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CompletedNCT02460614Updated Jun 3, 2015

Effects of Rhinopharyngeal Retrograde Clearance in Children With Acute Viral Bronchiolitis

An interventional study of Rhinopharyngeal clearance and Aspiration in Acute Viral Bronchiolitis, sponsored by Pontificia Universidade Católica do Rio Grande do Sul. Completed. Open to participants aged Up to 12 Months. Per ClinicalTrials.gov, last updated 2015-06-03.

Sponsored by Pontificia Universidade Católica do Rio Grande do Sul · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
Up to 12 Months
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Acute Viral Bronchiolitis

Keywords

  • bronchiolitis
  • respiratory physiotherapy
  • pediatrics
  • rhinopharyngeal clearance
03

Who can participate

Ages eligible
Up to 12 Months
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • acute viral bronchiolitis diagnosis
  • indication for hospital admission

Exclusion criteria

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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
100 participants (actual)

Study arms

  • 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 · Other: 0.9% saline

  • 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 · Other: 0.9% saline

Interventions

  • ProcedureRhinopharyngeal 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.

  • ProcedureAspiration

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

  • Other0.9% saline

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

05

What researchers measure

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

06

Study locations

No study locations are listed for this record.

07

References and documents

Publications

  • 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. PubMed 22499404 ↗
  • 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. Erratum In: Eur J Pediatr. 2012 Mar;171(3):603. PubMed 21927808 ↗
  • 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. PubMed 22281403 ↗
  • 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. PubMed 24271093 ↗
  • 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. PubMed 24333327 ↗
  • 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. PubMed 27555618 ↗
08

Registry details

Key details

Study ID
NCT02460614
Lead sponsor
Pontificia Universidade Católica do Rio Grande do Sul
Responsible party
Marcio Vinicius Fagundes Donadio (Professor, Pontificia Universidade Católica do Rio Grande do Sul) — Principal investigator
First posted
Jun 2, 2015
Start date
Mar 2013
Primary completion
Oct 2013
Completion
Dec 2013
Last update
Jun 3, 2015

Oversight

Data monitoring committee
No
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