Clinical trial NCT02460614: Effects of Rhinopharyngeal Retrograde Clearance in Children With Acute Viral Bronchiolitis
Official title: Comparison Between Rhinopharyngeal Retrograde Clearance and Nasopharyngeal Aspiration in Children With Acute Viral Bronchiolitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Viral Bronchiolitis
Keywords: bronchiolitis
respiratory physiotherapy
pediatrics
rhinopharyngeal clearance
Lead sponsor: Pontificia Universidade Católica do Rio Grande do Sul
Sponsor class: OTHER
First posted: 2015-06-02
Enrollment: 100
Sex: ALL
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Occurrence of chest retractions as a measure of respiratory distress
timeFrame: 30 minutes
measure: Occurrence of wheezing as a measure of respiratory distress
timeFrame: 30 minutes
measure: Number of nasal bleeding events as a measure of adverse effects
timeFrame: 1 day
measure: Number of vomit episodes as a measure of adverse effects
timeFrame: 1 day
Secondary outcomes:
measure: Measurement of the heart rate using an oximeter
timeFrame: 30 minutes
measure: Measurement of the respiratory rate
timeFrame: 30 minutes
measure: Measurement of the oxygen saturation using an oximeter
timeFrame: 30 minutes
measure: Severity scores on the Wood clinical score
timeFrame: 30 minutes
Other outcomes:
Locations:
Study officials:
References:
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citation: Jarvis K, Pirvu D, Barbee K, Berg N, Meyer M, Gaulke L, Pate BM, Roberts C. Change to a standardized airway clearance protocol for children with bronchiolitis leads to improved care. J Pediatr Nurs. 2014 May-Jun;29(3):252-7. doi: 10.1016/j.pedn.2013.11.007. Epub 2013 Nov 27.
citation: Gomes GR, Calvete FP, Rosito GF, Donadio MV. Rhinopharyngeal Retrograde Clearance Induces Less Respiratory Effort and Fewer Adverse Effects in Comparison With Nasopharyngeal Aspiration in Infants With Acute Viral Bronchiolitis. Respir Care. 2016 Dec;61(12):1613-1619. doi: 10.4187/respcare.04685. Epub 2016 Aug 23.