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Trial record 53 of 667 for:    CARBON DIOXIDE AND arterial

Effect of Extracorporeal CO2 Removal in Stable Hypercapnic COPD Patients

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ClinicalTrials.gov Identifier: NCT02260583
Recruitment Status : Recruiting
First Posted : October 9, 2014
Last Update Posted : December 29, 2017
Sponsor:
Information provided by (Responsible Party):
dr. Stefano Nava, Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi

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


Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Patients Chronic Respiratory Failure Device: extracorporeal CO2 device Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: EFFECT OF EXTRACORPOREAL CO2 REMOVAL IN STABLE COPD PATIENTS WITH CHRONIC HYPERCAPNIC RESPIRATORY FAILURE:A PILOT STUDY
Actual Study Start Date : October 2014
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: extracorporeal CO2 removal device
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.
Device: extracorporeal CO2 device
An ECCO2R device based on a modified continuous venovenous hemofiltration system will be used




Primary Outcome Measures :
  1. arterial blood gases [ Time Frame: 30 days ]

Secondary Outcome Measures :
  1. respiratory rate, dyspnea [ Time Frame: 30 days ]


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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02260583


Contacts
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Contact: stefano nava 051 6364017 stefano.nava@aosp.bo.it

Locations
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Italy
san'Orsola Malpighi Hospital, Bologna ITALY Recruiting
Bologna, Italy, 40138
Contact: stefano nava, md    051 6364017    stefano.nava@aosp.bo.it   
Contact: lara pisani, md    0516363253    lara.pisani@unibo.it   
Sponsors and Collaborators
Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
Investigators
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Principal Investigator: stefano nava sant'orsola malpighi hospital

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Responsible Party: dr. Stefano Nava, PRofessor of Respiratory Medicine, Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
ClinicalTrials.gov Identifier: NCT02260583     History of Changes
Other Study ID Numbers: 176/2013
First Posted: October 9, 2014    Key Record Dates
Last Update Posted: December 29, 2017
Last Verified: December 2017
Additional relevant MeSH terms:
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Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Insufficiency
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders