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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Lung Diseases, Obstructive
• Intervention / Treatment: Device: ECCO2R

• Study Type: Interventional
• Enrollment (Anticipated): 176
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Bing Sun, MD; Phone Number: 86013911151075; Email: ricusunbing@126.com
• Study Contact Backup: Name: Xuyan Li, MD; Phone Number: 86013581851048; Email: araklee@163.com

Study Locations

• China
  • Beijing, China, 100020
    • Recruiting
    • Beijing Institute of Respiratory Medicine, Beijing Chao-yang Hospital, Capital Medical University
    • Contact: Xuyan Li; Phone Number: +8613581851048; Email: araklee@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Noninvasive ventilation and ECCO2R	Device: ECCO2R; extracorporeal carbon dioxide removal
No Intervention: Noninvasive ventilation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Demand rate of endotracheal intubation	28 days

Secondary Outcome Measures

Outcome Measure	Time Frame
length of ICU stay	28 days
Actual rate of endotracheal intubation	28 days
hospital mortality	28 days
length of hospital stay	28 days

Collaborators and Investigators

• Sponsor: Li Xuyan

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2021
• Primary Completion (Anticipated): March 31, 2024
• Study Completion (Anticipated): March 31, 2024

Study Registration Dates

• First Submitted: April 8, 2021
• First Submitted That Met QC Criteria: April 10, 2021
• First Posted (Actual): April 13, 2021

Study Record Updates

• Last Update Posted (Actual): April 13, 2021
• Last Update Submitted That Met QC Criteria: April 10, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Acute exacerbation of chronic obstructive pulmonary disease; extracorporeal carbon dioxide removal; Hypercapnia respiratory failure
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Lung Diseases; Lung Diseases, Obstructive; Hypercapnia
• Other Study ID Numbers: 2020-KE-492

Drug and device information, study documents

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