Chronic Obstructive Pulmonary DiseaseNCT02086084
ECCO2R as an Adjunct to NIV in AECOPD
A study testing NIV and ECCO2R in people with Chronic Obstructive Pulmonary Disease, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Chronic obstructive pulmonary disease (COPD) is one of the UKs commonest chronic diseases and is responsible for a significant number of acute hospital admissions. COPD is characterised by progressive destruction in the elastic tissue within the lung, causing respiratory failure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- NIV and ECCO2R
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Dec 2015to 31 Dec 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Known COPD with an acute exacerbation. An acute exacerbation is defined as per the GOLD criteria as an increase in dyspnoea, cough and/or sputum over the patient's normal symptoms. A severe exacerbation is defined as one requiring hospital admission.
- Patients with a persistent arterial pH<7.30 due primarily to hypercapnic respiratory failure after standard medical therapy and at least 1 hour of NIV.
- Age over 18
Who cannot join
- Haemodynamic instability after ensuring euvolaemia
- Acute multiple organ failure requiring other organ supportive therapy, including indication for intubation and mechanical ventilation
- Known allergy/intolerance of heparin including known heparin induced thrombosis and thrombocytopaenia
- Acute uncontrolled haemorrhage
- Intracerebral haemorrhage
- Recent (<6 months) ischaemic cerebrovascular accident
Show all 23Show fewer
- Organ transplant recipient
- Expected to die within 24 hours
- Venous abnormality or body habitus precluding cannulation
- Contraindication to NIV (as per British Thoracic Society recommendation)
- Facial burns/trauma/recent facial or upper airway surgery
- Vomiting
- Fixed upper airway obstruction
- Undrained pneumothorax
- Recent upper gastrointestinal surgery
- Inability to protect the airway
- Life threatening hypoxaemia (PaO2/FiO2 <20kPa)
- Bowel obstruction
- Patient refusal
- Pregnancy
- Severe hepatic failure (ascites, hepatic encephalopathy or bilirubin >100umol/L)
- Severe chronic cardiac failure (NYHA class III or IV)
- Bleeding diathesis (INR>1.5, platelets <80,000) in the absence of anticoagulation therapy
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Guy's and St Thomas' NHS Foundation Trust
London, SE1 7EH
About this study
Official title: Extra-corporeal CO2 Removal as an Adjunct to Non-Invasive Ventilation in Acute Severe Exacerbations of COPD
Chronic obstructive pulmonary disease (COPD) is one of the UKs commonest chronic diseases and is responsible for a significant number of acute hospital admissions. COPD is characterised by progressive destruction in the elastic tissue within the lung, causing respiratory failure. The clinical course of COPD is characterised by recurrent acute exacerbations (AECOPD), causing considerable morbidity and mortality. Patients with moderate to severe acute exacerbations present with increased work of breathing and hypercapnia. The standard for respiratory support in this setting is non-invasive ventilation (NIV), a management strategy underpinned by a considerable evidence base. However despite NIV, up to 30% of patients with AECOPD will 'fail' and require intubation and mechanical ventilation. The mortality rate for patients requiring NIV is approximately 4%, if conversion to mechanical ventilation occurs the mortality is 29%.
The last decade has seen an increasing interest in the provision of extracorporeal support for respiratory failure. The key element that has underpinned improving survival has been technological advancement. This has resulted in pumps causing less blood trauma and inflammatory response, better percutaneous cannulation techniques and coated circuits with reduced heparin requirements. Overall this has significantly reduced the complications associated with the provision of extracorporeal support. One variation of this technique (extra-corporeal CO2 removal ECCO2R) allows CO2 clearance from the blood. This approach has been the subject of a number of animal experiments and uncontrolled human case series demonstrating improved arterial CO2 and reduced work of breathing. Our own unpublished series demonstrates the same physiological changes. However to date the benefits of this approach have not been tested in a randomised controlled trial.
