Clinical trial NCT03692117: Extracorporeal Carbon Dioxide Removal in Severe Chronic Obstructive Pulmonary Disease Exacerbation
Official title: Evaluation of Clinical Effectiveness of ECCO2R for the Treatment of Patients With Severe Acute Exacerbation of Chronic Obstructive Pulmonary Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COPD Exacerbation
Keywords: COPD Exacerbation
Severe
ECCO2R
invasive mechanical ventilation
Lead sponsor: China-Japan Friendship Hospital
Sponsor class: OTHER
First posted: 2018-10-02
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

Eligibility criteria: 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

Primary outcomes:
measure: incidence of avoid endotracheal intubation
timeFrame: 30days
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: China-Japan Friendship hospital
state: Beijing
Study officials:
affiliation: China-Japan Friendship Hospital
name: Qingyuan Zhan, M.D.
role: PRINCIPAL_INVESTIGATOR
References: