Extracorporeal Carbon Dioxide Removal in Severe Chronic Obstructive Pulmonary Disease Exacerbation

Sponsor:

Collaborators:

Information provided by (Responsible Party):

Qingyuan Zhan，China-Japan Friendship Hospital

Tracking Information

First Submitted Date ^ICMJE

September 25, 2018

First Posted Date ^ICMJE

October 2, 2018

Last Update Posted Date

October 2, 2018

Actual Study Start Date ^ICMJE

January 2017

Estimated Primary Completion Date

December 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

incidence of avoid endotracheal intubation[ Time Frame: 30days ]

avoid endotracheal intubation and Invasive mechanical ventilation

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

[ Time Frame: ]

Descriptive Information

Brief Title ^ICMJE

Extracorporeal Carbon Dioxide Removal in Severe Chronic Obstructive Pulmonary Disease Exacerbation

Official Title ^ICMJE

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

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.

Study Type ^ICMJE

Observational

Study Phase

Study Design ^ICMJE

Allocation:
Intervention Model:
Intervention Model Description:
Masking: Observational
Masking Description:
Primary Purpose:

Condition ^ICMJE

Intervention ^ICMJE

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

Study Arms

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

December 2020

Estimated Primary Completion Date

December 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

China

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product:
Studies a U.S. FDA-regulated Device Product:

IPD Sharing Statement

Plan to Share IPD:

Responsible Party

Qingyuan Zhan，China-Japan Friendship Hospital

Study Sponsor ^ICMJE

China-Japan Friendship Hospital

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator: Qingyuan Zhan, M.D. China-Japan Friendship Hospital

PRS Account

China-Japan Friendship Hospital

Verification Date

September 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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