Effect of Extracorporeal CO2 Removal in Stable Hypercapnic COPD Patients

Chronic Respiratory Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02260583
• Other study ID #: 176/2013
• Status: Recruiting
• Phase: N/A
• First received: October 6, 2014
• Last updated: December 27, 2017
• Start date: October 2014
• Est. completion date: December 2018

Study information

• Verified date: December 2017
• Source: Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
• Contact: stefano nava
• Phone: 051 6364017
• Email: stefano.nava[@]aosp.bo.it
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease Patients
• Chronic Respiratory Failure
• Hypercapnia
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive
• Respiratory Insufficiency

Intervention

Device:
• extracorporeal CO2 device
An ECCO2R device based on a modified continuous venovenous hemofiltration system will be used

Locations

Country	Name	City	State
Italy	san'Orsola Malpighi Hospital, Bologna ITALY	Bologna

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	arterial blood gases		30 days
Secondary	respiratory rate, dyspnea		30 days