Lung Diseases, ObstructiveNCT04842344
ECCO2R in the Treatment of Acute Exacerbation of COPD With Severe Hypercapnia
A study testing ECCO2R in people with Lung Diseases, Obstructive, run by Li Xuyan at 1 site in China.
Trial summary
Patients with moderate to severe acute exacerbation of chronic obstructive pulmonary disease are often complicated with hypercapnia and respiratory failure, so they need to be admitted to ICU for monitoring and respiratory support treatment. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Lung Diseases, Obstructive
- What is being tested?
- ECCO2R
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 176 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2021to 31 Mar 2024
- Phase
- Interventional
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- AECOPD patients.
- The patients with hypercapnia respiratory failure were admitted to ICU and needed noninvasive ventilation.
- The results of blood gas analysis showed pH <7.30, PaCO2> 50 mmHg.
- There were high risk factors for failure of noninvasive ventilation: after receiving continuous 2 hours of noninvasive ventilation, the arterial blood pressure showed the pH value was ≤ 7.30, while PaCO2 was 20% higher than the baseline value, and any one or more of the following conditions were combined: respiratory rate ≥ 30 times / min, assisted respiratory muscle breathing; contradictory breathing.
- Informed consents were sighed.
Who cannot join
- The mean arterial pressure was less than 60 mmHg after volume and vasoactive drug treatment.
- There were anticoagulant contraindications.
- Weight over 120kg.
- Patients with malignant tumor or other complications, the expected survival time was less than 30 days.
- It could not cooperate with noninvasive ventilation or has contraindication of noninvasive ventilation.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Institute of Respiratory Medicine, Beijing Chao-yang Hospital, Capital Medical University
Beijing, 100020
Xuyan Li, +8613581851048, araklee@163.com
About this study
Official title: A Prospective Randomized Controlled Trial of Extracorporeal Carbon Dioxide Removal (ECCO2R) in the Treatment of Acute Exacerbation of Chronic Obstructive Pulmonary Disease With Severe Hypercapnia
Patients with moderate to severe acute exacerbation of chronic obstructive pulmonary disease are often complicated with hypercapnia and respiratory failure, so they need to be admitted to ICU for monitoring and respiratory support treatment. Noninvasive ventilation has become the first-line respiratory support for the treatment of AECOPD with hypercapnia and respiratory failure. However, 26-54% of AECOPD patients with hypercapnia and respiratory failure eventually fail to receive noninvasive ventilation and need endotracheal intubation and invasive ventilation to maintain effective gas exchange. For these patients, the in-hospital survival rate is only 31-76%, and the prognosis is poor. In AECOPD patients with high risk of noninvasive ventilation failure and expected need of intubation, timely giving other ways of respiratory support to reduce blood CO2 may avoid patients receiving tracheal intubation and invasive ventilation, thus avoiding related complications and adverse prognosis. As a new type of respiratory support technology, ECCO2R is worthy of attention in monitoring and evaluation of support effect in AECOPD patients with respiratory failure. It is urgent that ECCO2R can effectively alleviate respiratory failure, avoid complications related to tracheal intubation, improve quality of life and reduce mortality.
