An interventional study of Full-Course ECMO Management Pathway and Usual Care in Acute Respiratory Distress Syndrome, sponsored by Southeast University, China. Recruiting at 39 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-27.
Sponsored by Southeast University, China · Not applicable, Interventional, and Treatment
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.
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.
1,387 studies on the registry are indexed under Respiratory Distress Syndrome; 283 are open to participants now.
This study's planned enrollment of 500 is above the median of 60 across 822 interventional studies indexed under Respiratory Distress Syndrome.
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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.
Participants in this arm are patients with moderate-to-severe ARDS who received ECMO before implementation of the standardized full-course ECMO management pathway. Clinical care will be provided according to usual practice at each participating center, including ECMO initiation, maintenance, complication management, weaning, and rehabilitation based on local protocols and clinician judgment.
Other: Usual Care
Participants in this arm are patients with moderate-to-severe ARDS who receive ECMO after implementation of the standardized full-course ECMO management pathway. Clinical care will follow the pathway covering assessment of ECMO indications, ECMO initiation, maintenance management, complication prevention and management, weaning assessment, rehabilitation, and follow-up. Individualized adjustments are allowed according to patient condition, and pathway deviations will be recorded.
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 according to patient condition, and pathway deviations will be recorded for quality improvement and subsequent analysis.
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.
90-Day All-Cause Mortality
Time frame: From ECMO initiation to 90 days after ECMO initiation
28-Day All-Cause Mortality
The proportion of participants who die from any cause within 28 days after ECMO initiation will be compared between the pre-implementation usual care group and the post-implementation ECMO management pathway group.
Time frame: 28 days after ECMO initiation
Successful Liberation From Mechanical Ventilation
Successful liberation from mechanical ventilation is defined as survival without reintubation or death within 7 days after extubation in patients without tracheostomy, or survival without reconnection to mechanical ventilation or death within 7 days afte
Time frame: From initiation of invasive mechanical ventilation to 7 days after liberation from mechanical ventilation, assessed up to hospital discharge
ICU Mortality
The proportion of participants who die during the ICU stay will be compared between the pre-implementation usual care group and the post-implementation ECMO management pathway group.
Time frame: From ICU admission to ICU discharge or death, assessed up to 90 days after ECMO initiation
ICU Length of Stay
ICU length of stay is defined as the number of days from ICU admission to ICU discharge or death.
Time frame: From ICU admission to ICU discharge, assessed up to 90 days after ECMO initiation
Respiratory Support at ICU Discharge
Respiratory support status at ICU discharge will be recorded, including tracheostomy, invasive mechanical ventilation, noninvasive ventilation or high-flow nasal cannula, conventional oxygen therapy, or no oxygen therapy.
Time frame: At ICU discharge, assessed up to 90 days after ECMO initiation
Hospital Mortality
The proportion of participants who die during hospitalization will be compared between the pre-implementation usual care group and the post-implementation ECMO management pathway group.
Time frame: From hospital admission to hospital discharge or death, assessed up to 90 days after ECMO initiation
Hospital Length of Stay
Hospital length of stay is defined as the number of days from hospital admission to hospital discharge or death.
Time frame: From hospital admission to hospital discharge, assessed up to 90 days after ECMO initiation
Respiratory Support at Hospital Discharge
Respiratory support status at hospital discharge will be recorded, including tracheostomy, invasive mechanical ventilation, noninvasive ventilation or high-flow nasal cannula, conventional oxygen therapy, or no oxygen therapy.
Time frame: At hospital discharge, assessed up to 90 days after ECMO initiation
Incidence of ECMO-Related Complications
The incidence of ECMO-related complications will be compared between the pre-implementation usual care group and the post-implementation ECMO management pathway group. ECMO-related complications include major bleeding, minor bleeding, mechanical or circuit thrombosis, patient-related thrombosis, hospital-acquired infection during ECMO, hemolysis, cannulation-related complications, acute kidney injury, and oxygenator replacement.
Time frame: From ECMO initiation to 48 hours after ECMO decannulation
Major Bleeding Events
Major bleeding is defined as bleeding that meets at least one of the following criteria: life-threatening bleeding, including intracranial bleeding, retroperitoneal bleeding, cardiac tamponade, or bleeding leading to hemorrhagic shock; bleeding requiring surgical intervention; or transfusion of at least 2 units of red blood cells within 24 hours due to active bleeding.
Time frame: From ECMO initiation to 48 hours after ECMO decannulation
Minor Bleeding Events
Mechanical or circuit thrombosis is defined as thrombus formation observed or diagnosed within the extracorporeal circuit during ECMO support, including thrombosis in the ECMO oxygenator, pump head, tubing, connectors, or other circuit components.
Time frame: From ECMO initiation to ECMO decannulation
Patient-Related Thrombotic Events
Patient-related thrombotic events are defined as thrombotic or embolic events occurring within the patient's vascular system and confirmed by clinical findings, imaging, or autopsy. Events include deep vein thrombosis, pulmonary embolism, and ischemic stroke.
Time frame: From ECMO initiation to 48 hours after ECMO decannulation
Hospital-Acquired Infection During ECMO
Hospital-acquired infection during ECMO is defined as infection occurring more than 24 hours after ECMO initiation and up to 48 hours after ECMO decannulation. Infection sites include bloodstream infection, respiratory tract infection or ventilator-associated pneumonia, mediastinitis, cannulation-site or surgical-site infection, urinary tract infection, or other documented infection sites.
Time frame: From 24 hours after ECMO initiation to 48 hours after ECMO decannulation
Hemolysis During ECMO
Hemolysis is defined as plasma-free hemoglobin greater than 500 mg/L, equivalent to greater than 50 mg/dL, after ECMO cannulation.
Time frame: From ECMO initiation to ECMO decannulation
Cannulation-Related Complications
Cannulation-related complications include limb ischemia, pseudoaneurysm, arteriovenous fistula, vascular dissection, or other vascular complications related to ECMO cannulation. Limb ischemia is defined as impaired distal perfusion of the cannulated limb requiring clinical evaluation or intervention.
Time frame: From ECMO cannulation to 48 hours after ECMO decannulation
Acute Kidney Injury During ECMO
Acute kidney injury during ECMO will be assessed according to KDIGO criteria and classified as stage 1, stage 2, or stage 3. The need for continuous renal replacement therapy will also be recorded.
Time frame: From ECMO initiation to ECMO decannulation
Oxygenator Replacement
Oxygenator replacement is defined as replacement of the ECMO oxygenator for any reason during ECMO support, including oxygenator thrombosis, gas exchange dysfunction, increased transmembrane pressure, hemolysis, or other clinical indications.
Time frame: From ECMO initiation to ECMO decannulation
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