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Effect of Extracorporeal CO2 Removal in Stable Hypercapnic COPD Patients

Primary Purpose

Chronic Obstructive Pulmonary Disease Patients, Chronic Respiratory Failure

Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
extracorporeal CO2 device
Sponsored by
IRCCS Azienda Ospedaliero-Universitaria di Bologna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease Patients

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • san'Orsola Malpighi Hospital, Bologna ITALYRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

extracorporeal CO2 removal device

Arm Description

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.

Outcomes

Primary Outcome Measures

arterial blood gases

Secondary Outcome Measures

respiratory rate, dyspnea

Full Information

First Posted
October 6, 2014
Last Updated
December 27, 2017
Sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna
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1. Study Identification

Unique Protocol Identification Number
NCT02260583
Brief Title
Effect of Extracorporeal CO2 Removal in Stable Hypercapnic COPD Patients
Official Title
EFFECT OF EXTRACORPOREAL CO2 REMOVAL IN STABLE COPD PATIENTS WITH CHRONIC HYPERCAPNIC RESPIRATORY FAILURE:A PILOT STUDY
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Unknown status
Study Start Date
October 2014 (Actual)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease Patients, Chronic Respiratory Failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
extracorporeal CO2 removal device
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
extracorporeal CO2 device
Intervention Description
An ECCO2R device based on a modified continuous venovenous hemofiltration system will be used
Primary Outcome Measure Information:
Title
arterial blood gases
Time Frame
30 days
Secondary Outcome Measure Information:
Title
respiratory rate, dyspnea
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
stefano nava
Phone
051 6364017
Email
stefano.nava@aosp.bo.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
stefano nava
Organizational Affiliation
sant'orsola malpighi hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
san'Orsola Malpighi Hospital, Bologna ITALY
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
stefano nava, md
Phone
051 6364017
Email
stefano.nava@aosp.bo.it
First Name & Middle Initial & Last Name & Degree
lara pisani, md
Phone
0516363253
Email
lara.pisani@unibo.it

12. IPD Sharing Statement

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Effect of Extracorporeal CO2 Removal in Stable Hypercapnic COPD Patients

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