Effects of Rhinopharyngeal Retrograde Clearance in Children With Acute Viral Bronchiolitis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2013-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Mucociliary Clearance Techniques for Acute Bronchiolitis

NCT06689631

Acute Bronchiolitis Due to Respiratory Syncytial Virus Bronchiolitis Acute Bronchiolitis Acute Viral

NOT_YET_RECRUITING NA

Respiratory Physical Therapy on the Cardiac Autonomic Modulation Paediatric Patients

NCT01354561

Viral Bronchiolitis

COMPLETED NA

Hypertonic Saline for Acute Bronchiolitis

NCT01247064

Bronchiolitis, Viral Saline Solution, Hypertonic

COMPLETED PHASE4

Effectiveness of the NoseFrida Compared With Bulb Suction at Relieving Objective Signs of Nasal Obstruction and Reducing Return Visits in Pediatric Patients Presenting to the Emergency Department

NCT03666429

Upper Respiratory Tract Infections Nasal Suction Return Emergency Department Visits

WITHDRAWN NA

Nebulised 3% Hypertonic Saline in Infants With Acute Bronchiolitis

NCT06558461

Acute Bronchiolitis

COMPLETED PHASE2/PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Acute Viral Bronchiolitis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Rhinopharyngeal clearance

Intervention Type 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.

0.9% saline

Intervention Type OTHER

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

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.

Group Type ACTIVE_COMPARATOR

Aspiration

Intervention Type PROCEDURE

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

0.9% saline

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type PROCEDURE

Aspiration

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

Intervention Type PROCEDURE

0.9% saline

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Maximum Eligible Age

12 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No