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

NCT ID: NCT04842344

Last Updated: 2021-04-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 176 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-01
• Study Completion Date: 2024-03-31

Brief 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.

Conditions

Lung Diseases, Obstructive

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Noninvasive ventilation and ECCO2R

Group Type: EXPERIMENTAL

ECCO2R

Intervention Type: DEVICE

extracorporeal carbon dioxide removal

Noninvasive ventilation

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

ECCO2R

extracorporeal carbon dioxide removal

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Li Xuyan

OTHER

Sponsor Role: lead

Responsible Party

Li Xuyan

Sponsor Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Bing Sun, MD

Role: PRINCIPAL_INVESTIGATOR

Beijing Chao Yang Hospital

Locations

Beijing Institute of Respiratory Medicine, Beijing Chao-yang Hospital, Capital Medical University

Beijing, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Xuyan Li, MD

Role: CONTACT

araklee@163.com

86013581851048

Bing Sun, MD

Role: CONTACT

ricusunbing@126.com

86013911151075

Facility Contacts

Xuyan Li

Role: primary

araklee@163.com

+8613581851048

Other Identifiers

2020-KE-492

Identifier Type: -

Identifier Source: org_study_id