Extracorporeal Membrane Oxygenation for Respiratory Failure Patients

NCT06231446 | Unknown

• 1 other identifier: 2022-KY-113-1
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Respiratory Failure Patients Treated With ECMO

Outcome Measures

Primary Outcomes (1)

• 30-day mortality

  30 days

Secondary Outcomes (7)

• 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.

Interventions

No intervention OTHER

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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• China-Japan Friendship Hospital: lead

Study Sites (1)

China-Japan Friendship hospital

Beijing, Beijing Municipality, 100028, China

RECRUITING

Central Study Contacts

Zhijiang Qi, Dr

CONTACT

+8618801283217; thymcglqi@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: prof.

Study Record Dates

• First Submitted: January 18, 2024
• First Posted: January 30, 2024
• Study Start: October 20, 2022
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: January 30, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)