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

Primary Purpose

Lung Diseases, Obstructive

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
ECCO2R
Sponsored by
Li Xuyan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Diseases, Obstructive focused on measuring Acute exacerbation of chronic obstructive pulmonary disease, extracorporeal carbon dioxide removal, Hypercapnia respiratory failure

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Noninvasive ventilation and ECCO2R

Noninvasive ventilation

Arm Description

Outcomes

Primary Outcome Measures

Demand rate of endotracheal intubation

Secondary Outcome Measures

Actual rate of endotracheal intubation
hospital mortality
length of ICU stay
length of hospital stay

Full Information

First Posted
April 8, 2021
Last Updated
April 10, 2021
Sponsor
Li Xuyan
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1. Study Identification

Unique Protocol Identification Number
NCT04842344
Brief Title
ECCO2R in the Treatment of Acute Exacerbation of COPD With Severe Hypercapnia
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2021 (Anticipated)
Primary Completion Date
March 31, 2024 (Anticipated)
Study Completion Date
March 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Li Xuyan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Diseases, Obstructive
Keywords
Acute exacerbation of chronic obstructive pulmonary disease, extracorporeal carbon dioxide removal, Hypercapnia respiratory failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
176 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Noninvasive ventilation and ECCO2R
Arm Type
Experimental
Arm Title
Noninvasive ventilation
Arm Type
No Intervention
Intervention Type
Device
Intervention Name(s)
ECCO2R
Intervention Description
extracorporeal carbon dioxide removal
Primary Outcome Measure Information:
Title
Demand rate of endotracheal intubation
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Actual rate of endotracheal intubation
Time Frame
28 days
Title
hospital mortality
Time Frame
28 days
Title
length of ICU stay
Time Frame
28 days
Title
length of hospital stay
Time Frame
28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xuyan Li, MD
Phone
86013581851048
Email
araklee@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Bing Sun, MD
Phone
86013911151075
Email
ricusunbing@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bing Sun, MD
Organizational Affiliation
Beijing Chao Yang Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Institute of Respiratory Medicine, Beijing Chao-yang Hospital, Capital Medical University
City
Beijing
ZIP/Postal Code
100020
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xuyan Li
Phone
+8613581851048
Email
araklee@163.com

12. IPD Sharing Statement

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

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