Extracorporeal Carbon Dioxide Removal in Severe Chronic Obstructive Pulmonary Disease Exacerbation

January 13, 2020 updated by: Qingyuan Zhan, China-Japan Friendship Hospital

Evaluation of Clinical Effectiveness of ECCO2R for the Treatment of Patients With Severe Acute Exacerbation of Chronic Obstructive Pulmonary Disease

The conventional treatment for Severe acute exacerbation of Chronic obstructive pulmonary disease including noninvasive respiratory support, invasive respiratory support, etc, but there are many kinds of limitations and complications. Extracorporeal Carbon Dioxide Removal is a life support technology, which can effectively remove CO2. Recently some clinical studies have showed that ECCO2R can effectively improve the AECOPD patient's respiratory failure, avoid intubation and removal of endotracheal intubation. We performed a study to evaluate the clinical effectiveness of ECCO2R in the treatment of AECOPD patients.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

With the development of technology, ECCO2R is not difficult to implement in intensive care unit. Many recently clinical studies have showed that ECCO2R can effectively remove CO2, reduce patient breathing work, improve the patient respiratory failure, and avoid endotracheal intubation. But there are also treated failure and high incidence of complications such as bleeding in the AECOPD patients with ECCO2R treatment, and the treatment related to airway management are less mentioned. Therefore, we set a more strict inclusion criteria in AECOPD patients and evaluate the clinical effectiveness and associated risk of ECCO2R in the treatment of AECOPD.

Study Type

Observational

Enrollment (Anticipated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100028
        • Recruiting
        • China-Japan Friendship Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The patients with AECOPD accept the NPPV treatment, deterioration or no improvement of Clinical status. we expected them to be avoided endotracheal intubation after treatment with ECCO2R

Description

Inclusion Criteria:

  • NPPV treatment failure:

    1. deterioration or no improvement after treatment with NPPV, pH < 7.25, PaCO2 > 70mmHg
    2. Obvious respiratory distress, RR > 30 times/min
    3. Breathing extreme fatigue

Exclusion Criteria:

  • Older than 75 years
  • endotracheal intubation or tracheostomy
  • obviously a lot of pus yellow phlegm, expectorate difficult
  • Chest CT: obviously a wide range of consolidation
  • BMI < 20 kg/m2,
  • Dysfunction of other organ of extrapulmonary
  • serious hemodynamic instability
  • severe hypoxemia, PaO2 / FiO2 < 100mmHg
  • home noninvasive positive pressure ventilation for a long time
  • lung fungal infection
  • contraindication of anticoagulation
  • Platelet < 80000 per cubic millimeter
  • Serum creatinine > 200 umol/L
  • cardiac arrest
  • Hospice care
  • Refused to take part in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
incidence of avoid endotracheal intubation
Time Frame: 30days
avoid endotracheal intubation and Invasive mechanical ventilation
30days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

China-Japan Friendship Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2017

Primary Completion (Anticipated)

December 1, 2020

Study Completion (Anticipated)

December 1, 2020

Study Registration Dates

First Submitted

September 25, 2018

First Submitted That Met QC Criteria

September 28, 2018

First Posted (Actual)

October 2, 2018

Study Record Updates

Last Update Posted (Actual)

January 18, 2020

Last Update Submitted That Met QC Criteria

January 13, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016YFC1304304-4

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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