Acute Respiratory Distress Syndrome (ARDS) Clinical Trials

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Establishment and Evaluation of a Full-Course ECMO Management Strategy for Patients With Moderate-to-Severe ARDS

Status: Recruiting
Location: See all (39) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 1\. Age 18 years or older. 2. Diagnosed with moderate-to-severe acute respiratory distress syndrome according to the global definition of ARDS.

Locations
Other Locations
China
Beijing Anzhen Hospital, Capital Medical University
RECRUITING
Beijing
The Second Hospital of Jilin University
NOT_YET_RECRUITING
Changchun
West China Tianfu Hospital, Sichuan University
NOT_YET_RECRUITING
Chengdu
The First People's Hospital of Chenzhou
NOT_YET_RECRUITING
Chenzhou
The Second Affiliated Hospital of Dalian Medical University
RECRUITING
Dalian
Fuzhou University Affiliated Provincial Hospital
RECRUITING
Fuzhou
The First Affiliated Hospital of Guangzhou Medical University
RECRUITING
Guangzhou
The First Affiliated Hospital of Harbin Medical University
NOT_YET_RECRUITING
Ha’erbin
The Second Affiliated Hospital of Harbin Medical University
RECRUITING
Ha’erbin
Affiliated Hangzhou First People's Hospital of Westlake University School of Medicine
NOT_YET_RECRUITING
Hangzhou
The Second Affiliated Hospital of Zhejiang University School of Medicine
RECRUITING
Hangzhou
Huai'an First People's Hospital
NOT_YET_RECRUITING
Huai'an
Qilu Hospital of Shandong University
RECRUITING
Jinan
The First People's Hospital of Kunshan
NOT_YET_RECRUITING
Kunshan
The First Hospital of Lanzhou University
NOT_YET_RECRUITING
Lanzhou
The First People's Hospital of Lianyungang
NOT_YET_RECRUITING
Lianyungang
Liuzhou People's Hospital
RECRUITING
Liuzhou
Jiangsu Province Hospital
NOT_YET_RECRUITING
Nanjing
Nanjing Drum Tower Hospital (The Affiliated Hospital of Nanjing University Medical School)
RECRUITING
Nanjing
Zhongda Hospital Southeast University
RECRUITING
Nanjing
The First Affiliated Hospital of Guangxi Medical University
NOT_YET_RECRUITING
Nanning
The People's Hospital of Guangxi Zhuang Autonomous Region
NOT_YET_RECRUITING
Nanning
The Second Affiliated Hospital of Guangxi Medical University
NOT_YET_RECRUITING
Nanning
Affiliated Hospital of Nantong University
NOT_YET_RECRUITING
Nantong
General Hospital of Ningxia Medical University
NOT_YET_RECRUITING
Ningxiang
The Affiliated Hospital of Qinghai University
NOT_YET_RECRUITING
Qinghai
Quzhou People's Hospital
RECRUITING
Quzhou
Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital (SAMS&SPPH, Affiliated Hospital of UESTC)
RECRUITING
Sichuan
Suining Central Hospital
NOT_YET_RECRUITING
Suining
The First Affiliated Hospital of Soochow University
NOT_YET_RECRUITING
Suzhou
Wuxi People's Hospital
RECRUITING
Wuxi
The Second Affiliated Hospital of Xi'an Jiaotong University
RECRUITING
Xi'an
The First Affiliated Hospital of Xiamen University
NOT_YET_RECRUITING
Xiamen
Xinyang Central Hospital
NOT_YET_RECRUITING
Xinyang
The Affiliated Hospital of Xuzhou Medical Universit
NOT_YET_RECRUITING
Xuzhou
Northern Jiangsu People's Hospital
NOT_YET_RECRUITING
Yangzhou
Henan Provincial People's Hospital
RECRUITING
Zhengzhou
The First Affiliated Hospital of Zhengzhou University
NOT_YET_RECRUITING
Zhengzhou
Zhongshan Hospital of Traditional Chinese Medicine
NOT_YET_RECRUITING
Zhongshan
Contact Information
Primary
yingzi Huang, M.D.
yz_huang@126.com
18271428804
Time Frame
Start Date: 2026-06-16
Estimated Completion Date: 2030-02-28
Participants
Target number of participants: 500
Treatments
Other: Pre-Implementation Usual Care
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.
Experimental: Post-Implementation ECMO Management Pathway
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.
Sponsors
Leads: Southeast University, China

This content was sourced from clinicaltrials.gov