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Effect of Extracorporeal CO2 Removal in Stable Hypercapnic COPD Patients

EFFECT OF EXTRACORPOREAL CO2 REMOVAL IN STABLE COPD PATIENTS WITH CHRONIC HYPERCAPNIC RESPIRATORY FAILURE:A PILOT STUDY

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02260583
Enrollment
15
Registered
2014-10-09
Start date
2014-10-31
Completion date
2018-12-31
Last updated
2017-12-29

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

Conditions

Chronic Obstructive Pulmonary Disease Patients, Chronic Respiratory Failure

Brief summary

Chronic hypercapnic respiratory failure is common in stable COPD patients in a terminal phase of their disease In an attempt to correct or slow down the rate of rise of PaCO2, long-term noninvasive mechanical ventilation (NIV) has been proposed. Only very few studies demonstrated the clinical efficacy of NIV. Indeed this technique is not always well tolerated and therefore it may be effective only in a subset of patients The aim of this study is to assess the feasibility and safety of one shot extrcorporeal CO2 removal device, in reducing the PaCO2 level

Detailed description

Chronic hypercapnic respiratory failure is common in stable COPD patients in a terminal phase of their disease In an attempt to correct or slow down the rate of rise of PaCO2, long-term noninvasive mechanical ventilation (NIV) has been proposed. Only very few studies demonstrated the clinical efficacy of NIV. Indeed this technique is not always well tolerated and therefore it may be effective only in a subset of patients Recently extracorporeal CO2 removal have been shown to avoid the need of endotracheal intubation in COPD patients with an episode of Acute Hypercapnic Respiratory Failure In this pilot physiological study we want to assess the safety and efficacy of this technique in reducing the PaCO2 level in those COPD patients with chronic hypercapnic respiratory failure non responding to chronic NIV.

Interventions

DEVICEextracorporeal CO2 device

An ECCO2R device based on a modified continuous venovenous hemofiltration system will be used

Sponsors

IRCCS Azienda Ospedaliero-Universitaria di Bologna
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

Inclusion criteria

* COPD ( FEV1/CVF \<0.70 post bronchodilation) * stable PaCO2 \>55 mmHg non respondent to long-term NIV (at least one week). This means a decrease in PaCO2 during spontaneous breathing, at least 4 hrs after the termination of NIV, of\< 6% * pH \> 7.35 * clinical stability

Exclusion criteria

* Mean Arterial Pressure \< 60 mmHg * contra-indication to heparin * Body Mass Index (BMI) \> 30 kg/m2; * presence of sleep apnea or overall syndrome

Design outcomes

Primary

MeasureTime frame
arterial blood gases30 days

Secondary

MeasureTime frame
respiratory rate, dyspnea30 days

Countries

Italy

Contacts

Primary Contactstefano nava
stefano.nava@aosp.bo.it051 6364017

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026