) score from baseline to day 7 | From enrollment to the end of treatment at 7 days | Change in Sequential Organ Failure Assessment (SOFA) score from baseline to day 7 |
Countries
China
Contacts
Department of Critical Care Medicine,Ruijin Hospital,Shanghai Jiao Tong University School of Medicine
Department of Geriatrics,Ruijin Hospital,Shanghai Jiao Tong University School of Medicine
Department of Critical Care Medicine,Ruijin Hospital