Chronic Respiratory Failure
Conditions
Brief summary
randomized double-blind controlled study in parallel groups Salbutamol is a β2 mimetic short-acting to be administered by nebulization in this study. During this administration, non invasive ventilation for the patient will be continued.
Detailed description
Randomization will focus on the treatment administered (placebo or salbutamol ). After the first phase , a switch will be set up for each patient , retaining the blind it will be administered salbutamol (for those who received placebo in the first phase ) or placebo (for those receiving salbutamol ) .
Interventions
DRUGSalbutamol
First administration of salbutamol or placebo at M0 and 2nd salbutamol or placebo at M60 (or M0 + 60 minutes)
DRUGPlacebo
First administration of salbutamol or placebo at M0 and 2nd salbutamol or placebo at M60 (or M0 + 60 minutes)
Sponsors
University Hospital, Tours
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient over 18 years old * Patient with BPCO, defined: * by an irreversible obstructive syndrome * and\\or by different arguments (histories, symptoms, physical examination, thoracic radiography, gas of the blood) * Decompensation of this BPCO in the form of acute respiratory failure * No argument for a dominant acute left cardiac insufficiency * Consent signed by the patient * Patient with national health assurance
Exclusion criteria
* Contraindications in the not invasive ventilation * Patient not volunteer for the realization of the spirometry * Precautions for use of ß2 mimetic (engrave hyperthyroidism) * Under guardianship patient or protection of justice * Pregnant patient
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Collection at the bedside spirometric values | gross change in forced expiratory volume in one second from the beginning of salbutamol or placebo and 15 min after the start |
Secondary
| Measure | Time frame |
|---|---|
| gross change in vital capacity of peak expiratory flow rate, the ratio of FEV, forced expiratory flow | between the median baseline and 15 min after the start of treatment |
| gross change in respiratory rate, heart rate and systolic and diastolic blood pressure | between baseline and 15 min after the start of treatment |
| gross change in dyspnea | between baseline and 15 min after the start of treatment |
Countries
France
Outcome results
None listed