Chronic Obstructive Pulmonary DiseaseEPHEBENCT02586948
Physiological Study of Minimally Invasive ECCO2R in Exacerbations of COPD Requiring Invasive Mechanical Ventilation
A study testing extracorporeal CO2 removal (Hemolung device) in people with Chronic Obstructive Pulmonary Disease, run by Assistance Publique - Hôpitaux de Paris at 3 sites in France.
Trial summary
Morbidity and mortality in COPD result largely of acute exacerbations.The optimization of the respiratory management represents a fundamental challenge for improving prognosis and reducing mortality. 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?
- extracorporeal CO2 removal (Hemolung device)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 3 sitesFrance
- Study dates
- Jul 2016to 12 Feb 2018
- 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
- clinical exacerbation of a known or suspected COPD
- intubation and invasive mechanical ventilation since less than 72 hrs.
- ACV or CV mode (VT 8 ml/kg, RR 12/min., PEEP : 0 cmH20)
- pH < 7.30 and PaCO2 > 55 mm Hg and PEEPi (end-expiratory occlusion) > 5 cmH20
- written inform consent (patient, patient's legal surrogate)
- affiliation to a social security regime
Who cannot join
- Body Mass Index (BMI) > 35 kg/m2
- PaO2/FiO2 < 200 mm Hg
- history of hemorrhagic stroke
- heparin-induced thrombocytopenia
- Severe thrombopenia type II history
Trial locations and contacts
3 sites in 1 country.
France3 sites
CHU d'Angers
Angers, 49933
Hopital de Bicetre, Hopitaux universitaires Paris Sud
Le Kremlin-Bicêtre, 94275
Hopital Europeen Georges Pompidou
Paris, 75015
About this study
Official title: Physiological Study of Minimally Invasive Extracorporeal CO2 Removal in Exacerbations of COPD Requiring Invasive Mechanical Ventilation
Morbidity and mortality in COPD result largely of acute exacerbations.The optimization of the respiratory management represents a fundamental challenge for improving prognosis and reducing mortality. While the hospital mortality of patients treated with NIV has decreased over years, and is currently less than 10 %, mortality in patients treated with invasive ventilation remains higher than 25%. To improve the prognosis of patients with acute exacerbation of COPD requiring invasive mechanical ventilation is therefore a major challenge in terms of morbidity and mortality. Among the means available to achieve this goal, minimally invasive extracorporeal CO2 removal (ECCO2R) seems to be a very promising approach.
The investigators hypothesize that the addition of minimally invasive ECCO2R is likely to limit dynamic hyperinflation in COPD patients requiring invasive mechanical ventilation for an acute exacerbation, while improving gas exchange.
Read the detailed description
Chronic obstructive pulmonary disease (COPD) is currently the fourth leading cause of death in the U.S. and is expected to become the third leading cause of death in 2020. Morbidity and mortality in COPD result largely of acute exacerbations, which are responsible for 1.5 million ED visits and 750,000 hospitalizations per year in the U.S. The optimization of the respiratory management of acute exacerbations represents a fundamental challenge for improving prognosis and reducing mortality. The value of non-invasive ventilation (NIV) for severe acute exacerbations of COPD was formally demonstrated by randomized clinical trials. In the setting of severe COPD exacerbations, NIV is actually very largely employed, largely ahead from invasive mechanical ventilation. While the hospital mortality of patients treated with NIV has decreased over years, and is currently less than 10 %, mortality in patients treated with invasive ventilation remains as high than 25%. Mortality in patients treated with invasive ventilation after failure of NIV seems to be growing and is actually close to 30%. To improve the prognosis of patients with acute exacerbation of COPD requiring invasive mechanical ventilation is therefore a major challenge in terms of morbidity and mortality. Among the means available to achieve this goal, minimally invasive extracorporeal CO2 removal (ECCO2R) seems to be a very promising approach.
