Acute Respiratory Distress SyndromeNCT07726953
Full-Course ECMO Strategy for Moderate-to-Severe ARDS
A study testing Full-Course ECMO Management Pathway in people with Acute Respiratory Distress Syndrome, run by Southeast University, China at 39 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Distress Syndrome
- What is being tested?
- Full-Course ECMO Management Pathway
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 39 sitesChina
- Study dates
- 16 Jun 2026to 28 Feb 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Age 18 years or older. 2. Diagnosed with moderate-to-severe acute respiratory distress syndrome according to the global definition of ARDS.
Who cannot join
- 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.
Trial locations and contacts
39 sites in 1 country. Contact the study team or a site near you to ask about taking part.
39 sites in 1 country
China39 sites, 39 recruiting
- Recruiting
Beijing Anzhen Hospital, Capital Medical University
Beijing
Zhongtao Du
- Not yet recruiting
The Second Hospital of Jilin University
Changchun
- Not yet recruiting
West China Tianfu Hospital, Sichuan University
Chengdu
- Not yet recruiting
The First People's Hospital of Chenzhou
Chenzhou
- Recruiting
The Second Affiliated Hospital of Dalian Medical University
Dalian
- Recruiting
Fuzhou University Affiliated Provincial Hospital
Fuzhou
Shang
- Recruiting
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou
Yan Wang
- Not yet recruiting
The First Affiliated Hospital of Harbin Medical University
Ha’erbin
- Recruiting
The Second Affiliated Hospital of Harbin Medical University
Ha’erbin
Hongliang Wang
- Not yet recruiting
Affiliated Hangzhou First People's Hospital of Westlake University School of Medicine
Hangzhou
- Recruiting
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou
Xie
- Not yet recruiting
Huai'an First People's Hospital
Huai'an
- Recruiting
Qilu Hospital of Shandong University
Jinan
Hao Wang
- Not yet recruiting
The First People's Hospital of Kunshan
Kunshan
- Not yet recruiting
The First Hospital of Lanzhou University
Lanzhou
- Not yet recruiting
The First People's Hospital of Lianyungang
Lianyungang
- Recruiting
Liuzhou People's Hospital
Liuzhou
Wenfang Jiang
- Not yet recruiting
Jiangsu Province Hospital
Nanjing
- Recruiting
Nanjing Drum Tower Hospital (The Affiliated Hospital of Nanjing University Medical School)
Nanjing
Danjiang Dong
- Recruiting
Zhongda Hospital Southeast University
Nanjing
Xiaojing Wu, 13951876234, 36410257@qq.com
- Not yet recruiting
The First Affiliated Hospital of Guangxi Medical University
Nanning
- Not yet recruiting
The People's Hospital of Guangxi Zhuang Autonomous Region
Nanning
- Not yet recruiting
The Second Affiliated Hospital of Guangxi Medical University
Nanning
- Not yet recruiting
Affiliated Hospital of Nantong University
Nantong
- Not yet recruiting
General Hospital of Ningxia Medical University
Ningxiang
- Not yet recruiting
The Affiliated Hospital of Qinghai University
Qinghai
- Recruiting
Quzhou People's Hospital
Quzhou
- Recruiting
Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital (SAMS&SPPH, Affiliated Hospital of UESTC)
Sichuan
Hongli He
- Not yet recruiting
Suining Central Hospital
Suining
- Not yet recruiting
The First Affiliated Hospital of Soochow University
Suzhou
- Recruiting
Wuxi People's Hospital
Wuxi
Hongyang Xu
- Recruiting
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an
jing Geng
- Not yet recruiting
The First Affiliated Hospital of Xiamen University
Xiamen
- Not yet recruiting
Xinyang Central Hospital
Xinyang
- Not yet recruiting
The Affiliated Hospital of Xuzhou Medical Universit
Xuzhou
- Not yet recruiting
Northern Jiangsu People's Hospital
Yangzhou
- Recruiting
Henan Provincial People's Hospital
Zhengzhou
Huanzhang Shao
- Not yet recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou
- Not yet recruiting
Zhongshan Hospital of Traditional Chinese Medicine
Zhongshan
About this study
Official title: Establishment and Evaluation of a Full-Course ECMO Management Strategy for Patients With Moderate-to-Severe ARDS
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.
Read the detailed description
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.
- Conditions
- Acute Respiratory Distress Syndrome
- Being tested
- Full-Course ECMO Management Pathway, Usual Care
- Keywords
- Acute Respiratory Distress Syndrome, Moderate-to-Severe ARDS, Extracorporeal Membrane Oxygenation, ECMO, VV-ECMO, ECMO Management Pathway
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Full-Course ECMO Management PathwayOther
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 CareOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Pre-Implementation Usual Care | Other | 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. Receives: Other: Usual Care |
| Post-Implementation ECMO Management Pathway | Experimental | 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. Receives: Other: Full-Course ECMO Management Pathway |
What is being measured
The primary outcome is the main question the study is designed to answer.
