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

Recruiting now · Not applicable

Conditions studied: Acute Respiratory Distress Syndrome

In brief

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.

Key facts

Study ID

NCT07726953

Run by

Southeast University, China

People needed

500

Starts

2026-06-16

Expected to finish

2030-02-28

Last updated by the study team

2026-07-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 1. 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.

Where it is running

• Beijing Anzhen Hospital, Capital Medical University — Beijing, China (enrolling)
• The Second Affiliated Hospital of Dalian Medical University — Dalian, China (enrolling)
• Fuzhou University Affiliated Provincial Hospital — Fuzhou, China (enrolling)
• The First Affiliated Hospital of Guangzhou Medical University — Guangzhou, China (enrolling)
• The Second Affiliated Hospital of Zhejiang University School of Medicine — Hangzhou, China (enrolling)
• The Second Affiliated Hospital of Harbin Medical University — Ha’erbin, China (enrolling)
• Qilu Hospital of Shandong University — Jinan, China (enrolling)
• Liuzhou People's Hospital — Liuzhou, China (enrolling)
• Nanjing Drum Tower Hospital (The Affiliated Hospital of Nanjing University Medical School) — Nanjing, China (enrolling)
• Zhongda Hospital Southeast University — Nanjing, China (enrolling)
• Quzhou People's Hospital — Quzhou, China (enrolling)
• Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital (SAMS&SPPH, Affiliated Hospital of UESTC) — Sichuan, China (enrolling)
• Wuxi People's Hospital — Wuxi, China (enrolling)
• The Second Affiliated Hospital of Xi'an Jiaotong University — Xi'an, China (enrolling)
• Henan Provincial People's Hospital — Zhengzhou, China (enrolling)
• The First People's Hospital of Lianyungang — Lianyungang, China
• The First Affiliated Hospital of Zhengzhou University — Zhengzhou, China
• Jiangsu Province Hospital — Nanjing, China
• The First Affiliated Hospital of Xiamen University — Xiamen, China
• Xinyang Central Hospital — Xinyang, 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

Full record on ClinicalTrials.gov

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