Efficacy of the PARI LC Sprint Sp Nebulizer for Acute Asthma Attack in Hospitalized Children Less Than 36 Months of Age
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Length of hospitalization
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Months 至 36 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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
研究组 & 干预措施
Standard nubulizer
Nebulizer sessions for the patients in this arm will be administerd using our "standard" nebulizer: Micro Mist, ref 41894, Hudson RCI, distributed by Téléflex Médical.
干预措施: Standard nebulizer (Device)
Experimental nebulizer
Nebulizer sessions for the patients in this arm will be administerd using the PARI LC Sprint Sp nebulizer.
Manufacturer: PARI GmbH Germany
干预措施: PARI LC Sprint Sp nebulizer (Device)
结局指标
主要结局
Length of hospitalization
时间窗: hospital discharge (maximum of 10 days)
The length of hospitalization in days
次要结局
- Heart rate 30 minutes after the first nebulisation session(Day 10)
- Parent estimated tolerance(Hospital discharge (maximum 10 days))
- Length of hospitalization according to discharge criteria(Hospital discharge (maximum 10 days))
- Duration of oxygen therapy(Day 10)
- Heart rate before the first nebulisation session(Day 10)
- SpO2 saturation less thant 90% during or after nebulisation session?(Day 10)
- Duration of oxygen therapy(Day 0)
- Heart rate before the first nebulisation session(Day 0)
- Heart rate 30 minutes after the first nebulisation session(Day 0)
- SpO2 saturation less thant 90% during or after nebulisation session?(Day 0)
- Duration of oxygen therapy(Day 1)
- Duration of oxygen therapy(Day 2)
- Duration of oxygen therapy(Day 3)
- Duration of oxygen therapy(Day 4)
- Duration of oxygen therapy(Day 5)
- Duration of oxygen therapy(Day 6)
- Duration of oxygen therapy(Day 7)
- Duration of oxygen therapy(Day 8)
- Duration of oxygen therapy(Day 9)
- Heart rate before the first nebulisation session(Day 1)
- Heart rate before the first nebulisation session(Day 2)
- Heart rate before the first nebulisation session(Day 3)
- Heart rate before the first nebulisation session(Day 4)
- Heart rate before the first nebulisation session(Day 5)
- Heart rate before the first nebulisation session(Day 6)
- Heart rate before the first nebulisation session(Day 7)
- Heart rate before the first nebulisation session(Day 8)
- Heart rate before the first nebulisation session(Day 9)
- Heart rate 30 minutes after the first nebulisation session(Day 1)
- Heart rate 30 minutes after the first nebulisation session(Day 2)
- Heart rate 30 minutes after the first nebulisation session(Day 3)
- Heart rate 30 minutes after the first nebulisation session(Day 4)
- Heart rate 30 minutes after the first nebulisation session(Day 5)
- Heart rate 30 minutes after the first nebulisation session(Day 6)
- Heart rate 30 minutes after the first nebulisation session(Day 7)
- Heart rate 30 minutes after the first nebulisation session(Day 8)
- Heart rate 30 minutes after the first nebulisation session(Day 9)
- SpO2 saturation less thant 90% during or after nebulisation session?(Day 1)
- SpO2 saturation less thant 90% during or after nebulisation session?(Day 2)
- SpO2 saturation less thant 90% during or after nebulisation session?(Day 3)
- SpO2 saturation less thant 90% during or after nebulisation session?(Day 4)
- SpO2 saturation less thant 90% during or after nebulisation session?(Day 5)
- SpO2 saturation less thant 90% during or after nebulisation session?(Day 6)
- SpO2 saturation less thant 90% during or after nebulisation session?(Day 7)
- SpO2 saturation less thant 90% during or after nebulisation session?(Day 8)
- SpO2 saturation less thant 90% during or after nebulisation session?(Day 9)