COPD ExacerbationNCT03692117
Extracorporeal Carbon Dioxide Removal in Severe Chronic Obstructive Pulmonary Disease Exacerbation
An observational study of COPD Exacerbation, run by China-Japan Friendship Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- COPD Exacerbation
- What is being tested?
- Extracorporeal Carbon Dioxide Removal
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- Jan 2017to Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
China-Japan Friendship hospital
Beijing, Beijing Municipality, 100028
Chen Wang, MD
About this study
Official title: Evaluation of Clinical Effectiveness of ECCO2R for the Treatment of Patients With Severe Acute Exacerbation of Chronic Obstructive Pulmonary Disease
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.
Read the 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.
- Conditions
- COPD Exacerbation
- Being tested
- Extracorporeal Carbon Dioxide Removal
- Keywords
- COPD Exacerbation, Severe, ECCO2R, invasive mechanical ventilation
- Medical subject headings
- Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extracorporeal Carbon Dioxide RemovalDevice
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
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of avoid endotracheal intubation
avoid endotracheal intubation and Invasive mechanical ventilation
Measured: 30days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2018
- Study startJan 2017
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPD ExacerbationStudies of the same condition, open and under way.
- More trials run by China-Japan Friendship HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China-Japan Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qingyuan Zhan, China-Japan Friendship Hospital
- Investigators
- Qingyuan Zhan, M.D., Principal investigator, China-Japan Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03692117
- Sponsor's protocol ID
- 2016YFC1304304-4
- Status last verified
- Jan 2020
- First submitted
- 25 Sep 2018
- Last updated
- 18 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Clinical Effectiveness of ECCO2R for the Treatment of Patients With Severe Acute Exacerbation of Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT03692117
- Acronym / sponsor ID
- 2016YFC1304304-4
- Conditions
- COPD Exacerbation
- Keywords
- COPD Exacerbation, Severe, ECCO2R, invasive mechanical ventilation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- China-Japan Friendship HospitalUniversity, hospital or other
- Study start
- Jan 2017
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 2 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- NPPV treatment failure:
Key exclusion criteria (16 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Extracorporeal Carbon Dioxide RemovalPlace 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 | Device | – |
Primary outcome
incidence of avoid endotracheal intubation
Time frame: 30days
avoid endotracheal intubation and Invasive mechanical ventilation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2020.
- Individual participant dataSharing planned: No
Related trials for COPD Exacerbation
Active, not recruiting
Influence of FreeO2 on Percentage of Time Within Oxygen Saturation Target Using Noninvasive Ventilation (NIV) and Continuous Positive Airway Pressure (CPAP) for Patients Admitted for AECOPD or Bariatric Surgery
COPD Exacerbation, Oxygen Toxicity
Active, not recruiting
FreeDom: Innovative Strategy for the Management of COPD Exacerbations
Oxygen Deficiency, COPD Exacerbation
RecruitingPhase 2
Rademikibart IV for Acute Asthma and COPD Exacerbation
Asthma Acute, COPD Exacerbation Acute
Not yet recruitingPhase 1
Investigating Senolytic Properties in Pulmonary Rehabilitation and Metformin in COPD Exacerbations
Chronic Obstructive Pulmonary Disease (COPD)
RecruitingObservational study
Swiss Chronic Obstructive Pulmonary Disease (COPD) Management Cohort
Chronic Obstructive Pulmonary Disease, COPD Exacerbation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Qingyuan Zhan, M.D. principal investigator
China-Japan Friendship Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COPD Exacerbation, run by China-Japan Friendship Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Min Li, Master (13683598417 ext. +86, qlyy_limin@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of avoid endotracheal intubation (time frame: 30days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2020.