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

Sponsors

Lead Sponsor: Li Xuyan

Source Beijing Chao Yang Hospital
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.

Overall Status Recruiting
Start Date 2021-05-01
Completion Date 2024-03-31
Primary Completion Date 2024-03-31
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Demand rate of endotracheal intubation 28 days
Secondary Outcome
Measure Time Frame
Actual rate of endotracheal intubation 28 days
hospital mortality 28 days
length of ICU stay 28 days
length of hospital stay 28 days
Enrollment 176
Condition
Intervention

Intervention Type: Device

Intervention Name: ECCO2R

Description: extracorporeal carbon dioxide removal

Arm Group Label: Noninvasive ventilation and ECCO2R

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.

Gender:

All

Minimum Age:

18 Years

Maximum Age:

80 Years

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Bing Sun, MD Principal Investigator Beijing Chao Yang Hospital
Overall Contact

Last Name: Xuyan Li, MD

Phone: 86013581851048

Email: [email protected]

Location
Facility: Status: Contact: Beijing Institute of Respiratory Medicine, Beijing Chao-yang Hospital, Capital Medical University Xuyan Li +8613581851048 [email protected]
Location Countries

China

Verification Date

2021-04-01

Responsible Party

Type: Sponsor-Investigator

Investigator Affiliation: Beijing Chao Yang Hospital

Investigator Full Name: Li Xuyan

Investigator Title: Sponsor Investigator

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Noninvasive ventilation and ECCO2R

Type: Experimental

Label: Noninvasive ventilation

Type: No Intervention

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

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