The Effectiveness of AAD and IPV to Treat Hospitalized Infants (<2years) With Acute Viral Bronchiolitis.

Study Overview
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Brief Summary
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The purpose of this study is to investigate the effectiveness of two airway clearance techniques; Intrapulmonary Percussive Ventilation and Assisted Autogenic Drainage in hospitalized infants under the age of 2 with acute viral bronchiolitis.

Official Title
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The Effectiveness of Assisted Autogenic Drainage (AAD) and Intrapulmonary Percussive Ventilation (IPV) to Treat Hospitalized Infants (<2years) With Acute Viral Bronchiolitis: a Randomised Clinical Trial.

Conditions
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Bronchiolitis

Intervention / Treatment
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* Other: inhalation 4ml hypertonic saline 3% 3x/day
* Device: Intrapulmonary Percussive Ventilation
* Procedure: Assisted Autogenic Drainage


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: first period of wheezing Wang score between 3 and 7 age < 24 months Sa02> 90% Exclusion Criteria: ICU patients mechanical ventilation use of antibiotics use of corticosteroids gestational age < 34 weeks chronic cardiac or pulmonary disease no parental consent

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 24 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intrapulmonary Percussive Ventilation<br>20 min of IPV administered to the patient inhalation 4ml hypertonic saline 3% 3x/day | Other: inhalation 4ml hypertonic saline 3% 3x/day<br> <br> Device: Intrapulmonary Percussive Ventilation<br> <br> |
| Active Comparator: Assisted Autogenic Drainage<br>20 min of AAD administered to the patient inhalation 4ml hypertonic saline 3% 3x/day | Other: inhalation 4ml hypertonic saline 3% 3x/day<br> <br> Procedure: Assisted Autogenic Drainage<br> <br> |
| No Intervention: control<br>20 min of bouncing administered tot the patient inhalation 4ml hypertonic saline 3% 3x/day | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of Hospital Stay | Previously publised data ( Luo et al. 2011) showed that the average hospital stay for infants with acute viral bronchiolitis, inhaling 4 ml NaCl3%, three times /day is 6 days ( SD 1,2) | 6 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wang Score |  | before treatment, immediately after treatment and 1h after treatment | 
| Heartrate |  | before, after and 1h after intervention | 
| Oxygen Saturation (SaO2) | oxygen saturation (SaO2) measured by pulse -oximetry | before, after and 1h after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bronchiolitis, Wang score, Sa02, airway clearance techniques, intrapulmonary percussive ventilation, assisted autogenic drainage