Extracorporeal Carbon Dioxide Removal in Severe Chronic Obstructive Pulmonary Disease Exacerbation

COPD Exacerbation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03692117
• Other study ID #: 2016YFC1304304-4
• Status: Recruiting
• Start date: January 2017
• Est. completion date: December 2020

Study information

• Verified date: January 2020
• Source: China-Japan Friendship Hospital
• Contact: Min Li, Master
• Phone: 13683598417
• Email: qlyy_limin[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• COPD Exacerbation
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Device:
• Extracorporeal Carbon Dioxide Removal
Place a double lumen catheter in jugular vein, drainage the venous blood in vitro tube, after blood-gas exchange and remove CO2, then return back to the Superior vena cava

Locations

Country	Name	City	State
China	China-Japan Friendship hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
China-Japan Friendship Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence of avoid endotracheal intubation	avoid endotracheal intubation and Invasive mechanical ventilation	30days