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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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04842344
Enrollment
176
Registered
2021-04-13
Start date
2021-05-01
Completion date
2024-03-31
Last updated
2021-04-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Diseases, Obstructive

Keywords

Acute exacerbation of chronic obstructive pulmonary disease, extracorporeal carbon dioxide removal, Hypercapnia respiratory failure

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.

Interventions

DEVICEECCO2R

extracorporeal carbon dioxide removal

Sponsors

Li Xuyan
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Demand rate of endotracheal intubation28 days

Secondary

MeasureTime frame
Actual rate of endotracheal intubation28 days
hospital mortality28 days
length of ICU stay28 days
length of hospital stay28 days

Countries

China

Contacts

Primary ContactXuyan Li, MD
araklee@163.com86013581851048
Backup ContactBing Sun, MD
ricusunbing@126.com86013911151075

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026