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NCT Number: NCT02460614

Effects of Rhinopharyngeal Retrograde Clearance in Children With Acute Viral Bronchiolitis

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.

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Key information

Age range

Up to 12 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rhinopharyngeal clearance

Procedure

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.

Aspiration

Procedure

A sterile aspiration catheter was connected to an extension and carefully introduced into the nasal cavity of the patient.

0.9% saline

Other

0.9% saline consists of physiological solution and was instilled in both experimental groups.

Primary outcomes

  1. Occurrence of chest retractions as a measure of respiratory distress

    Time frame: 30 minutes

  2. Occurrence of wheezing as a measure of respiratory distress

    Time frame: 30 minutes

  3. Number of nasal bleeding events as a measure of adverse effects

    Time frame: 1 day

  4. Number of vomit episodes as a measure of adverse effects

    Time frame: 1 day

Secondary outcomes

  1. Measurement of the heart rate using an oximeter

    Time frame: 30 minutes

  2. Measurement of the respiratory rate

    Time frame: 30 minutes

  3. Measurement of the oxygen saturation using an oximeter

    Time frame: 30 minutes

  4. Severity scores on the Wood clinical score

    Time frame: 30 minutes

Sponsors and collaborators

Lead sponsor

Pontificia Universidade Católica do Rio Grande do Sul

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Jun 2, 2015
Registry last updated
Jun 3, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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