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Clinical Trials/NCT03692117
NCT03692117
Unknown
Not Applicable

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

China-Japan Friendship Hospital1 site in 1 country30 target enrollmentJanuary 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
COPD Exacerbation
Sponsor
China-Japan Friendship Hospital
Enrollment
30
Locations
1
Primary Endpoint
incidence of avoid endotracheal intubation
Last Updated
6 years ago

Overview

Brief Summary

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.

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.

Registry
clinicaltrials.gov
Start Date
January 2017
End Date
December 2020
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
China-Japan Friendship Hospital
Responsible Party
Principal Investigator
Principal Investigator

Qingyuan Zhan

head of Pulmonary and Critical care medicine ward 4

China-Japan Friendship Hospital

Eligibility Criteria

Inclusion Criteria

  • NPPV treatment failure:
  • deterioration or no improvement after treatment with NPPV, pH \< 7.25, PaCO2 \> 70mmHg
  • Obvious respiratory distress, RR \> 30 times/min
  • 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

Outcomes

Primary Outcomes

incidence of avoid endotracheal intubation

Time Frame: 30days

avoid endotracheal intubation and Invasive mechanical ventilation

Study Sites (1)

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