Effects of Rhinopharyngeal Retrograde Clearance in Children With Acute Viral Bronchiolitis

June 2, 2015 updated by: Marcio Vinicius Fagundes Donadio, Pontificia Universidade Católica do Rio Grande do Sul

Comparison Between Rhinopharyngeal Retrograde Clearance and Nasopharyngeal Aspiration 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 1 year (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Other: 0.9% saline
0.9% saline consists of physiological solution and was instilled in both experimental groups.
Procedure: Aspiration
A sterile aspiration catheter was connected to an extension and carefully introduced into the nasal cavity of the patient.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pontificia Universidade Católica do Rio Grande do Sul

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (Actual)

October 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

May 28, 2015

First Submitted That Met QC Criteria

May 29, 2015

First Posted (Estimate)

June 2, 2015

Study Record Updates

Last Update Posted (Estimate)

June 3, 2015

Last Update Submitted That Met QC Criteria

June 2, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DRR-15

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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