Asthma
Conditions
Keywords
nebulizer, PARI LC Spring SP
Brief summary
The main objective of this study is to determine whether the use of the PARI LC Sprint Sp nebulizer in the treatment of asthma in children under 36 months reduces the duration of hospitalization.
Detailed description
The secondary objectives of this study are to evaluate whether the use of the LC Sprint Sp Nebulizer results in: A-shortened duration of oxygen-dependence. B-reduced side effects by assessing the patient's heart rate before and 30 minutes after the first aerosol and noting the occurrence of desaturation \<90% during the nebulisation sessions. C-increased acceptance of the aerosol, measured via a questionnaire given to the patient's parents at the end of hospitalization (a single questionnaire will be completed by either parent or both parents). D-shortened length of stay based on the following discharge criteria: observation of a respiratory severity score ≤ 2 (Clinical Asthma Score (CAS)) for at least 12 consecutive hours and a transcutaneous oxygen saturation (SpO2)\> 94% when awake or \> 91% during sleep.
Interventions
DEVICEStandard nebulizer
Nebulizer sessions for the patients will be administerd using our standard nebulizer: Micro Mist, ref 41894, Hudson RCI, distributed by Téléflex Médical.
DEVICEPARI LC Sprint Sp nebulizer
Nebulizer sessions for the patients will be administerd using the PARI LC Sprint Sp nebulizer. Manufacturer: PARI GmbH Germany
Sponsors
Centre Hospitalier Universitaire de Nīmes
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Months to 36 Months
Healthy volunteers
No
Inclusion criteria
* The parent or legal representative must have given his/her informed and signed consent * The patient must be insured or beneficiary of a health insurance plan * The patient has an attack of moderate to severe asthma (at least the third episode of wheezing dyspnea since birth) requiring hospitalization defined by the following criteria: * requires oxygen: SpO2 \<92% on room air (if CAS ≤ 4/10) * And / or CAS\> 4/10 (after 3 attempted nebulized salbutamol sessions over 1 hour of emergency care).
Exclusion criteria
* The patient is participating in another study * The patients has already been included in this study a previous time * The patient is in an exclusion period determined by a previous study * The patient is under judicial protection, under tutorship or curatorship * The parent or legal representative refuses to sign the consent * It is impossible to correctly inform the parent or legal representative * The patient has a contra indication for a treatement used in this study * Patient was born at \< 34 weeks of pregnancy or bronchdysplasic * First or second episode of bronchiolitis * Asthma attack with CAS score ≤ 4/10 or inpatient basis for a non-breathing related motive. * Acute severe Asthma attack: hypercapnia, impaired consciousness, need for hospitalization in intensive care, need for mechanical ventilation, need for salbutamol IV * Patient with known congenital heart disease * Patient with chronic respiratory disease other than asthma * Patient with encephalopathy * Patient with known immune deficiency * CAS ≤ 2 and transcutaneous oxygen saturation (SpO2)\> 94% when awake or \> 91% when asleep for at least 12h
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Length of hospitalization | hospital discharge (maximum of 10 days) | The length of hospitalization in days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Heart rate before the first nebulisation session | Day 0 | Heart rate before the first nebulisation session (bpm) |
| Heart rate 30 minutes after the first nebulisation session | Day 0 | Heart rate 30 minutes after the first nebulisation session (bpm) |
| Duration of oxygen therapy | Day 0 | Duration of oxygen therapy (necessary to return to a saturation of \> 91% when sleep, or \> 94% when awake); measured in hours |
| Parent estimated tolerance | Hospital discharge (maximum 10 days) | A visual analog scale is used to evaluate how parents estimate aerosol tolerance. |
| Length of hospitalization according to discharge criteria | Hospital discharge (maximum 10 days) | length of stay based on the following discharge criteria: observation of a respiratory severity score ≤ 2 (Clinical Asthma Score CAS) for at least 12 consecutive hours and a transcutaneous oxygen saturation (SpO2)\> 94% when awake or \> 91% during sleep |
| SpO2 saturation less thant 90% during or after nebulisation session? | Day 0 | Does the SpO2 saturation drop to less thant 90% during or after nebulisation session? (up to 30 minutes after the session; yes/no) |
Countries
France
Outcome results
None listed