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Effects of Rhinopharyngeal Retrograde Clearance in Children With Acute Viral Bronchiolitis

Primary Purpose

Acute Viral Bronchiolitis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Rhinopharyngeal clearance
Aspiration
0.9% saline
Sponsored by
Pontificia Universidade Católica do Rio Grande do Sul
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Viral Bronchiolitis focused on measuring bronchiolitis, respiratory physiotherapy, pediatrics, rhinopharyngeal clearance

Eligibility Criteria

undefined - 12 Months (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Rhinopharyngeal clearance + 0.9% saline

    Aspiration + 0.9% saline

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Occurrence of chest retractions as a measure of respiratory distress
    Occurrence of wheezing as a measure of respiratory distress
    Number of nasal bleeding events as a measure of adverse effects
    Number of vomit episodes as a measure of adverse effects

    Secondary Outcome Measures

    Measurement of the heart rate using an oximeter
    Measurement of the respiratory rate
    Measurement of the oxygen saturation using an oximeter
    Severity scores on the Wood clinical score

    Full Information

    First Posted
    May 28, 2015
    Last Updated
    June 2, 2015
    Sponsor
    Pontificia Universidade Católica do Rio Grande do Sul
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02460614
    Brief Title
    Effects of Rhinopharyngeal Retrograde Clearance in Children With Acute Viral Bronchiolitis
    Official Title
    Comparison Between Rhinopharyngeal Retrograde Clearance and Nasopharyngeal Aspiration in Children With Acute Viral Bronchiolitis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2013 (undefined)
    Primary Completion Date
    October 2013 (Actual)
    Study Completion Date
    December 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Pontificia Universidade Católica do Rio Grande do Sul

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Acute Viral Bronchiolitis
    Keywords
    bronchiolitis, respiratory physiotherapy, pediatrics, rhinopharyngeal clearance

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    100 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Rhinopharyngeal clearance + 0.9% saline
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Aspiration + 0.9% saline
    Arm Type
    Active Comparator
    Arm Description
    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.
    Intervention Type
    Procedure
    Intervention Name(s)
    Rhinopharyngeal clearance
    Intervention Description
    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
    Intervention Name(s)
    Aspiration
    Intervention Description
    A sterile aspiration catheter was connected to an extension and carefully introduced into the nasal cavity of the patient.
    Intervention Type
    Other
    Intervention Name(s)
    0.9% saline
    Intervention Description
    0.9% saline consists of physiological solution and was instilled in both experimental groups.
    Primary Outcome Measure Information:
    Title
    Occurrence of chest retractions as a measure of respiratory distress
    Time Frame
    30 minutes
    Title
    Occurrence of wheezing as a measure of respiratory distress
    Time Frame
    30 minutes
    Title
    Number of nasal bleeding events as a measure of adverse effects
    Time Frame
    1 day
    Title
    Number of vomit episodes as a measure of adverse effects
    Time Frame
    1 day
    Secondary Outcome Measure Information:
    Title
    Measurement of the heart rate using an oximeter
    Time Frame
    30 minutes
    Title
    Measurement of the respiratory rate
    Time Frame
    30 minutes
    Title
    Measurement of the oxygen saturation using an oximeter
    Time Frame
    30 minutes
    Title
    Severity scores on the Wood clinical score
    Time Frame
    30 minutes

    10. Eligibility

    Sex
    All
    Maximum Age & Unit of Time
    12 Months
    Accepts Healthy Volunteers
    No
    Eligibility 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

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    22499404
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    21927808
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    22281403
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    24271093
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    24333327
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    27555618
    Citation
    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.
    Results Reference
    derived

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    Effects of Rhinopharyngeal Retrograde Clearance in Children With Acute Viral Bronchiolitis

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