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Physiological Study of Minimally Invasive ECCO2R in Exacerbations of COPD Requiring Invasive Mechanical Ventilation

Physiological Study of Minimally Invasive Extracorporeal CO2 Removal in Exacerbations of COPD Requiring Invasive Mechanical Ventilation

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02586948
Acronym
EPHEBE
Enrollment
12
Registered
2015-10-27
Start date
2016-07-31
Completion date
2018-02-12
Last updated
2018-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

extracorporeal CO2 removal

Brief 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. 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.

Interventions

DEVICEextracorporeal CO2 removal (Hemolung device)

ECCO2R in severe exacerbation of COPD patients, requiring invasive mechanical ventilation with persistent respiratory acidosis and dynamic hyperinflation

Sponsors

Alung Technologies
CollaboratorINDUSTRY
Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* Body Mass Index (BMI) \> 35 kg/m2 * PaO2/FiO2 \< 200 mm Hg * history of hemorrhagic stroke * heparin-induced thrombocytopenia * Severe thrombopenia type II history

Design outcomes

Primary

MeasureTime frameDescription
intrinsic PEEP (PEEPi)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

Secondary

MeasureTime frameDescription
PaO212 hours (between measurements at baseline and under ECCO2R)PaO2 expressed in mmHg
PaCO212 hours (between measurements at baseline and under ECCO2R)PaCO2 expressed in mmHg
Arterial O2 saturation12 hours (between measurements at baseline and under ECCO2R)Arterial O2 saturation expressed in %
pH12 hours (between measurements at baseline and under ECCO2R)pH expressed in absolute value
amount of sedative drugsAverage time period of 6 daysamount of sedative drugs (per day and cumulative)
length of intubationAverage time period of 7 days, up to 28 dayslength of intubation (days)
length of ICU-stayAverage time period of 8 days, up to 28 dayslength of ICU-stay (days)
length of hospital stayAverage time period of 9 days, up to 28 dayslength of hospital stay (days)
Functional Residual capacity (FRC)12 hours (between measurements at baseline and under ECCO2R)FRC using the nitrogen washout method, expressed in mL
catheter related complicationsAverage time period of 9 dayscatheter 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
Hemolung related complicationsAverage time period of 9 daysHemolung related complications (thrombosis, bleeding) expressed in total number of complications, in average number of complications per participant and in number of patients with complications
non catheter-related bleedingsAverage time period of 9 daysnon catheter-related bleedings expressed in total number of bleedings, in average number of bleedings per participant and in number of patients with bleedings
work of breathing per LiterAverage time period of 7 dayswork of breathing with and without ECCO2R, expressed in Joules per Liter of ventilation
work of breathing per minuteAverage time period of 7 dayswork of breathing with and without ECCO2R, expressed in Joules per minute
work of breathing per breathAverage time period of 7 dayswork of breathing with and without ECCO2R, expressed in Joules per breath
Occlusion pressure in 100msec (P0.1)Average time period of 7 daysOcclusion pressure in 100msec in parallel to work breathing measurements with and without ECCO2, expressed in cmH2O
ICU mortalityAverage time period of 9 days, up to 28 daysNumber of in ICU-deceased participants (expressed in absolute number and %)

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 25, 2026