Effects of Rhinopharyngeal Retrograde Clearance in Children With Acute Viral Bronchiolitis

Study Overview
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Brief Summary
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The purpose of this study is to compare the immediate effects of retrograde rhinopharyngeal clearance with nasopharyngeal aspiration in children admitted with acute viral bronchiolitis. The investigators selected children, up to 12 months old, admitted for acute viral bronchiolitis. Patients were divided in aspiration group (AG), submitted to nasopharyngeal aspiration, and clearance group (CG), submitted to retrograde rhinopharyngeal clearance with physiological solution (0.9%) instillation (RRC) technique. In both groups children were evaluated three times in the same day in order to verify cardiorespiratory parameters, clinical score of respiratory dysfunction and adverse effects.

Detailed Description
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Children up to 12 months old, admitted for acute viral acute viral bronchiolitis were selected. All children participating in the study should be in the first 48 hours of hospitalization. Patients were divided in aspiration group (AG), submitted to nasopharyngeal aspiration, and clearance group (CG), submitted to retrograde rhinopharyngeal clearance (RRC) technique with physiological solution (0.9%) instillation. In both groups children were evaluated three times in the same day (data collection 1 (C1) - performed early in the morning; data collecting 2 (C2) - performed in the early afternoon; and data collecting 3 (C3) - performed in the evening). In each data collection, cardiorespiratory parameters and clinical score of respiratory dysfunction were evaluated before procedures (T0), 10 minutes after (T1) and 30 minutes after (T2). Adverse effects were evaluated during the whole day of the study.

Official Title
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Comparison Between Rhinopharyngeal Retrograde Clearance and Nasopharyngeal Aspiration in Children With Acute Viral Bronchiolitis

Conditions
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Acute Viral Bronchiolitis

Intervention / Treatment
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* Procedure: Rhinopharyngeal clearance
* Procedure: Aspiration
* Other: 0.9% saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: acute viral bronchiolitis diagnosis indication for hospital admission Exclusion Criteria: history of lung disease related to prematurity (bronchopulmonary dysplasia) heart diseases chronic lung diseases (cystic fibrosis) pneumonia unstable hemodynamic process (ARDS or sepsis) subcutaneous edema admission to the intensive care unit need for mechanical ventilation or tracheostomy neurological diseases

Ages Eligible for Study
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Maximum Age: 12 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rhinopharyngeal clearance + 0.9% saline<br>The retrograde rhinopharyngeal clearance (RRC) is based on the inspiratory reflex that follows a slow and prolonged expiration (passive exhalation technique performed using a slow thoracic-abdominal compression that begins at the end of a spontaneous exhalation and continues until the expiratory reserve volume). At the end of the expiratory time, the child's mouth was closed by the hand of the researcher (raising the lower jaw), leading the child to perform a nasal aspiration maneuver. The instillation of saline (0.9%) preceded this step, resulting in the inhalation of the substance during the forced inspiration, contributing to the nasopharyngeal clearance. | Procedure: Rhinopharyngeal clearance<br>* At the end of the expiratory time, the child's mouth was closed by the hand of the researcher (raising the lower jaw), leading the child to perform a nasal aspiration maneuver.<br>Other: 0.9% saline<br>* 0.9% saline consists of physiological solution and was instilled in both experimental groups.<br>|
| Active Comparator: Aspiration + 0.9% saline<br>Nasopharyngeal aspiration consisted in the introduction of a catheter that, by using negative pressure (vacuum), promotes the suction of secretion from the airways. In order to do that, a sterile aspiration catheter was connected to an extension and carefully introduced into the nasal cavity of the patient. The saline instillation of 0.9% was used for humidification before the procedure. | Procedure: Aspiration<br>* A sterile aspiration catheter was connected to an extension and carefully introduced into the nasal cavity of the patient.<br>Other: 0.9% saline<br>* 0.9% saline consists of physiological solution and was instilled in both experimental groups.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of chest retractions as a measure of respiratory distress |  | 30 minutes | 
| Occurrence of wheezing as a measure of respiratory distress |  | 30 minutes | 
| Number of nasal bleeding events as a measure of adverse effects |  | 1 day | 
| Number of vomit episodes as a measure of adverse effects |  | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of the heart rate using an oximeter |  | 30 minutes | 
| Measurement of the respiratory rate |  | 30 minutes | 
| Measurement of the oxygen saturation using an oximeter |  | 30 minutes | 
| Severity scores on the Wood clinical score |  | 30 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bronchiolitis, respiratory physiotherapy, pediatrics, rhinopharyngeal clearance