Effects of Rhinopharyngeal Retrograde Clearance in Children With Acute Viral Bronchiolitis

NCT02460614 | Completed

• 1 other identifier: DRR-15
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Acute Viral Bronchiolitis

Keywords

bronchiolitis; respiratory physiotherapy; pediatrics; rhinopharyngeal clearance

Outcome Measures

Primary Outcomes (4)

• Occurrence of chest retractions as a measure of respiratory distress

  30 minutes

• Occurrence of wheezing as a measure of respiratory distress

  30 minutes

• Number of nasal bleeding events as a measure of adverse effects

  1 day

• Number of vomit episodes as a measure of adverse effects

  1 day

Secondary Outcomes (4)

• Measurement of the heart rate using an oximeter

  30 minutes

• Measurement of the respiratory rate

  30 minutes

• Measurement of the oxygen saturation using an oximeter

  30 minutes

• Severity scores on the Wood clinical score

  30 minutes

Study Arms (2)

Rhinopharyngeal clearance + 0.9% saline

EXPERIMENTAL

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; Other: 0.9% saline

Aspiration + 0.9% saline

ACTIVE COMPARATOR

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; Other: 0.9% saline

Interventions

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.

Rhinopharyngeal clearance + 0.9% saline

Aspiration PROCEDURE

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

Aspiration + 0.9% saline

0.9% saline OTHER

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

Aspiration + 0.9% saline; Rhinopharyngeal clearance + 0.9% saline

Eligibility Criteria

• Age: Up to 12 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• acute viral bronchiolitis diagnosis
• indication for hospital admission

You may not qualify if:

• 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

Sponsors & Collaborators

• Pontificia Universidade Católica do Rio Grande do Sul: lead

Related Publications (7)

• Gomes EL, Postiaux G, Medeiros DR, Monteiro KK, Sampaio LM, Costa D. Chest physical therapy is effective in reducing the clinical score in bronchiolitis: randomized controlled trial. Rev Bras Fisioter. 2012 Jun;16(3):241-7. doi: 10.1590/s1413-35552012005000018. Epub 2012 Apr 12.

  PMID: 22499404 BACKGROUND

• Rochat I, Leis P, Bouchardy M, Oberli C, Sourial H, Friedli-Burri M, Perneger T, Barazzone Argiroffo C. Chest physiotherapy using passive expiratory techniques does not reduce bronchiolitis severity: a randomised controlled trial. Eur J Pediatr. 2012 Mar;171(3):457-62. doi: 10.1007/s00431-011-1562-y. Epub 2011 Sep 17.

  PMID: 21927808 BACKGROUND

• Sanchez Bayle M, Martin Martin R, Cano Fernandez J, Martinez Sanchez G, Gomez Martin J, Yep Chullen G, Garcia Garcia MC. [Chest physiotherapy and bronchiolitis in the hospitalised infant. Double-blind clinical trial]. An Pediatr (Barc). 2012 Jul;77(1):5-11. doi: 10.1016/j.anpedi.2011.11.026. Epub 2012 Jan 26. Spanish.

  PMID: 22281403 BACKGROUND

• Jacinto CP, Gastaldi AC, Aguiar DY, Maida KD, Souza HC. Physical therapy for airway clearance improves cardiac autonomic modulation in children with acute bronchiolitis. Braz J Phys Ther. 2013 Nov-Dec;17(6):533-40. doi: 10.1590/S1413-35552012005000120. Epub 2013 Nov 1.

  PMID: 24271093 BACKGROUND

• Jarvis K, Pirvu D, Barbee K, Berg N, Meyer M, Gaulke L, Pate BM, Roberts C. Change to a standardized airway clearance protocol for children with bronchiolitis leads to improved care. J Pediatr Nurs. 2014 May-Jun;29(3):252-7. doi: 10.1016/j.pedn.2013.11.007. Epub 2013 Nov 27.

  PMID: 24333327 BACKGROUND

• Roque-Figuls M, Gine-Garriga M, Granados Rugeles C, Perrotta C, Vilaro J. Chest physiotherapy for acute bronchiolitis in paediatric patients between 0 and 24 months old. Cochrane Database Syst Rev. 2023 Apr 3;4(4):CD004873. doi: 10.1002/14651858.CD004873.pub6.

  PMID: 37010196 DERIVED

• Gomes GR, Calvete FP, Rosito GF, Donadio MV. Rhinopharyngeal Retrograde Clearance Induces Less Respiratory Effort and Fewer Adverse Effects in Comparison With Nasopharyngeal Aspiration in Infants With Acute Viral Bronchiolitis. Respir Care. 2016 Dec;61(12):1613-1619. doi: 10.4187/respcare.04685. Epub 2016 Aug 23.

  PMID: 27555618 DERIVED

MeSH Terms

Conditions

Bronchiolitis

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Bronchitis; Respiratory Tract Infections; Infections; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 28, 2015
• First Posted: June 2, 2015
• Study Start: March 1, 2013
• Primary Completion: October 1, 2013
• Study Completion: December 1, 2013
• Last Updated: June 3, 2015

Record last verified: 2015-06