The investigators hypothesize that the addition of minimally invasive ECCO2R is likely to limit dynamic hyperinflation in COPD patients requiring invasive ventilation for an acute exacerbation, while improving gas exchange. If confirmed, it could imply a more rapid weaning from invasive ventilation in relation to:
- less hemodynamic consequences of positive pressure ventilation
- reduced risk of baro-volo trauma of the lung parenchyma
- reduction in the use of sedative drugs
- a chest configuration minimizing diaphragmatic flattening, therefore favoring the generation of higher trans-diaphragmatic pressures
- a decrease in the work of breathing (WOB), in connection with the previous point and with a decrease in alveolar ventilation required for pulmonary CO2 elimination during the ECCO2R treatment All of these elements are clinically relevant, as a reduction in the duration of invasive ventilation is associated in the literature with a decrease in the incidence of pneumonia associated with mechanical ventilation, as well as with a decrease in the duration of ICU-stay.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- extracorporeal CO2 removal (Hemolung device)
- Keywords
- extracorporeal CO2 removal
- 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.
extracorporeal CO2 removal (Hemolung device)Device
Also called ECCO2R
ECCO2R in severe exacerbation of COPD patients, requiring invasive mechanical ventilation with persistent respiratory acidosis and dynamic hyperinflation
| Study group | Role | What they receive |
|---|---|---|
| extracorporeal CO2 removal | Experimental | extracorporeal CO2 removal initiated shortly after intubation, using the veno-venous Hemolung device Receives: Device: extracorporeal CO2 removal (Hemolung device) |
What is being measured
The primary outcome is the main question the study is designed to answer.
intrinsic PEEP (PEEPi)
PEEPi at baseline and after ECCO2R by the Hemolung® device and adjustment of ventilator settings, expressed in cmH20
Measured: 12 hours (between measurements at baseline and under ECCO2R)
Secondary outcomes (17)
Functional Residual capacity (FRC)
FRC using the nitrogen washout method, expressed in mL
Measured: 12 hours (between measurements at baseline and under ECCO2R)
PaO2
PaO2 expressed in mmHg
Measured: 12 hours (between measurements at baseline and under ECCO2R)
PaCO2
PaCO2 expressed in mmHg
Measured: 12 hours (between measurements at baseline and under ECCO2R)
Arterial O2 saturation
Arterial O2 saturation expressed in %
Measured: 12 hours (between measurements at baseline and under ECCO2R)
pH
pH expressed in absolute value
Measured: 12 hours (between measurements at baseline and under ECCO2R)
amount of sedative drugs
amount of sedative drugs (per day and cumulative)
Measured: Average time period of 6 days
length of intubation
length of intubation (days)
Measured: Average time period of 7 days, up to 28 days
length of ICU-stay
length of ICU-stay (days)
Measured: Average time period of 8 days, up to 28 days
length of hospital stay
length of hospital stay (days)
Measured: Average time period of 9 days, up to 28 days
ICU mortality
Number of in ICU-deceased participants (expressed in absolute number and %)
Measured: Average time period of 9 days, up to 28 days
catheter related complications
catheter related complications (thrombosis, bleeding, pneumothorax, infection) expressed in total number of complications, in average number of complications per participant and in number of patients with complications
Measured: Average time period of 9 days
Hemolung related complications
Hemolung related complications (thrombosis, bleeding) expressed in total number of complications, in average number of complications per participant and in number of patients with complications
Measured: Average time period of 9 days
non catheter-related bleedings
non catheter-related bleedings expressed in total number of bleedings, in average number of bleedings per participant and in number of patients with bleedings
Measured: Average time period of 9 days
work of breathing per Liter
work of breathing with and without ECCO2R, expressed in Joules per Liter of ventilation
Measured: Average time period of 7 days
work of breathing per minute
work of breathing with and without ECCO2R, expressed in Joules per minute
Measured: Average time period of 7 days
work of breathing per breath
work of breathing with and without ECCO2R, expressed in Joules per breath
Measured: Average time period of 7 days
Occlusion pressure in 100msec (P0.1)
Occlusion pressure in 100msec in parallel to work breathing measurements with and without ECCO2, expressed in cmH2O
Measured: Average time period of 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2015 (estimated)
- Study startJul 2016
- Primary completion14 Jan 2018
- Study completion12 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Alung Technologies
- Responsible party
- Sponsor
- Investigators
- Jean-Luc Diehl, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02586948
- Sponsor's protocol ID
- HAO14044
- Acronym
- EPHEBE
- Status last verified
- Feb 2018
- First submitted
- 31 Aug 2015
- Last updated
- 27 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Diehl JL, Piquilloud L, Vimpere D, Aissaoui N, Guerot E, Augy JL, Pierrot M, Hourton D, Arnoux A, Richard C, Mancebo J, Mercat A. Physiological effects of adding ECCO2R to invasive mechanical ventilation for COPD exacerbations. Ann Intensive Care. 2020 Sep 29;10(1):126. doi: 10.1186/s13613-020-00743-y.
