Effects of Rhinopharyngeal Retrograde Clearance in Children With Acute Viral Bronchiolitis

Pontificia Universidade Católica do Rio Grande do Sul

Status: Completed

Conditions: Acute Viral Bronchiolitis

Treatments: Other: 0.9% saline; Procedure: Aspiration; Procedure: Rhinopharyngeal clearance

Study type: Interventional

Funder types: Other

Identifiers

NCT02460614

DRR-15

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: All

Ages: Under 12 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Rhinopharyngeal clearance + 0.9% saline

Experimental group

Description:

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.

Treatment:

Procedure: Rhinopharyngeal clearance

Other: 0.9% saline

Aspiration + 0.9% saline

Active Comparator group

Description:

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.

Treatment:

Procedure: Aspiration

Other: 0.9% saline