The hypothesis is that the addition of ECCO2R to NIV will shorten the duration of NIV and reduce likelihood of intubation.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- NIV, ECCO2R
- Keywords
- Acute Exacerbation Chronic Obstructive Pulmonary Disease, AECOPD, Non invasive ventilation, NIV, Extracorporeal carbon dioxide removal, ECCO2R
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NIVDevice
Standard care
ECCO2RDevice
Also called Haemolung
Application of ECCO2R in addition to NIV
| Study group | Role | What they receive |
|---|---|---|
| NIV | Active comparator | Standard application of NIV in hypercapnic respiratory failure as per usual standard of care Receives: Device: NIV |
| ECCO2R | Experimental | Addition of ECCO2R to NIV in AECOPD Receives: Device: NIV; Device: ECCO2R |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to cessation NIV
Time to cessation of NIV is defined as from NIV commencement to 6 hours without NIV.
Measured: participants will be followed for the duration of ICU stay, an expected average of 4 days
Secondary outcomes (18)
Mortality
Measured: at 90 days
Time to event analysis
This is a composite endpoint to assess the ability to complete the required elements of the study from screening to commencement of ECCO2R in a clinically relevant timeframe
Measured: initial phase of study, an expected average of 3 hours
Health-related quality of life (HRQoL)
Measured: 90 days
Cannulation-related outcomes
composite outcome of cannulation related complications
Measured: participants will be followed for the duration of ICU stay, an expected average of 4 days
haemolysis related to the intervention
Measured: participants will be followed for the duration of ICU stay, an expected average of 4 days
work of breathing
Measured: participants will be followed for the duration of ICU stay, an expected average of 4 days
Time to cessation ECCO2R
Defined as from the commencement of ECCO2R to 6 hours following cessation of CO2 removal
Measured: participants will be followed for the duration of ICU stay, an expected average of 4 days
Time to normalisation of pH
Measured: participants will be followed for the duration of ICU stay, an expected average of 4 days
Hospital Length of stay
Measured: participants will be followed for the duration of hospital stay, an expected average of 10 days
Intubation rate
Measured: participants will be followed for the duration of ICU stay, an expected average of 4 days
Incidence of tracheostomy
Measured: participants will be followed for the duration of ICU stay, an expected average of 4 days
length of ICU stay
Measured: participants will be followed for the duration of ICU stay, an expected average of 4 days
Tolerance of therapy
Measured: participants will be followed for the duration of ICU stay, an expected average of 4 days
subjective dyspnoea
Measured: participants will be followed for the duration of ICU stay, an expected average of 4 days
nutrition
total caloric intake during interventional period
Measured: participants will be followed for the duration of ICU stay, an expected average of 4 days
Mobilisation
mobilisation from bed during the study period
Measured: participants will be followed for the duration of ICU stay, an expected average of 4 days
thrombotic complications
measurement of thrombotic complications in the patient related to the device
Measured: participants will be followed for the duration of ICU stay, an expected average of 4 days
respiratory mechanics
Measured: participants will be followed for the duration of ICU stay, an expected average of 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2014 (estimated)
- Study start1 Dec 2015
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Alung Technologies
- Responsible party
- Principal investigator, Nicholas Barrett, Guy's and St Thomas' NHS Foundation Trust
- Investigators
- Nicholas Barrett, FCICM, Principal investigator, Guy's and St Thomas' NHS Foundation TrustLuigi Camporota, PhD, Principal investigator, Guy's and St Thomas' NHS Foundation TrustNicholas Hart, PhD, Principal investigator, Guy's and St Thomas' NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02086084
- Sponsor's protocol ID
- ECCO2R in AECOPD
- Status last verified
- Aug 2021
- First submitted
- 9 Mar 2014
- Last updated
- 11 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Barrett NA, Murgolo F, Grasso S, Kostakou E, Hart N, Murphy P, Douiri A, Camporota L. Physiological Assessment of ECCO2R on the Work of Breathing in Exacerbations of COPD. COPD. 2024 Dec;21(1):2436169. doi: 10.1080/15412555.2024.2436169. Epub 2024 Dec 5.
PubMed 39639560Barrett NA, Hart N, Daly KJR, Marotti M, Kostakou E, Carlin C, Lua S, Singh S, Bentley A, Douiri A, Camporota L. A randomised controlled trial of non-invasive ventilation compared with extracorporeal carbon dioxide removal for acute hypercapnic exacerbations of chronic obstructive pulmonary disease. Ann Intensive Care. 2022 Apr 21;12(1):36. doi: 10.1186/s13613-022-01006-8.