PubMed 32990836
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiological Study of Minimally Invasive Extracorporeal CO2 Removal in Exacerbations of COPD Requiring Invasive Mechanical Ventilation
- ClinicalTrials.gov ID
- NCT02586948
- Acronym / sponsor ID
- EPHEBE / HAO14044
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- extracorporeal CO2 removal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Alung Technologies
- Study start
- Jul 2016
- Primary completion
- 14 Jan 2018 (actual)
- Study completion
- 12 Feb 2018 (actual)
- First posted
- 27 Oct 2015 (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.
Morbidity and mortality in COPD result largely of acute exacerbations.The optimization of the respiratory management represents a fundamental challenge for improving prognosis and reducing mortality. While the hospital mortality of patients treated with NIV has decreased over years, and is currently less than 10 %, mortality in patients treated with invasive ventilation remains higher than 25%. To improve the prognosis of patients with acute exacerbation of COPD requiring invasive mechanical ventilation is therefore a major challenge in terms of morbidity and mortality. Among the means available to achieve this goal, minimally invasive extracorporeal CO2 removal (ECCO2R) seems to be a very promising approach.
The investigators hypothesize that the addition of minimally invasive ECCO2R is likely to limit dynamic hyperinflation in COPD patients requiring invasive mechanical ventilation for an acute exacerbation, while improving gas exchange.
Detailed description
Chronic obstructive pulmonary disease (COPD) is currently the fourth leading cause of death in the U.S. and is expected to become the third leading cause of death in 2020. Morbidity and mortality in COPD result largely of acute exacerbations, which are responsible for 1.5 million ED visits and 750,000 hospitalizations per year in the U.S. The optimization of the respiratory management of acute exacerbations represents a fundamental challenge for improving prognosis and reducing mortality. The value of non-invasive ventilation (NIV) for severe acute exacerbations of COPD was formally demonstrated by randomized clinical trials. In the setting of severe COPD exacerbations, NIV is actually very largely employed, largely ahead from invasive mechanical ventilation. While the hospital mortality of patients treated with NIV has decreased over years, and is currently less than 10 %, mortality in patients treated with invasive ventilation remains as high than 25%. Mortality in patients treated with invasive ventilation after failure of NIV seems to be growing and is actually close to 30%. To improve the prognosis of patients with acute exacerbation of COPD requiring invasive mechanical ventilation is therefore a major challenge in terms of morbidity and mortality. Among the means available to achieve this goal, minimally invasive extracorporeal CO2 removal (ECCO2R) seems to be a very promising approach.
The investigators hypothesize that the addition of minimally invasive ECCO2R is likely to limit dynamic hyperinflation in COPD patients requiring invasive ventilation for an acute exacerbation, while improving gas exchange. If confirmed, it could imply a more rapid weaning from invasive ventilation in relation to:
- less hemodynamic consequences of positive pressure ventilation
- reduced risk of baro-volo trauma of the lung parenchyma
- reduction in the use of sedative drugs
- a chest configuration minimizing diaphragmatic flattening, therefore favoring the generation of higher trans-diaphragmatic pressures
- a decrease in the work of breathing (WOB), in connection with the previous point and with a decrease in alveolar ventilation required for pulmonary CO2 elimination during the ECCO2R treatment All of these elements are clinically relevant, as a reduction in the duration of invasive ventilation is associated in the literature with a decrease in the incidence of pneumonia associated with mechanical ventilation, as well as with a decrease in the duration of ICU-stay.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| extracorporeal CO2 removal | Experimental | Device: extracorporeal CO2 removal (Hemolung device)extracorporeal CO2 removal initiated shortly after intubation, using the veno-venous Hemolung device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- clinical exacerbation of a known or suspected COPD
- intubation and invasive mechanical ventilation since less than 72 hrs.
