Chronic Obstructive Pulmonary Disease
Conditions
Keywords
acute exacerbation of COPD number, acute exacerbation of COPD severity
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 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.
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 the use of non invasive mechanical ventilation, in BiPAP modality with IPAP pressures \<18H2ocm (low intensity), in COPD patients. * In subsequent years there were controled trials that concluded that there was no benefits with the use of non invasive mechanical ventilation on BiPAP mode in COPD patients ( It should be mentioned that in most trials were used low inspiratory pressure levels, that is called low-intensity non invasive mechanical ventilation). * However, there are other recent studies that described some benefits of high intensity Bilevel modality of non invasive mechanical ventilation (inspiratory pressures \>18cmH2O) specially on gas exchange, quality of life and functional status. * There are some issues that do not yet have a clear answer like the optimal inspiratory pressure (IPAP) or the ventilation modality (BIPAP or other) to obtain the maximal benefit on COPD patients. Additionally, is not clear also if the use of non invasive mechanical ventilation on COPD patients helps to reduce the frequency and severity of acute exacerbations of COPD (AECOPD). This study have some characteristics that are different to the previous reports: * The inclusion of patients with frequent exacerbations phenotype (and therefore worst prognosis patients)that there are no included in previous trials * The intervention maneuver that is bilevel modality of non invasive mechanical ventilation at hig-intensity pressure (\>18H2Ocm and \<24H2Ocm) * The use of placebo maneuver (CPAP Sham) * The home titration in three phases, over a week * The long-term use of the intervention and sham maneuver
Interventions
DEVICEBiPAP Pro 2, Phillips Respironics
mechanical ventilation type bilevel at high intensity (\>18mmHg) for at least six hours, nocturnal ventilation.
DEVICECPAP sham
CPAP sham maneuver (IPAP less or equal to 4cmH2O)
Sponsors
National Institute of Respiratory Diseases, Mexico
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
45 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| acute exacerbations of Chronic Obstructive Pulmonary Disease frequency | 1 year | It will be calculated the exacerbation/year-patien rate and will be compared between groups |
| acute exacerbation of chronic obstructive pulmonary disease severity | 1 year | It will be measured the rate of AECOPD with hospitalary and Intensive Care Unity requirement |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| anxiety and depression measures (HAD and Beck Questionnaires) | one year | — |
| echocardiographic parameters | one year | — |
| lymphocyte subpopulations Th-1 and Th-17 | 1 year | It will be measured the lymphocyte subpopulations like Th-1 and Th-17 |
| six-minute walking test | 1 year | — |
| survival | one year | — |
| Maximal inspiratory pressure and maximal expiratory pressure | 1 año | — |
| gas exchange response (carbon and oxygen dioxide arterial pressure) | 1 year | — |
| Health related quality of life | one year | — |
| Forced expiratory volume in first second (FEV1) and forced expiratory capacity | 1 year | — |
| IL-1 and IL-6 cytokines | one year | it will be measured the level of interleukines 1 and 6(IL-1 and IL-6) |
Countries
Mexico
Outcome results
None listed