Full-Course ECMO Strategy for Moderate-to-Severe ARDS

This study focuses on the establishment, clinical evaluation, and dynamic optimization of a full-course ECMO management pathway for patients with moderate-to-severe ARDS.

First, a standardized full-course ECMO management pathway will be developed based on evidence-based medicine and multidisciplinary collaboration. The pathway will cover the entire clinical process, including assessment of ECMO indications, ECMO initiation, maintenance management, complication prevention and management, ECMO weaning, rehabilitation, and follow-up. The aim is to standardize key clinical decision points and improve the homogeneity of ECMO care across participating centers.

Second, the clinical effectiveness of the full-course ECMO management pathway will be evaluated through a multicenter, real-world, before-and-after clinical study. Patients treated before implementation of the pathway will serve as the control group, while patients treated after implementation will receive care according to the standardized pathway. The study will systematically assess whether implementation of the pathway improves clinical outcomes in patients with moderate-to-severe ARDS receiving ECMO.

Third, a closed-loop system for pathway implementation and dynamic optimization will be established. This system will follow a "pathway-data-feedback-improvement" model. Based on updated guidelines and evidence generated from this study, key intervention points, process key performance indicators, and quality indicators will be defined. A unified electronic pathway and data dictionary will be used across participating centers. Physicians, respiratory therapists, and nurses will record key parameters and reasons for pathway deviations through an intelligent data platform.

Regular multidisciplinary reviews will be conducted monthly or quarterly to evaluate pathway implementation, identify process barriers, analyze center-level variation, and review the root causes of adverse events. Statistical process control, cumulative sum analysis, and risk-adjusted benchmarking may be used to support quality monitoring and continuous improvement. Based on the accumulated clinical data and evidence, living clinical guidance or practice recommendations will be updated iteratively.

The final goal of this study is to establish a reproducible, traceable, and evaluable full-course ECMO management pathway for patients with moderate-to-severe ARDS, thereby supporting standardized and homogeneous ECMO care across multiple centers.

• 28-Day All-Cause Mortality [Срок оценки: 28 days after ECMO initiation]
• Successful Liberation From Mechanical Ventilation [Срок оценки: From initiation of invasive mechanical ventilation to 7 days after liberation from mechanical ventilation, assessed up to hospital discharge]
• ICU Mortality [Срок оценки: From ICU admission to ICU discharge or death, assessed up to 90 days after ECMO initiation]
• ICU Length of Stay [Срок оценки: From ICU admission to ICU discharge, assessed up to 90 days after ECMO initiation]
• Respiratory Support at ICU Discharge [Срок оценки: At ICU discharge, assessed up to 90 days after ECMO initiation]
• Hospital Mortality [Срок оценки: From hospital admission to hospital discharge or death, assessed up to 90 days after ECMO initiation]
• Hospital Length of Stay [Срок оценки: From hospital admission to hospital discharge, assessed up to 90 days after ECMO initiation]
• Respiratory Support at Hospital Discharge [Срок оценки: At hospital discharge, assessed up to 90 days after ECMO initiation]
• Incidence of ECMO-Related Complications [Срок оценки: From ECMO initiation to 48 hours after ECMO decannulation]
• Major Bleeding Events [Срок оценки: From ECMO initiation to 48 hours after ECMO decannulation]
• Minor Bleeding Events [Срок оценки: From ECMO initiation to ECMO decannulation]
• Patient-Related Thrombotic Events [Срок оценки: From ECMO initiation to 48 hours after ECMO decannulation]