NCT03692117

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

September 25, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 2, 2018

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

January 18, 2020

Status Verified

January 1, 2020

Enrollment Period

3.9 years

First QC Date

September 25, 2018

Last Update Submit

January 13, 2020

Conditions

Keywords

COPD ExacerbationSevereECCO2Rinvasive mechanical ventilation

Outcome Measures

Primary Outcomes (1)

  • incidence of avoid endotracheal intubation

    avoid endotracheal intubation and Invasive mechanical ventilation

    30days

Interventions

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

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

China-Japan Friendship hospital

Beijing, Beijing Municipality, 100028, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, Follicular

Condition Hierarchy (Ancestors)

Lymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Qingyuan Zhan, M.D.

    China-Japan Friendship Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Min Li, Master

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
head of Pulmonary and Critical care medicine ward 4

Study Record Dates

First Submitted

September 25, 2018

First Posted

October 2, 2018

Study Start

January 1, 2017

Primary Completion

December 1, 2020

Study Completion

December 1, 2020

Last Updated

January 18, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations