Observing respiratory failure patients treated with ECMO

A Multicenter Prospective Cohort Study of the Clinical Characteristics and Prognosis of Respiratory Failure Patients With ECMO Therapy

This study looks at patients with severe breathing problems who are treated with a special machine called ECMO to see how they do and find ways to improve their care.

Quick facts

• Study type: Observational
• Enrollment: 400 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: China-Japan Friendship Hospital (other)
• Locations: 1 site (Beijing, Beijing)
• Trial ID: NCT06231446 on ClinicalTrials.gov

What this trial studies

This multicentre cohort study focuses on patients with respiratory failure who are treated using extracorporeal membrane oxygenation (ECMO). It collects clinical data both retrospectively and prospectively to analyze the characteristics and prognosis of these patients in China. The study aims to address the lack of real-world clinical data on ECMO, identify risk factors for major complications, and explore new biomarkers for better management of ECMO therapy. By establishing a clinical database and biospecimen library, the study seeks to improve ECMO quality management and patient outcomes.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 to 80 with severe respiratory failure requiring ECMO support.

Not a fit: Patients with contraindications to ECMO or those outside the specified age range may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance the understanding and management of ECMO therapy for respiratory failure, potentially leading to improved patient outcomes.

How similar studies have performed: While ECMO has been widely studied internationally, this specific observational approach in the context of China is relatively novel and aims to fill existing gaps in local clinical data.

Eligibility criteria

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:

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

Where this trial is running

Beijing, Beijing

• China-Japan Friendship hospital — Beijing, Beijing, China (RECRUITING)

Study contacts

• Study coordinator: Zhijiang Qi, Dr

Conditions: Respiratory Failure Patients Treated With ECMO