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RecruitingNCT06231446Updated Jan 30, 2024

Extracorporeal Membrane Oxygenation for Respiratory Failure Patients

An observational study in Respiratory Failure Patients Treated With ECMO, sponsored by China-Japan Friendship Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-01-30.

Sponsored by China-Japan Friendship Hospital · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2024, 1 year 10 months ago, but the record still lists the study as recruiting.
  • Started Oct 2022; still recruiting 3 years 11 months later.
Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
400
Ages
18 Years to 80 Years
Sex
All
01

Study summary

The present study is a multicentre cohort study. Respiratory failure patients treated with extracorporeal membrane oxygenation (ECMO) were enrolled. Clinical data before and during ECMO treatment were collected. Clinical data before and during ECMO treatment were collected. By this retrospective clinical data and prospective study, to observe the current status of respiratory failure patients treated with ECMO in China, analyze the clinical characteristics and prognosis of patients, and explore the clinical prevention and treatment strategies of major complications of ECMO.

Read the detailed description

Extracorporeal membrane oxygenation (ECMO) is the ultimate life support for critically ill patients. However, ECMO was developed relatively late in China, and the large number of applications in the field of respiratory failure originated from the 2009 H1N1 influenza epidemic in China. Since then, the number of respiratory failure patients with ECMO has increased year by year. Nevertheless, there are still many problems about ECMO therapy for respiratory failure in China, mainly as follows:(1) Lack of real-world clinical data on ECMO. Most centers do not have their own databases, lack long-term follow-up, and are unable to establish a mature ECMO quality management system. (2) Lack of ECMO-related biological sample libraries. (3) Risk factors for major complications such as thrombosis and hemorrhage, ventilator-associated pneumonia, and bloodstream infections are still unclear. At present, most of the experience in the prevention and treatment of major complications of ECMO comes from foreign studies, and clinical studies have confirmed that the sensitivity and specificity of the currently commonly used biological indicators in the prediction and early warning of complications are not ideal. Therefore, there is an urgent need to carry out research on new biomarkers based on the establishment of clinical databases and biospecimen libraries. We retrospectively collected clinical data on respiratory failure patients treated with ECMO from June 2019 from five hospitals, and prospectively enrolled respiratory failure patients treated with ECMO from October 2022 from five hospitals. By this cohort study, to establish clinical databases and biospecimen libraries, and analyze the clinical characteristics and prognosis of patients, and explore the clinical prevention and treatment strategies of major complications of ECMO.

02

Conditions studied

  • Respiratory Failure Patients Treated With ECMO
03

In context

Respiratory Insufficiency

1,650 studies on the registry are indexed under Respiratory Insufficiency; 296 are open to participants now.

This study's planned enrollment of 400 is above the median of 100 across 545 observational studies indexed under Respiratory Insufficiency.

Browse Respiratory Insufficiency studies →

Lead sponsor

China-Japan Friendship Hospital is the lead sponsor of 173 studies on the registry; 109 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Respiratory failure patients with ECMO in China-Japan Friendship Hospital, The First Affiliated Hospital of Anhui Medical University, The Second Affiliated Hospital, Zhejiang University School of Medicine and Jiangxi Provincial People's Hospital.

Inclusion criteria

  1. Age ≥ 18 years and ≤ 80 years.
  2. The patient or guardian voluntarily signs an informed consent form.

  3. If one of the following conditions is met.

    • ARDS patients: lung-protective ventilation (Vt 6ml/kg, PEEP ≥ 10cm H2O) combined with recruitment maneuver, prone position ventilation, or high frequency oscillation ventilation with PaO2/FiO2\<100 mmHg or P(A-a)O2>600 mmHg under pure oxygen inhalation; or respiratory rate>35 breaths/min, pH\<7.2 and plateau pressure>30 cmH2O, with VV-ECMO adjuvant therapy.
    • Lung transplantation patients with ECMO support during perioperative period.
    • Asthma patients: under invasive mechanical ventilation support, platform pressure >35cmH2O concomitant with severe respiratory acidosis (pH\<7.1), or unstable hemodynamics, perform VV-ECMO or ECCO2R adjuvant therapy if there is no contraindication to ECMO,
    • Chronic Obstructive Pulmonary Disease (COPD): to enable patients with severe COPD requiring invasive ventilation to avoid intubation, or to assist in evacuation of tracheal intubation, perform ECMO adjuvant therapy;.
    • Perioperative ECMO support for elective surgeries such as high-risk or complex tracheobronchial surgeries and high-risk or complex pneumonectomies; 6). Patients judged by the investigator to be eligible for this study, such as thoracic surgery patients with high perioperative risk and prophylactic use of ECMO for perioperative safety.

Exclusion criteria

Exclusion Criteria:

  1. Age \< 18 years or > 80 years.
  2. Duration of positive pressure ventilation with tracheal intubation for more than 7 days prior to admission.
  3. Combination of severe irreversible end-stage disease, such as cancer, end-stage of the hepatocirrhosis, etc.
  4. Irreversible multiorgan failure.
  5. Combined cerebrovascular events such as severe cognitive impairment, cerebral haemorrhage or stroke occurring within 3 months.
  6. Severe coagulopathies or bleeding disorders, or the presence of contraindications to anticoagulation, or inability to administer systemic anticoagulation.
  7. Patients who are pregnant or breastfeeding.
  8. Severe peripheral vascular disease or difficulty with ECMO placement.
  9. With other untreatable end-stage disease.
  10. Other inappropriate conditions for this study in the opinion of investigators
05

Study design

Observational model
Cohort
Time perspective
Other
Enrollment
400 participants (estimated)
Patient registry
No

Interventions

  • OtherNo intervention

    This was an observational cohort study with no intervention for all enrolled patients.

06

What researchers measure

Primary outcomes

  1. 30-day mortality

    Time frame: 30 days

Secondary outcomes

  1. Duration of mechanical ventilation

    Time frame: From the onset of endotracheal intubation to the withdrawal of endotracheal intubation or death，an average of 5 weeks.

  2. ECMO duration

    Time frame: From the onset of ECMO to the withdrawal of ECMO or death, an average of 4 weeks.

  3. Length of stay in ICU

    Time frame: From ICU admission to ICU discharge or death, an average of 8 weeks.

  4. Systemic and localized bleeding

    Time frame: From ICU admission to discharge or death, , an average of 8 weeks.

  5. Ventilator-associated pneumonia

    Time frame: From ECMO run to 48 hours after ECMO withdrawal, an average of 6 weeks.

  6. Catheter-related bloodstream infection

    Time frame: From ECMO run to 48 hours after ECMO withdrawal, an average of 4 weeks.

  7. ECMO-related thrombosis

    Time frame: From the onset of ECMO to one week after the withdrawal of ECMO or death, an average of 4 weeks.

07

Study locations

1 of 1 sites recruiting
  • China-Japan Friendship hospital
    Beijing, Beijing 100028, China
    • Chen Wang, MD · Contact
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 30, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06231446
Lead sponsor
China-Japan Friendship Hospital
Responsible party
Qingyuan Zhan (prof., China-Japan Friendship Hospital) — Principal investigator
First posted
Jan 30, 2024
Start date
Oct 20, 2022
Primary completion
Dec 2024 (estimated)
Completion
Dec 2024 (estimated)
Last update
Jan 30, 2024

Study contacts

Zhijiang Qi, Dr
Contact
thymcglqi@163.com
+8618801283217

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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