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Clinical Evaluation of the Response to Chest Physiotherapy in Children With Acute Bronchiolitis (FIBARRIX)

Primary Purpose

Bronchiolitis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Nebulization of hypertonic saline
Prolonged slow expiration technique (PSE)
Patient coughing Provocation (TP)
inspiratory maneuver to rhinopharyngeal cleaning DRR
Aspiration of secretions
Sponsored by
Universidad Católica San Antonio de Murcia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bronchiolitis focused on measuring Bronchiolitis, Chest, Physical therapy

Eligibility Criteria

1 Month - 2 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients admitted to the pediatric intensive care unit or pediatric nursing unit. Which they are diagnostic of acute viral bronchiolitis (AVB).

Exclusion Criteria:

  • Presence of cyanotic congenital heart disease no longer for comparing the constants.
  • Relative or absolute contraindication CPT techniques included in the protocol.

    • Patients diagnosed with moderate or severe gastroesophageal reflux since the PSE gastroesophageal reflux can accentuate a previously exist.
    • Patients with laryngeal diseases caused because the cough is a technique that is applied directly to the tracheal wall and can affect the larynx.
    • Absence of cough reflects and presence of laryngeal stridor is a contraindication to chest physiotherapy in general.
    • Systematic presence of gag reflex as the aspiration of secretions and coughing caused nasobucales stimulate this reflex

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Placebo Comparator

    Active Comparator

    Arm Label

    Control Arm

    Intervention Arm.

    Arm Description

    Nebulized hypertonic saline. Aspiration of secretions

    Nebulization of hypertonic saline. Application of Prolonged slow expiration technique (PSE) expiratory volume. Patient coughing Provocation (TP) Inspiratory maneuver to rhinopharyngeal cleaning DRR Aspiration of secretions

    Outcomes

    Primary Outcome Measures

    Evaluate the effectiveness of a physiotherapy treatment with clinical severity scale of a patient diagnosed with acute viral bronchiolitis

    Secondary Outcome Measures

    Assess the variation of score, a scale of severity of acute viral bronchiolitis, after intervention protocols
    Analyze a inquiry of subjective opinion, completed by parents or tutors at the end of treatment
    A questionnaire was filled out by parents or guardians of patients. After, the results of the survey will be analyzed by means of SPSS software
    To quantify the changes in clinical score severity scale.

    Full Information

    First Posted
    May 20, 2015
    Last Updated
    March 1, 2016
    Sponsor
    Universidad Católica San Antonio de Murcia
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02458300
    Brief Title
    Clinical Evaluation of the Response to Chest Physiotherapy in Children With Acute Bronchiolitis
    Acronym
    FIBARRIX
    Official Title
    FIBARRIX "Clinical Evaluation of the Response to Chest Physiotherapy in Infants With Acute Bronchiolitis"
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2015 (undefined)
    Primary Completion Date
    March 2015 (Actual)
    Study Completion Date
    March 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Universidad Católica San Antonio de Murcia

