Effectiveness of nebulization by high nasal flow during acute respiratory decompensations of chronic respiratory insufficiency.
- Conditions
- MedDRA version: 20.0Level: LLTClassification code 10010953Term: COPD exacerbationSystem Organ Class: 100000004855Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
- Registration Number
- EUCTR2017-001579-22-FR
- Lead Sponsor
- CHU DE POITIERS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 25
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 <35, Glasgow 15),
- Indication to a treatment with ß2-mimetic in nebulization,
- Patient capable of answering simple questions despite dyspnea,
- Information given to the patient and collection of consent.
- Free subject, without guardianship or curatorship or subordination
- Patients benefiting from a Social Security scheme or benefiting from it through a third party
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 22
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 3
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 )
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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<br>- 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 Outcome Measures
Name Time Method Secondary end point(s): - Evolution of the clinical data measured during the clinical examination at the different times of the study.<br>- 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.<br>-Evolution of the spirometric data measured at the different times of the study.;Timepoint(s) of evaluation of this end point: 4H15