- Conditions
- Lung Diseases, Obstructive
- Being tested
- ECCO2R
- Keywords
- Acute exacerbation of chronic obstructive pulmonary disease, extracorporeal carbon dioxide removal, Hypercapnia respiratory failure
- Medical subject headings
- Lung Diseases, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ECCO2RDevice
extracorporeal carbon dioxide removal
| Study group | Role | What they receive |
|---|---|---|
| Noninvasive ventilation and ECCO2R | Experimental | Not described Receives: Device: ECCO2R |
| Noninvasive ventilation | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demand rate of endotracheal intubation
Measured: 28 days
Secondary outcomes (4)
Actual rate of endotracheal intubation
Measured: 28 days
hospital mortality
Measured: 28 days
length of ICU stay
Measured: 28 days
length of hospital stay
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2021
- Study start1 May 2021 (estimated)
- Primary completion31 Mar 2024 (estimated)
- Study completion31 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Diseases, ObstructiveStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 176 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Li Xuyan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Li Xuyan, Beijing Chao Yang Hospital
- Investigators
- Bing Sun, MD, Principal investigator, Beijing Chao Yang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04842344
- Sponsor's protocol ID
- 2020-KE-492
- Status last verified
- Apr 2021
- First submitted
- 8 Apr 2021
- Last updated
- 13 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Controlled Trial of Extracorporeal Carbon Dioxide Removal (ECCO2R) in the Treatment of Acute Exacerbation of Chronic Obstructive Pulmonary Disease With Severe Hypercapnia
- ClinicalTrials.gov ID
- NCT04842344
- Acronym / sponsor ID
- 2020-KE-492
- Conditions
- Lung Diseases, Obstructive
- Keywords
- Acute exacerbation of chronic obstructive pulmonary disease, extracorporeal carbon dioxide removal, Hypercapnia respiratory failure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 176 participants (estimated)
- Lead sponsor
- Li XuyanUniversity, hospital or other
- Study start
- 1 May 2021 (estimated)
- Primary completion
- 31 Mar 2024 (estimated)
- Study completion
- 31 Mar 2024 (estimated)
- First posted
- 13 Apr 2021 (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.
Patients with moderate to severe acute exacerbation of chronic obstructive pulmonary disease are often complicated with hypercapnia and respiratory failure, so they need to be admitted to ICU for monitoring and respiratory support treatment. Noninvasive ventilation has become the first-line respiratory support for the treatment of AECOPD with hypercapnia and respiratory failure. However, 26-54% of AECOPD patients with hypercapnia and respiratory failure eventually fail to receive noninvasive ventilation and need endotracheal intubation and invasive ventilation to maintain effective gas exchange. For these patients, the in-hospital survival rate is only 31-76%, and the prognosis is poor. In AECOPD patients with high risk of noninvasive ventilation failure and expected need of intubation, timely giving other ways of respiratory support to reduce blood CO2 may avoid patients receiving tracheal intubation and invasive ventilation, thus avoiding related complications and adverse prognosis. As a new type of respiratory support technology, ECCO2R is worthy of attention in monitoring and evaluation of support effect in AECOPD patients with respiratory failure. It is urgent that ECCO2R can effectively alleviate respiratory failure, avoid complications related to tracheal intubation, improve quality of life and reduce mortality.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Noninvasive ventilation and ECCO2R | Experimental | Device: ECCO2R |
| Noninvasive ventilation | No intervention | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- AECOPD patients.
- The patients with hypercapnia respiratory failure were admitted to ICU and needed noninvasive ventilation.
- The results of blood gas analysis showed pH <7.30, PaCO2> 50 mmHg.
- There were high risk factors for failure of noninvasive ventilation: after receiving continuous 2 hours of noninvasive ventilation, the arterial blood pressure showed the pH value was ≤ 7.30, while PaCO2 was 20% higher than the baseline value, and any one or more of the following conditions were combined: respiratory rate ≥ 30 times / min, assisted respiratory muscle breathing; contradictory breathing.
- Informed consents were sighed.
Key exclusion criteria (5 listed)
- The mean arterial pressure was less than 60 mmHg after volume and vasoactive drug treatment.
- There were anticoagulant contraindications.
- Weight over 120kg.
- Patients with malignant tumor or other complications, the expected survival time was less than 30 days.
- It could not cooperate with noninvasive ventilation or has contraindication of noninvasive ventilation.
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 |
|---|---|---|
| ECCO2Rextracorporeal carbon dioxide removal | Device | Noninvasive ventilation and ECCO2R |
Primary outcome
Demand rate of endotracheal intubation
Time frame: 28 days
4 secondary outcomes
Actual rate of endotracheal intubation
Time frame: 28 days
hospital mortality
Time frame: 28 days
length of ICU stay
Time frame: 28 days
length of hospital stay
Time frame: 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2021.
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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.
Bing Sun, MD principal investigator
Beijing Chao Yang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ECCO2R in people with Lung Diseases, Obstructive, run by Li Xuyan 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 5 inclusion and 5 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 13 Apr 2021. 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 Xuyan Li, MD (86013581851048, araklee@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Demand rate of endotracheal intubation (time frame: 28 days). 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 13 Apr 2021.