ECCO2R in the Treatment of Acute Exacerbation of COPD With Severe Hypercapnia

Lung Diseases, Obstructive Clinical Trial

Official title:

A Prospective Randomized Controlled Trial of Extracorporeal Carbon Dioxide Removal (ECCO2R) in the Treatment of Acute Exacerbation of Chronic Obstructive Pulmonary Disease With Severe Hypercapnia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04842344
• Other study ID #: 2020-KE-492
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2021
• Est. completion date: March 31, 2024

Study information

• Verified date: April 2021
• Source: Beijing Chao Yang Hospital
• Contact: Xuyan Li, MD
• Phone: 86013581851048
• Email: araklee[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Patients with moderate to severe acute exacerbation of chronic obstructive pulmonary disease are often complicated with hypercapnia and respiratory failure, so they need to be admitted to ICU for monitoring and respiratory support treatment. Noninvasive ventilation has become the first-line respiratory support for the treatment of AECOPD with hypercapnia and respiratory failure. However, 26-54% of AECOPD patients with hypercapnia and respiratory failure eventually fail to receive noninvasive ventilation and need endotracheal intubation and invasive ventilation to maintain effective gas exchange. For these patients, the in-hospital survival rate is only 31-76%, and the prognosis is poor. In AECOPD patients with high risk of noninvasive ventilation failure and expected need of intubation, timely giving other ways of respiratory support to reduce blood CO2 may avoid patients receiving tracheal intubation and invasive ventilation, thus avoiding related complications and adverse prognosis. As a new type of respiratory support technology, ECCO2R is worthy of attention in monitoring and evaluation of support effect in AECOPD patients with respiratory failure. It is urgent that ECCO2R can effectively alleviate respiratory failure, avoid complications related to tracheal intubation, improve quality of life and reduce mortality.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 176
• Est. completion date: March 31, 2024
• Est. primary completion date: March 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• AECOPD patients.

• The patients with hypercapnia respiratory failure were admitted to ICU and needed noninvasive ventilation.

• The results of blood gas analysis showed pH <7.30, PaCO2> 50 mmHg.

• There were high risk factors for failure of noninvasive ventilation: after receiving continuous 2 hours of noninvasive ventilation, the arterial blood pressure showed the pH value was = 7.30, while PaCO2 was 20% higher than the baseline value, and any one or more of the following conditions were combined: respiratory rate = 30 times / min, assisted respiratory muscle breathing; contradictory breathing.

• Informed consents were sighed.

Exclusion Criteria:

• The mean arterial pressure was less than 60 mmHg after volume and vasoactive drug treatment.

• There were anticoagulant contraindications.

• Weight over 120kg.

• Patients with malignant tumor or other complications, the expected survival time was less than 30 days.

• It could not cooperate with noninvasive ventilation or has contraindication of noninvasive ventilation.

Related Conditions & MeSH terms

• Hypercapnia
• Lung Diseases
• Lung Diseases, Obstructive

Intervention

Device:
• ECCO2R
extracorporeal carbon dioxide removal

Locations

Country	Name	City	State
China	Beijing Institute of Respiratory Medicine, Beijing Chao-yang Hospital, Capital Medical University	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Li Xuyan

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Demand rate of endotracheal intubation		28 days
Secondary	Actual rate of endotracheal intubation		28 days
Secondary	hospital mortality		28 days
Secondary	length of ICU stay		28 days
Secondary	length of hospital stay		28 days