PubMed 35445986Barrett NA, Hart N, Camporota L. In vivo carbon dioxide clearance of a low-flow extracorporeal carbon dioxide removal circuit in patients with acute exacerbations of chronic obstructive pulmonary disease. Perfusion. 2020 Jul;35(5):436-441. doi: 10.1177/0267659119896531. Epub 2020 Jan 11.
PubMed 31928313Barrett NA, Kostakou E, Hart N, Douiri A, Camporota L. Extracorporeal carbon dioxide removal for acute hypercapnic exacerbations of chronic obstructive pulmonary disease: study protocol for a randomised controlled trial. Trials. 2019 Jul 30;20(1):465. doi: 10.1186/s13063-019-3548-4.
PubMed 31362776
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extra-corporeal CO2 Removal as an Adjunct to Non-Invasive Ventilation in Acute Severe Exacerbations of COPD
- ClinicalTrials.gov ID
- NCT02086084
- Acronym / sponsor ID
- ECCO2R in AECOPD
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Acute Exacerbation Chronic Obstructive Pulmonary Disease, AECOPD, Non invasive ventilation, NIV, Extracorporeal carbon dioxide removal, ECCO2R
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Guy's and St Thomas' NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Alung Technologies
- Study start
- 1 Dec 2015 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 13 Mar 2014 (estimated)
- 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.
Chronic obstructive pulmonary disease (COPD) is one of the UKs commonest chronic diseases and is responsible for a significant number of acute hospital admissions. COPD is characterised by progressive destruction in the elastic tissue within the lung, causing respiratory failure. The clinical course of COPD is characterised by recurrent acute exacerbations (AECOPD), causing considerable morbidity and mortality. Patients with moderate to severe acute exacerbations present with increased work of breathing and hypercapnia. The standard for respiratory support in this setting is non-invasive ventilation (NIV), a management strategy underpinned by a considerable evidence base. However despite NIV, up to 30% of patients with AECOPD will 'fail' and require intubation and mechanical ventilation. The mortality rate for patients requiring NIV is approximately 4%, if conversion to mechanical ventilation occurs the mortality is 29%.
The last decade has seen an increasing interest in the provision of extracorporeal support for respiratory failure. The key element that has underpinned improving survival has been technological advancement. This has resulted in pumps causing less blood trauma and inflammatory response, better percutaneous cannulation techniques and coated circuits with reduced heparin requirements. Overall this has significantly reduced the complications associated with the provision of extracorporeal support. One variation of this technique (extra-corporeal CO2 removal ECCO2R) allows CO2 clearance from the blood. This approach has been the subject of a number of animal experiments and uncontrolled human case series demonstrating improved arterial CO2 and reduced work of breathing. Our own unpublished series demonstrates the same physiological changes. However to date the benefits of this approach have not been tested in a randomised controlled trial.
The hypothesis is that the addition of ECCO2R to NIV will shorten the duration of NIV and reduce likelihood of intubation.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NIV | Active comparator | Device: NIVStandard application of NIV in hypercapnic respiratory failure as per usual standard of care |
| ECCO2R | Experimental | Device: NIV, Device: ECCO2RAddition of ECCO2R to NIV in AECOPD |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Known COPD with an acute exacerbation. An acute exacerbation is defined as per the GOLD criteria as an increase in dyspnoea, cough and/or sputum over the patient's normal symptoms. A severe exacerbation is defined as one requiring hospital admission.
- Patients with a persistent arterial pH<7.30 due primarily to hypercapnic respiratory failure after standard medical therapy and at least 1 hour of NIV.
- Age over 18
Key exclusion criteria (23 listed)
- Haemodynamic instability after ensuring euvolaemia
- Acute multiple organ failure requiring other organ supportive therapy, including indication for intubation and mechanical ventilation
- Known allergy/intolerance of heparin including known heparin induced thrombosis and thrombocytopaenia
- Acute uncontrolled haemorrhage
- Intracerebral haemorrhage
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 |
|---|---|---|
| NIVStandard care | Device | ECCO2R, NIV |
| ECCO2RAlso: HaemolungApplication of ECCO2R in addition to NIV | Device | ECCO2R |
Primary outcome
Time to cessation NIV
Time frame: participants will be followed for the duration of ICU stay, an expected average of 4 days
Time to cessation of NIV is defined as from NIV commencement to 6 hours without NIV.
