Beta Agonist Nebulization in Non Invasively Ventilated COPD Patients: Safety, and Therapeutic Efficacy Range.
- Registration Number
- NCT01958814
- Lead Sponsor
- University Hospital, Tours
- 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 ) .
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 43
-
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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Salbutamol - Placebo Salbutamol salbutamol at M0 and M60 placebo administration Placebo - Salbutamol Placebo placebo at M0 and M60 salbutamol administration Salbutamol - Placebo Placebo salbutamol at M0 and M60 placebo administration Placebo - Salbutamol Salbutamol placebo at M0 and M60 salbutamol administration
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (3)
Service de Réanimation Médicale - CHR d'Orléans
🇫🇷Orléans, France
Service de Réanimation
🇫🇷Poitiers, France
CHRU de Tours
🇫🇷Tours, France