Extracorporeal Membrane Oxygenation for Respiratory Failure Patients

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

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.

Study Overview

• Status: Recruiting
• Conditions: Respiratory Failure Patients Treated With ECMO
• Intervention / Treatment: Other: No intervention

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.

• Study Type: Observational
• Enrollment (Estimated): 400

Contacts and Locations

• Study Contact: Name: Zhijiang Qi, Dr; Phone Number: +8618801283217; Email: thymcglqi@163.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100028
      • Recruiting
      • China-Japan Friendship Hospital
      • Contact: Chen Wang, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• 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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
30-day mortality	30 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Duration of mechanical ventilation	From the onset of endotracheal intubation to the withdrawal of endotracheal intubation or death，an average of 5 weeks.
ECMO duration	From the onset of ECMO to the withdrawal of ECMO or death, an average of 4 weeks.
Length of stay in ICU	From ICU admission to ICU discharge or death, an average of 8 weeks.
Systemic and localized bleeding	From ICU admission to discharge or death, , an average of 8 weeks.
Ventilator-associated pneumonia	From ECMO run to 48 hours after ECMO withdrawal, an average of 6 weeks.
Catheter-related bloodstream infection	From ECMO run to 48 hours after ECMO withdrawal, an average of 4 weeks.
ECMO-related thrombosis	From the onset of ECMO to one week after the withdrawal of ECMO or death, an average of 4 weeks.

Collaborators and Investigators

• Sponsor: China-Japan Friendship Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 20, 2022
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: January 18, 2024
• First Submitted That Met QC Criteria: January 28, 2024
• First Posted (Actual): January 30, 2024

Study Record Updates

• Last Update Posted (Actual): January 30, 2024
• Last Update Submitted That Met QC Criteria: January 28, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency
• Other Study ID Numbers: 2022-KY-113-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No