90-Day All-Cause Mortality
Measured: From ECMO initiation to 90 days after ECMO initiation
Secondary outcomes (17)
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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From ECMO initiation to ECMO decannulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2026
- Study start16 Jun 2026
- Primary completion28 Feb 2030 (estimated)
- Study completion28 Feb 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory Distress SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Participants will be assigned according to the implementation period of the standardized full-course ECMO management pathway. Patients treated before implementation of the pathway will serve as the control group and receive usual care based on local clinical practice. Patients treated after implementation of the pathway will receive care according to the standardized full-course ECMO management pathway. No randomization will be performed.
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Southeast University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jianfeng Xie, Southeast University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07726953
- Sponsor's protocol ID
- 2026ZDSYLL081-P01
- Other IDs
- 2026ZD0555505
- Status last verified
- Jul 2026
- First submitted
- 21 Jul 2026
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishment and Evaluation of a Full-Course ECMO Management Strategy for Patients With Moderate-to-Severe ARDS
- ClinicalTrials.gov ID
- NCT07726953
- Acronym / sponsor ID
- 2026ZDSYLL081-P01
- Conditions
- Acute Respiratory Distress Syndrome
- Keywords
- Acute Respiratory Distress Syndrome, Moderate-to-Severe ARDS, Extracorporeal Membrane Oxygenation, ECMO, VV-ECMO, ECMO Management Pathway
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Southeast University, ChinaUniversity, hospital or other
- Study start
- 16 Jun 2026 (actual)
- Primary completion
- 28 Feb 2030 (estimated)
- Study completion
- 28 Feb 2030 (estimated)
- First posted
- 27 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be assigned according to the implementation period of the standardized full-course ECMO management pathway. Patients treated before implementation of the pathway will serve as the control group and receive usual care based on local clinical practice. Patients treated after implementation of the pathway will receive care according to the standardized full-course ECMO management pathway. No randomization will be performed.
| Arm | Type | Receives |
|---|---|---|
| Pre-Implementation Usual Care | Other | Other: Usual CareParticipants 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 | Experimental | Other: Full-Course ECMO Management PathwayParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. Age 18 years or older. 2. Diagnosed with moderate-to-severe acute respiratory distress syndrome according to the global definition of ARDS.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Full-Course ECMO Management PathwayThe 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. | Other | Post-Implementation ECMO Management Pathway |
| Usual CareUsual 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. | Other | Pre-Implementation Usual Care |
Primary outcome
90-Day All-Cause Mortality
Time frame: From ECMO initiation to 90 days after ECMO initiation
17 secondary outcomes
28-Day All-Cause Mortality
Time frame: 28 days after ECMO initiation
Successful Liberation From Mechanical Ventilation
Time frame: From initiation of invasive mechanical ventilation to 7 days after liberation from mechanical ventilation, assessed up to hospital discharge
ICU Mortality
Time frame: From ICU admission to ICU discharge or death, assessed up to 90 days after ECMO initiation
ICU Length of Stay
Time frame: From ICU admission to ICU discharge, assessed up to 90 days after ECMO initiation
Respiratory Support at ICU Discharge
Time frame: At ICU discharge, assessed up to 90 days after ECMO initiation
Hospital Mortality
Time frame: From hospital admission to hospital discharge or death, assessed up to 90 days after ECMO initiation
Hospital Length of Stay
Time frame: From hospital admission to hospital discharge, assessed up to 90 days after ECMO initiation
Respiratory Support at Hospital Discharge
Time frame: At hospital discharge, assessed up to 90 days after ECMO initiation
Incidence of ECMO-Related Complications
Time frame: From ECMO initiation to 48 hours after ECMO decannulation
Major Bleeding Events
Time frame: From ECMO initiation to 48 hours after ECMO decannulation
Minor Bleeding Events
Time frame: From ECMO initiation to ECMO decannulation
Patient-Related Thrombotic Events
Time frame: From ECMO initiation to 48 hours after ECMO decannulation
Hospital-Acquired Infection During ECMO
Time frame: From 24 hours after ECMO initiation to 48 hours after ECMO decannulation
Hemolysis During ECMO
Time frame: From ECMO initiation to ECMO decannulation
Cannulation-Related Complications
Time frame: From ECMO cannulation to 48 hours after ECMO decannulation
Acute Kidney Injury During ECMO
Time frame: From ECMO initiation to ECMO decannulation
Oxygenator Replacement
Time frame: From ECMO initiation to ECMO decannulation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
39 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Full-Course ECMO Management Pathway in people with Acute Respiratory Distress Syndrome, run by Southeast University, China at 39 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 39 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact yingzi Huang, M.D. (18271428804, yz_huang@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
90-Day All-Cause Mortality (time frame: From ECMO initiation to 90 days after ECMO initiation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2026.