Full-Course ECMO Strategy for Moderate-to-Severe ARDS
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Full-Course ECMO Management Pathway, Usual Care.
- Who it may be relevant to
- Registry conditions: Acute Respiratory Distress Syndrome. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Establishment and Evaluation of a Full-Course ECMO Management Strategy for Patients With Moderate-to-Severe ARDS
Overview
China faces major challenges in the ECMO management of patients with moderate-to-severe ARDS, including substantial heterogeneity in clinical practice, low weaning success rates, and high complication rates. A key underlying reason is the lack of a standardized full-course management pathway that is applicable to real-world clinical practice in China. This study focuses on the construction and evidence-based evaluation of a precision full-course ECMO management pathway for patients with moderate-to-severe ARDS, aiming to address fragmented care processes and delayed quality improvement. The study includes three main components. First, multidisciplinary consensus and evidence-based findings will be integrated to develop a standardized management pathway covering the full chain of assessment, initiation, maintenance, weaning, and rehabilitation. Second, a nationwide multicenter real-world study with a before-and-after design will be conducted to systematically evaluate the clinical effectiveness of this pathway in reducing mortality and complications and improving patient outcomes. Third, a closed-loop dynamic optimization system based on "pathway-data-feedback-improvement" will be established. With the support of an intelligent data platform and multidisciplinary review mechanisms, the pathway will be continuously updated and refined. Through this study, a reproducible, traceable, and evaluable full-course ECMO management strategy is expected to be established. The study will also build a national collaborative research network and support the development of living clinical guidance, promoting the transition of ECMO care in China from experience-based practice toward standardized, homogeneous, and intelligent management, and providing a key technical framework and practical model for improving critical care.
Detailed description
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.
Interventions
- Other Full-Course ECMO Management Pathway
The intervention is a standardized full-course ECMO management pathway for patients with moderate-to-severe ARDS. The pathway covers assessment of ECMO indications, ECMO initiation, cannulation and anticoagulation strategies, mechanical ventilation management, hemodynamic and fluid management, infection prevention, analgesia and sedation, nutrition and rehabilitation, complication prevention and management, weaning assessment, discharge, and follow-up. Individualized adjustments are allowed acco - Other Usual Care
Usual care refers to ECMO management provided before implementation of the standardized full-course ECMO management pathway. Clinical decisions are made according to local practice and clinician judgment at each participating center.
Primary outcome measures
- 90-Day All-Cause Mortality [Time frame: From ECMO initiation to 90 days after ECMO initiation]
Secondary outcome measures (12)
- 28-Day All-Cause Mortality [Time frame: 28 days after ECMO initiation]
- Successful Liberation From Mechanical Ventilation [Time frame: From initiation of invasive mechanical ventilation to 7 days after liberation from mechanical ventilation, assessed up to hospital discharge]
- ICU Mortality [Time frame: From ICU admission to ICU discharge or death, assessed up to 90 days after ECMO initiation]
- ICU Length of Stay [Time frame: From ICU admission to ICU discharge, assessed up to 90 days after ECMO initiation]
- Respiratory Support at ICU Discharge [Time frame: At ICU discharge, assessed up to 90 days after ECMO initiation]
- Hospital Mortality [Time frame: From hospital admission to hospital discharge or death, assessed up to 90 days after ECMO initiation]
- Hospital Length of Stay [Time frame: From hospital admission to hospital discharge, assessed up to 90 days after ECMO initiation]
- Respiratory Support at Hospital Discharge [Time frame: At hospital discharge, assessed up to 90 days after ECMO initiation]
- Incidence of ECMO-Related Complications [Time frame: From ECMO initiation to 48 hours after ECMO decannulation]
- Major Bleeding Events [Time frame: From ECMO initiation to 48 hours after ECMO decannulation]
- Minor Bleeding Events [Time frame: From ECMO initiation to ECMO decannulation]
- Patient-Related Thrombotic Events [Time frame: From ECMO initiation to 48 hours after ECMO decannulation]
Eligibility criteria
Inclusion criteria
- 1\. Age 18 years or older. 2. Diagnosed with moderate-to-severe acute respiratory distress syndrome according to the global definition of ARDS.
Exclusion criteria
\- 1. Patients with tracheostomy before screening. 2. Patients who have received lung transplantation or are receiving venovenous extracorporeal membrane oxygenation as a bridge to lung transplantation.
3\. Patients with cardiogenic shock requiring venoarterial ECMO or venoarterial-venous ECMO support.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 39 centers
- Beijing Anzhen Hospital, Capital Medical University — Beijing
- The Second Hospital of Jilin University — Changchun
- West China Tianfu Hospital, Sichuan University — Chengdu
- The First People's Hospital of Chenzhou — Chenzhou
- The Second Affiliated Hospital of Dalian Medical University — Dalian
- Fuzhou University Affiliated Provincial Hospital — Fuzhou
- The First Affiliated Hospital of Guangzhou Medical University — Guangzhou
- Affiliated Hangzhou First People's Hospital of Westlake University School of Medicine — Hangzhou
- … and 31 more centers
Identifiers
NCT: NCT07726953 · 2026ZDSYLL081-P01 · 2026ZD0555505