MedDRA version: 20.0 Level: LLT Classification code 10010953 Term: COPD exacerbation System Organ Class: 100000004855
Conditions
Interventions
Trade Name: SALBUTAMOL ARROW
Product Name: SALBUTAMOL ARROW
Pharmaceutical Form: Nebuliser solution
Trade Name: OXYGENE MEDICINAL LIQUIDE
Product Name: OXYGENE MEDICINAL LIQUIDE
Pharmaceutical Form:
Sponsors
CHU DE POITIERS
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All patients in the Poitiers University Hospital admitted for acute decompensation of chronic obstructive pulmonary disease (COPD, continuous dyspnea asthma) admitted to the medical resuscitation department and Continuing Care Units will be included in the study, They have the following inclusion criteria: - Age = 18 years - Respiratory decompensation with respiratory acidosis (pH> 7.25, FR =65 years) yes F.1.3.1 Number of subjects for this age range 3
Exclusion criteria
Exclusion criteria: All patients will be excluded from the study if one of the following criteria - Age <18 years - Indication to an urgent intubation, - Contra-indication to ß2-mimetics, - Existence of non-respiratory organ failure (hemodynamic failure, neurological failure) - Patients with non-cardio-selective beta-blockers during the study, - Patients not benefiting from a Social Security scheme or not benefiting from it through a third party - Persons benefiting from enhanced protection, ie minors, pregnant women, nursing mothers, persons deprived of their liberty by a judicial or administrative decision, persons staying in a health or social institution, adults under legal protection, and Patients in emergencies. - Pregnant or nursing women, women of childbearing age who do not have effective contraception (hormonal / mechanical: oral, injectable, transcutaneous, implantable, intrauterine device, or surgical: tubal ligation, hysterectomy, total ovariectomy )
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of nebulization of ß2-mimetics by a vibrating membrane device under HDN during the decompensation of COPD.;Secondary Objective: - Evaluate the efficacy of nebulization of ß2-mimetics by a vibrating membrane device (DEP, CV, Rint and P0.1) and the clinic (Borg scale, dyspnea score, respiratory rate, SpO2) Under HDN during the decompensation of COPD - To evaluate the feasibility, tolerance and evolution of hematosis after nebulization of ß2-mimetics administered by high-flow nasal.;Primary end point(s): Evolution of the Maximum Expiratory Volume to the First Second (FEV) between the different times of the study.;Timepoint(s) of evaluation of this end point: 4H15 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Evolution of the clinical data measured during the clinical examination at the different times of the study. - Evolution of hematosis data collected according to a non-invasive transcutaneous method, as performed during the standard monitoring of patients hospitalized in continuing care units or intensive care units. -Evolution of the spirometric data measured at the different times of the study.;Timepoint(s) of evaluation of this end point: 4H15 | — |
Countries
France
Contacts
Public ContactABRIAT FANNY
CHU DE POITIERS
Outcome results
None listed