Status:
UNKNOWN
Exacerbation Prevention GOLD IV COPD With Non Invasive Mechanical Ventilation
Lead Sponsor:
National Institute of Respiratory Diseases, Mexico
Conditions:
Chronic Obstructive Pulmonary Disease
Eligibility:
All Genders
45-85 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to evaluate the efficacy of high-intensity non invasive mechanical ventilation (during one year to reduce the severity and frequency of acute exacerbation of chronic obstr...
Detailed Description
Background: * There are many previous studies (no controlled trials or observational studies)that demonstrated minimal benefits (on gas exchange and marginal effect over exacerbations frequency) with...
Eligibility Criteria
Inclusion
- Clinical and spirometric diagnosis for COPD (FEV1/FVC \<70%)
- Clinical phenotype of frequent exacerbations
- Must sign the informed consent
- Former smokers
- Stable COPD
- FEV1 \<35%
- Optimal medical treatment
Exclusion
- OSAS diagnosis
- Other indications for non invasive mechanical ventilation
- Arterial pressure for dioxide carbon \>45mmHg
- Lung cancer
- Impossibility for doing spirometry or going to the medical visits
- Be included in another study
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01481727
Start Date
December 1 2011
End Date
December 1 2015
Last Update
May 25 2015
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
National Institute of Respiratory Diseases
Mexico City, Mexico City, Mexico, 14080