Chronic Obstructive Pulmonary Disease PatientsNCT02260583
Effect of Extracorporeal CO2 Removal in Stable Hypercapnic COPD Patients
A study testing extracorporeal CO2 device in people with Chronic Obstructive Pulmonary Disease Patients and Chronic Respiratory Failure, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease Patients, Chronic Respiratory Failure
- What is being tested?
- extracorporeal CO2 device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteItaly
- Study dates
- Oct 2014to Dec 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Mean Arterial Pressure < 60 mmHg
- contra-indication to heparin
- Body Mass Index (BMI) > 30 kg/m2;
- presence of sleep apnea or overall syndrome
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
san'Orsola Malpighi Hospital, Bologna ITALY
Bologna, 40138
stefano nava, md, 051 6364017, stefano.nava@aosp.bo.it
lara pisani, md, 0516363253, lara.pisani@unibo.it
About this study
Official title: EFFECT OF EXTRACORPOREAL CO2 REMOVAL IN STABLE COPD PATIENTS WITH CHRONIC HYPERCAPNIC RESPIRATORY FAILURE:A PILOT STUDY
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
Read the 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.
- Being tested
- extracorporeal CO2 device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
extracorporeal CO2 deviceDevice
An ECCO2R device based on a modified continuous venovenous hemofiltration system will be used
| Study group | Role | What they receive |
|---|---|---|
| extracorporeal CO2 removal device | Experimental | the patients will be enroll to start a "one shot" session of extracorporeal CO2 removal. The patient will be connected to the device via a double lumen catheter inserted in the femoral vein An ECCO2R device based on a modified continuous venovenous hemofiltration system will be used. Blood flow is driven by a roller nonocclusive pump (0-450 mL/min) through a polypropylene oxygenator ; priming volume, 100 mL; contact surface area, 1.35 m2; maximum blood flow rate, 7 L/min) that is connected to a fresh gas flow source delivering 100% oxygen at a constant rate of 8 L/min. Exiting the oxygenator, blood is driven to a hemofilter. Receives: Device: extracorporeal CO2 device |
What is being measured
The primary outcome is the main question the study is designed to answer.
arterial blood gases
Measured: 30 days
Secondary outcomes (1)
respiratory rate, dyspnea
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary Disease PatientsStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe 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
- 15 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, dr. Stefano Nava, IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Investigators
- stefano nava, Principal investigator, sant'orsola malpighi hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02260583
- Sponsor's protocol ID
- 176/2013
- Status last verified
- Dec 2017
- First submitted
- 6 Oct 2014
- Last updated
- 29 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFECT OF EXTRACORPOREAL CO2 REMOVAL IN STABLE COPD PATIENTS WITH CHRONIC HYPERCAPNIC RESPIRATORY FAILURE:A PILOT STUDY
- ClinicalTrials.gov ID
- NCT02260583
- Acronym / sponsor ID
- 176/2013
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- Oct 2014 (actual)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 9 Oct 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 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.
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 device | Experimental | Device: extracorporeal CO2 devicethe patients will be enroll to start a "one shot" session of extracorporeal CO2 removal. The patient will be connected to the device via a double lumen catheter inserted in the femoral vein An ECCO2R device based on a modified continuous venovenous hemofiltration system will be used. Blood flow is driven by a roller nonocclusive pump (0-450 mL/min) through a polypropylene oxygenator ; priming volume, 100 mL; contact surface area, 1.35 m2; maximum blood flow rate, 7 L/min) that is connected to a fresh gas flow source delivering 100% oxygen at a constant rate of 8 L/min. Exiting the oxygenator, blood is driven to a hemofilter. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- Mean Arterial Pressure < 60 mmHg
- contra-indication to heparin
- Body Mass Index (BMI) > 30 kg/m2;
- presence of sleep apnea or overall syndrome
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 deviceAn ECCO2R device based on a modified continuous venovenous hemofiltration system will be used | Device | extracorporeal CO2 removal device |
Primary outcome
arterial blood gases
Time frame: 30 days
1 secondary outcome
respiratory rate, dyspnea
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2017.
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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.
stefano nava principal investigator
sant'orsola malpighi 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 extracorporeal CO2 device in people with Chronic Obstructive Pulmonary Disease Patients and Chronic Respiratory Failure, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
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 4 inclusion and 4 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 29 Dec 2017. 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 Italy. 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 stefano nava (051 6364017, stefano.nava@aosp.bo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
arterial blood gases (time frame: 30 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 29 Dec 2017.