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Exacerbation Prevention GOLD IV COPD With Non Invasive Mechanical Ventilation

NCT01481727 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2015-05-25

No results posted yet for this study

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 obstructive pulmonary disease (AECOPD) in patients with frequent AECOPD (frequent exacerbations defined more two or more AECOPD) and in GOLD IV stage (very severe COPD). The design is a randomised, double blind and controled with placebo (sham maneuver) clinical trial.

Conditions

Interventions

DEVICE

BiPAP Pro 2, Phillips Respironics

mechanical ventilation type bilevel at high intensity (\>18mmHg) for at least six hours, nocturnal ventilation.

DEVICE

CPAP sham

CPAP sham maneuver (IPAP less or equal to 4cmH2O)

Sponsors & Collaborators

  • National Institute of Respiratory Diseases, Mexico

    lead OTHER_GOV

Principal Investigators

  • RAUL HUMBERTO SANSORES MARTINEZ, MMS and MD · Instituto Nacional de Enfermedades Respiratorias

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-12-31
Primary Completion
2015-03-31
Completion
2015-12-31

Countries

  • Mexico

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01481727 on ClinicalTrials.gov