Full-Course ECMO Strategy for Moderate-to-Severe ARDS
Establishment and Evaluation of a Full-Course ECMO Management Strategy for Patients With Moderate-to-Severe ARDS
2 other identifiers
interventional
500
1 country
39
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2026
Longer than P75 for not_applicable
39 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 16, 2026
CompletedFirst Submitted
Initial submission to the registry
July 21, 2026
CompletedFirst Posted
Study publicly available on registry
July 27, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 28, 2030
July 27, 2026
July 1, 2026
3.7 years
July 21, 2026
July 21, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
90-Day All-Cause Mortality
From ECMO initiation to 90 days after ECMO initiation
Secondary Outcomes (17)
28-Day All-Cause Mortality
28 days after ECMO initiation
Successful Liberation From Mechanical Ventilation
From initiation of invasive mechanical ventilation to 7 days after liberation from mechanical ventilation, assessed up to hospital discharge
ICU Mortality
From ICU admission to ICU discharge or death, assessed up to 90 days after ECMO initiation
ICU Length of Stay
From ICU admission to ICU discharge, assessed up to 90 days after ECMO initiation
Respiratory Support at ICU Discharge
At ICU discharge, assessed up to 90 days after ECMO initiation
- +12 more secondary outcomes
Study Arms (2)
Pre-Implementation Usual Care
OTHERParticipants 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.
Post-Implementation ECMO Management Pathway
EXPERIMENTALParticipants 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- \. Age 18 years or older. 2. Diagnosed with moderate-to-severe acute respiratory distress syndrome according to the global definition of ARDS.
You may not qualify if:
- \- 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.
- \. Patients with cardiogenic shock requiring venoarterial ECMO or venoarterial-venous ECMO support.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (39)
Beijing Anzhen Hospital, Capital Medical University
Beijing, China
The Second Hospital of Jilin University
Changchun, China
West China Tianfu Hospital, Sichuan University
Chengdu, China
The First People's Hospital of Chenzhou
Chenzhou, China
The Second Affiliated Hospital of Dalian Medical University
Dalian, China
Fuzhou University Affiliated Provincial Hospital
Fuzhou, China
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, China
Affiliated Hangzhou First People's Hospital of Westlake University School of Medicine
Hangzhou, China
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, China
The First Affiliated Hospital of Harbin Medical University
Ha’erbin, China
The Second Affiliated Hospital of Harbin Medical University
Ha’erbin, China
Huai'an First People's Hospital
Huai'an, China
Qilu Hospital of Shandong University
Jinan, China
The First People's Hospital of Kunshan
Kunshan, China
The First Hospital of Lanzhou University
Lanzhou, China
The First People's Hospital of Lianyungang
Lianyungang, China
Liuzhou People's Hospital
Liuzhou, China
Jiangsu Province Hospital
Nanjing, China
Nanjing Drum Tower Hospital (The Affiliated Hospital of Nanjing University Medical School)
Nanjing, China
Zhongda Hospital Southeast University
Nanjing, China
The First Affiliated Hospital of Guangxi Medical University
Nanning, China
The People's Hospital of Guangxi Zhuang Autonomous Region
Nanning, China
The Second Affiliated Hospital of Guangxi Medical University
Nanning, China
Affiliated Hospital of Nantong University
Nantong, China
General Hospital of Ningxia Medical University
Ningxiang, China
The Affiliated Hospital of Qinghai University
Qinghai, China
Quzhou People's Hospital
Quzhou, China
Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital (SAMS&SPPH, Affiliated Hospital of UESTC)
Sichuan, China
Suining Central Hospital
Suining, China
The First Affiliated Hospital of Soochow University
Suzhou, China
Wuxi People's Hospital
Wuxi, China
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an, China
The First Affiliated Hospital of Xiamen University
Xiamen, China
Xinyang Central Hospital
Xinyang, China
The Affiliated Hospital of Xuzhou Medical Universit
Xuzhou, China
Northern Jiangsu People's Hospital
Yangzhou, China
Henan Provincial People's Hospital
Zhengzhou, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, China
Zhongshan Hospital of Traditional Chinese Medicine
Zhongshan, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor, Director of ICU
Study Record Dates
First Submitted
July 21, 2026
First Posted
July 27, 2026
Study Start
June 16, 2026
Primary Completion (Estimated)
February 28, 2030
Study Completion (Estimated)
February 28, 2030
Last Updated
July 27, 2026
Record last verified: 2026-07