Full-Course ECMO Strategy for Moderate-to-Severe ARDS
ConditionAcute Respiratory Distress Syndrome
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSoutheast University, China
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
1. Age 18 years or older. 2. Diagnosed with moderate-to-severe acute respiratory distress syndrome according to the global definition of ARDS.
Disqualifiers
None
Trial design
Design model
Sequential
Treatments tested in this trial
Full-Course ECMO Management Pathway
Other interventionThe 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
Other interventionUsual 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.
Treatment groups
500 Participants
are divided into 2 treatment groupsGroup A: Pre-Implementation Usual CareOther 1 intervention
Group B: Post-Implementation ECMO Management PathwayExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
90-Day All-Cause Mortality
Time frame
From ECMO initiation to 90 days after ECMO initiationSecondary outcomes
1
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 initiation2
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 discharge3
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 initiation4
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 initiationSponsors and contacts
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Source ClinicalTrials.gov