Extracorporeal Carbon Dioxide Removal in Severe Chronic Obstructive Pulmonary Disease Exacerbation

NCT ID: NCT03692117

Last Updated: 2020-01-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-01-31

Study Completion Date

2020-12-31

Brief Summary

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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

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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.

Conditions

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COPD Exacerbation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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China-Japan Friendship Hospital

OTHER

Sponsor Role lead

Responsible Party

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Qingyuan Zhan

head of Pulmonary and Critical care medicine ward 4

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Qingyuan Zhan, M.D.

Role: PRINCIPAL_INVESTIGATOR

China-Japan Friendship Hospital

Locations

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China-Japan Friendship hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Min Li, Master

Role: CONTACT

13683598417 ext. +86

Facility Contacts

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Chen Wang, MD

Role: primary

Other Identifiers

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2016YFC1304304-4

Identifier Type: -

Identifier Source: org_study_id

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