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Effects of Rhinopharyngeal Retrograde Clearance in Children With Acute Viral Bronchiolitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Marcio Vinicius Fagundes Donadio, Pontificia Universidade Católica do Rio Grande do Sul
ClinicalTrials.gov Identifier:
NCT02460614
First received: May 28, 2015
Last updated: June 2, 2015
Last verified: June 2015
  Purpose
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.

Condition Intervention
Acute Viral Bronchiolitis Procedure: Rhinopharyngeal clearance Procedure: Aspiration Other: 0.9% saline

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparison Between Rhinopharyngeal Retrograde Clearance and Nasopharyngeal Aspiration in Children With Acute Viral Bronchiolitis

Further study details as provided by Marcio Vinicius Fagundes Donadio, Pontificia Universidade Católica do Rio Grande do Sul:

Primary Outcome Measures:
  • Occurrence of chest retractions as a measure of respiratory distress [ Time Frame: 30 minutes ]
  • Occurrence of wheezing as a measure of respiratory distress [ Time Frame: 30 minutes ]
  • Number of nasal bleeding events as a measure of adverse effects [ Time Frame: 1 day ]
  • Number of vomit episodes as a measure of adverse effects [ Time Frame: 1 day ]

Secondary Outcome Measures:
  • Measurement of the heart rate using an oximeter [ Time Frame: 30 minutes ]
  • Measurement of the respiratory rate [ Time Frame: 30 minutes ]
  • Measurement of the oxygen saturation using an oximeter [ Time Frame: 30 minutes ]
  • Severity scores on the Wood clinical score [ Time Frame: 30 minutes ]

Enrollment: 100
Study Start Date: March 2013
Study Completion Date: December 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Rhinopharyngeal clearance + 0.9% saline
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
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.
Other: 0.9% saline
0.9% saline consists of physiological solution and was instilled in both experimental groups.
Active Comparator: Aspiration + 0.9% saline
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
A sterile aspiration catheter was connected to an extension and carefully introduced into the nasal cavity of the patient.
Other: 0.9% saline
0.9% saline consists of physiological solution and was instilled in both experimental groups.

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

Ages Eligible for Study:   up to 12 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Marcio Vinicius Fagundes Donadio, Professor, Pontificia Universidade Católica do Rio Grande do Sul
ClinicalTrials.gov Identifier: NCT02460614     History of Changes
Other Study ID Numbers: DRR-15
Study First Received: May 28, 2015
Last Updated: June 2, 2015

Keywords provided by Marcio Vinicius Fagundes Donadio, Pontificia Universidade Católica do Rio Grande do Sul:
bronchiolitis
respiratory physiotherapy
pediatrics
rhinopharyngeal clearance

Additional relevant MeSH terms:
Bronchiolitis
Bronchiolitis, Viral
Bronchitis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections
Virus Diseases

ClinicalTrials.gov processed this record on June 23, 2017