- ACV or CV mode (VT 8 ml/kg, RR 12/min., PEEP : 0 cmH20)
- pH < 7.30 and PaCO2 > 55 mm Hg and PEEPi (end-expiratory occlusion) > 5 cmH20
- written inform consent (patient, patient's legal surrogate)
Key exclusion criteria (5 listed)
- Body Mass Index (BMI) > 35 kg/m2
- PaO2/FiO2 < 200 mm Hg
- history of hemorrhagic stroke
- heparin-induced thrombocytopenia
- Severe thrombopenia type II history
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 CO2 removal (Hemolung device)Also: ECCO2RECCO2R in severe exacerbation of COPD patients, requiring invasive mechanical ventilation with persistent respiratory acidosis and dynamic hyperinflation | Device | extracorporeal CO2 removal |
Primary outcome
intrinsic PEEP (PEEPi)
Time frame: 12 hours (between measurements at baseline and under ECCO2R)
PEEPi at baseline and after ECCO2R by the Hemolung® device and adjustment of ventilator settings, expressed in cmH20
17 secondary outcomes
Functional Residual capacity (FRC)
Time frame: 12 hours (between measurements at baseline and under ECCO2R)
PaO2
Time frame: 12 hours (between measurements at baseline and under ECCO2R)
PaCO2
Time frame: 12 hours (between measurements at baseline and under ECCO2R)
Arterial O2 saturation
Time frame: 12 hours (between measurements at baseline and under ECCO2R)
pH
Time frame: 12 hours (between measurements at baseline and under ECCO2R)
amount of sedative drugs
Time frame: Average time period of 6 days
length of intubation
Time frame: Average time period of 7 days, up to 28 days
length of ICU-stay
Time frame: Average time period of 8 days, up to 28 days
length of hospital stay
Time frame: Average time period of 9 days, up to 28 days
ICU mortality
Time frame: Average time period of 9 days, up to 28 days
catheter related complications
Time frame: Average time period of 9 days
Hemolung related complications
Time frame: Average time period of 9 days
non catheter-related bleedings
Time frame: Average time period of 9 days
work of breathing per Liter
Time frame: Average time period of 7 days
work of breathing per minute
Time frame: Average time period of 7 days
work of breathing per breath
Time frame: Average time period of 7 days
Occlusion pressure in 100msec (P0.1)
Time frame: Average time period of 7 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 27 Feb 2018.
- Derived from this study: PubMed 32990836Diehl JL, Piquilloud L, Vimpere D, Aissaoui N, Guerot E, Augy JL, Pierrot M, Hourton D, Arnoux A, Richard C, Mancebo J, Mercat A. Physiological effects of adding ECCO2R to invasive mechanical ventilation for COPD exacerbations. Ann Intensive Care. 2020 Sep 29;10(1):126. doi: 10.1186/s13613-020-00743-y.
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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.
Jean-Luc Diehl principal investigator
Assistance Publique - Hôpitaux de Paris
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing extracorporeal CO2 removal (Hemolung device) in people with Chronic Obstructive Pulmonary Disease, run by Assistance Publique - Hôpitaux de Paris at 3 sites in France.
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 6 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: finished, as of the sponsor's last update on 27 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. 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?
intrinsic PEEP (PEEPi) (time frame: 12 hours (between measurements at baseline and under ECCO2R)). 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 NCT02586948, which also lists 1 linked publication.
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 27 Feb 2018.