18 secondary outcomes
Mortality
Time frame: at 90 days
Time to event analysis
Time frame: initial phase of study, an expected average of 3 hours
Health-related quality of life (HRQoL)
Time frame: 90 days
Cannulation-related outcomes
Time frame: participants will be followed for the duration of ICU stay, an expected average of 4 days
haemolysis related to the intervention
Time frame: participants will be followed for the duration of ICU stay, an expected average of 4 days
work of breathing
Time frame: participants will be followed for the duration of ICU stay, an expected average of 4 days
Time to cessation ECCO2R
Time frame: participants will be followed for the duration of ICU stay, an expected average of 4 days
Time to normalisation of pH
Time frame: participants will be followed for the duration of ICU stay, an expected average of 4 days
Hospital Length of stay
Time frame: participants will be followed for the duration of hospital stay, an expected average of 10 days
Intubation rate
Time frame: participants will be followed for the duration of ICU stay, an expected average of 4 days
Incidence of tracheostomy
Time frame: participants will be followed for the duration of ICU stay, an expected average of 4 days
length of ICU stay
Time frame: participants will be followed for the duration of ICU stay, an expected average of 4 days
Tolerance of therapy
Time frame: participants will be followed for the duration of ICU stay, an expected average of 4 days
subjective dyspnoea
Time frame: participants will be followed for the duration of ICU stay, an expected average of 4 days
nutrition
Time frame: participants will be followed for the duration of ICU stay, an expected average of 4 days
Mobilisation
Time frame: participants will be followed for the duration of ICU stay, an expected average of 4 days
thrombotic complications
Time frame: participants will be followed for the duration of ICU stay, an expected average of 4 days
respiratory mechanics
Time frame: participants will be followed for the duration of ICU stay, an expected average of 4 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2021.
- Derived from this study: PubMed 39639560Barrett NA, Murgolo F, Grasso S, Kostakou E, Hart N, Murphy P, Douiri A, Camporota L. Physiological Assessment of ECCO2R on the Work of Breathing in Exacerbations of COPD. COPD. 2024 Dec;21(1):2436169. doi: 10.1080/15412555.2024.2436169. Epub 2024 Dec 5.
- Derived from this study: PubMed 35445986Barrett NA, Hart N, Daly KJR, Marotti M, Kostakou E, Carlin C, Lua S, Singh S, Bentley A, Douiri A, Camporota L. A randomised controlled trial of non-invasive ventilation compared with extracorporeal carbon dioxide removal for acute hypercapnic exacerbations of chronic obstructive pulmonary disease. Ann Intensive Care. 2022 Apr 21;12(1):36. doi: 10.1186/s13613-022-01006-8.
- Derived from this study: PubMed 31928313Barrett NA, Hart N, Camporota L. In vivo carbon dioxide clearance of a low-flow extracorporeal carbon dioxide removal circuit in patients with acute exacerbations of chronic obstructive pulmonary disease. Perfusion. 2020 Jul;35(5):436-441. doi: 10.1177/0267659119896531. Epub 2020 Jan 11.
- Derived from this study: PubMed 31362776Barrett NA, Kostakou E, Hart N, Douiri A, Camporota L. Extracorporeal carbon dioxide removal for acute hypercapnic exacerbations of chronic obstructive pulmonary disease: study protocol for a randomised controlled trial. Trials. 2019 Jul 30;20(1):465. doi: 10.1186/s13063-019-3548-4.
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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.
Nicholas Barrett, FCICM principal investigator
Guy's and St Thomas' NHS Foundation Trust
Luigi Camporota, PhD principal investigator
Guy's and St Thomas' NHS Foundation Trust
Nicholas Hart, PhD principal investigator
Guy's and St Thomas' NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NIV and ECCO2R in people with Chronic Obstructive Pulmonary Disease, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
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 3 inclusion and 23 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: finished, as of the sponsor's last update on 11 Aug 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 United Kingdom. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to cessation NIV (time frame: participants will be followed for the duration of ICU stay, an expected average of 4 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02086084, which also lists 4 linked publications.
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 11 Aug 2021; AzTrials last refreshed its copy on 30 Oct 2026.