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

Sponsor

Li Xuyan (Other)

Overall Status

Recruiting

CT.gov ID

NCT04842344

Collaborator

(none)

176

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Lung Diseases, Obstructive	Device: ECCO2R	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

176 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

May 1, 2021

Anticipated Primary Completion Date :

Mar 31, 2024

Anticipated Study Completion Date :

Mar 31, 2024

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Noninvasive ventilation and ECCO2R

Device: ECCO2R

extracorporeal carbon dioxide removal

No Intervention: Noninvasive ventilation

Outcome Measures

Primary Outcome Measures

Demand rate of endotracheal intubation [28 days]

Secondary Outcome Measures

Actual rate of endotracheal intubation [28 days]
hospital mortality [28 days]
length of ICU stay [28 days]
length of hospital stay [28 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.