NCT04842344

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
176

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 8, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 13, 2021

Completed
18 days until next milestone

Study Start

First participant enrolled

May 1, 2021

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2024

Completed
Last Updated

April 13, 2021

Status Verified

April 1, 2021

Enrollment Period

2.9 years

First QC Date

April 8, 2021

Last Update Submit

April 10, 2021

Conditions

Lung Diseases, Obstructive

Keywords

Acute exacerbation of chronic obstructive pulmonary diseaseextracorporeal carbon dioxide removalHypercapnia respiratory failure

Outcome Measures

Primary Outcomes (1)

  • Demand rate of endotracheal intubation

    28 days

Secondary Outcomes (4)

  • Actual rate of endotracheal intubation

    28 days

  • hospital mortality

    28 days

  • length of ICU stay

    28 days

  • length of hospital stay

    28 days

Study Arms (2)

Noninvasive ventilation and ECCO2R

EXPERIMENTAL
Device: ECCO2R

Noninvasive ventilation

NO INTERVENTION

Interventions

ECCO2RDEVICE

extracorporeal carbon dioxide removal

Noninvasive ventilation and ECCO2R

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Beijing, 100020, China

RECRUITING

MeSH Terms

Conditions

Lung Diseases, Obstructive

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract Diseases

Study Officials

  • Bing Sun, MD

    Beijing Chao Yang Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Xuyan Li, MD

CONTACT

86013581851048araklee@163.com

Bing Sun, MD

CONTACT

86013911151075ricusunbing@126.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Sponsor Investigator

Study Record Dates

First Submitted

April 8, 2021

First Posted

April 13, 2021

Study Start

May 1, 2021

Primary Completion

March 31, 2024

Study Completion

March 31, 2024

Last Updated

April 13, 2021

Record last verified: 2021-04

Locations

CN(1)