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The objective of this study is to evaluate the clinical response of children diagnosed with acute bronchiolitis, relative to a chest physiotherapy protocol. Comparing this treatment with standard care of the nursing staff and auxiliaries of infants patients aged 1 month to 2 years.
    Detailed Description
    This randomized clinical trial has an intervention group and a control group. All treatment will be made by physiotherapist with extensive clinical experience and training in techniques of Chest physiotherapy (CPT). Performing at least one session per day during the time of patient admission. This session takes an average of about 15 minutes, begins by fogging of hypertonic saline, and ends with the nasal and oral suction of the patient. The evaluation of clinical data is done 10 minutes before, 10 minutes later, 2 hours after physiotherapy treatment. The evaluation will be do it for a doctor who will, in all patients, a clinical examination that includes all items scale clinical severity of acute bronchiolitis. Patient Registries: SELECTION OF THE POPULATION Reference population. Patients diagnosed acute viral bronchiolitis during the conduct of the trial and have been admitted to the University Hospital Virgin of Arrixaca. Sample size The sample calculation was done considering a reduction of 2 points after physiotherapy in bronchiolitis severity scale. Whereas: Variances: sames Detect mean difference: 2,000 Common standard deviation: 2,370 Ratio of sample sizes: 1,00 Confidence level: 95,0% The standard deviation values were obtained from: JM Fernández Ramos et al Validation of a clinical scale of severity of acute bronchiolitis. An Pediatr (Barc). 2014; 81 (1): 3-8, article in which the mean and standard deviation (SD) score of patients admitted was 7 ± 2.37. There are no items to compare this scale before and after treatment, so the investigators have assumed that value of common standard deviation (SD) and whereas a decrease of 2 points on the scale post-physical therapy would be clinically relevant. Power (%) Sample size Cases Control Total 85,0 27 27 54 90 31 31 62 Finally it was decided to increase to 60 cases / group considering that the number of losses may be higher (the investigators calculate 50%).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Bronchiolitis
    Keywords
    Bronchiolitis, Chest, Physical therapy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    77 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Control Arm
    Arm Type
    Placebo Comparator
    Arm Description
    Nebulized hypertonic saline. Aspiration of secretions
    Arm Title
    Intervention Arm.
    Arm Type
    Active Comparator
    Arm Description
    Nebulization of hypertonic saline. Application of Prolonged slow expiration technique (PSE) expiratory volume. Patient coughing Provocation (TP) Inspiratory maneuver to rhinopharyngeal cleaning DRR Aspiration of secretions
    Intervention Type
    Other
    Intervention Name(s)
    Nebulization of hypertonic saline
    Intervention Description
    application of hypertonic saline serum through a mask fogging or a box fogging
    Intervention Type
    Other
    Intervention Name(s)
    Prolonged slow expiration technique (PSE)
    Intervention Description
    Passive expiratory aid implemented baby. the child is placed supine on a hard surface. Thoracoabdominal slow manual pressure that begins at the end of a spontaneous and continuous exhalation to residual volume is exercised. Oppose reaches 2 or 3 breaths. Vibrations can accompany the art. The goal is to achieve a greater expiratory volume.
    Intervention Type
    Other
    Intervention Name(s)
    Patient coughing Provocation (TP)
    Intervention Description
    Tp is based on the mechanism reflects cough induced by stimulation of the buttons on the wall of the trachea extrathoracic mechanoreceptors. The child is placed supine. A short pressure is done with the thumb on the tracheal conduit (in the sternal notch) at the end of inspiration, or at the beginning of expiration. With the other hand holding the abdominal region we prevent the dissipation of energy and make the explosion tussive more effective. It is done after the PSE.
    Intervention Type
    Other
    Intervention Name(s)
    inspiratory maneuver to rhinopharyngeal cleaning DRR
    Intervention Description
    After the inspiratory reflection following the PSE, the TP or crying. At the end of expiratory time the child's mouth is closed with the back of his hand just finished his chest support, raising the jaw and forcing the child to an inspiration with the nose
    Intervention Type
    Other
    Intervention Name(s)
    Aspiration of secretions
    Intervention Description
    Suctioning with a probe by a vacuum system installed on the wall.
    Primary Outcome Measure Information:
    Title
    Evaluate the effectiveness of a physiotherapy treatment with clinical severity scale of a patient diagnosed with acute viral bronchiolitis
    Time Frame
    Participants will be followed for the duration of hospital stay, an expected average of 7 days
    Secondary Outcome Measure Information:
    Title
    Assess the variation of score, a scale of severity of acute viral bronchiolitis, after intervention protocols
    Time Frame
    Participants will be followed for the duration of hospital stay, an expected average of 7 days
    Title
    Analyze a inquiry of subjective opinion, completed by parents or tutors at the end of treatment
    Description
    A questionnaire was filled out by parents or guardians of patients. After, the results of the survey will be analyzed by means of SPSS software
    Time Frame
    Participants will be followed for the duration of hospital stay, an expected average of 7 days
    Title
    To quantify the changes in clinical score severity scale.
    Time Frame
    Participants will be followed for the duration of hospital stay, an expected average of 7 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    1 Month
    Maximum Age & Unit of Time
    2 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients admitted to the pediatric intensive care unit or pediatric nursing unit. Which they are diagnostic of acute viral bronchiolitis (AVB). Exclusion Criteria: Presence of cyanotic congenital heart disease no longer for comparing the constants. Relative or absolute contraindication CPT techniques included in the protocol. Patients diagnosed with moderate or severe gastroesophageal reflux since the PSE gastroesophageal reflux can accentuate a previously exist. Patients with laryngeal diseases caused because the cough is a technique that is applied directly to the tracheal wall and can affect the larynx. Absence of cough reflects and presence of laryngeal stridor is a contraindication to chest physiotherapy in general. Systematic presence of gag reflex as the aspiration of secretions and coughing caused nasobucales stimulate this reflex
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Enrique E Conesa Segura, PT
    Organizational Affiliation
    MurciaSalud
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Susana Beatriz S Reyes Dominguez, PhD,MD
    Organizational Affiliation
    MurciaSalud
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    José J Rios Diaz, PhD, BiolSc, PT
    Organizational Affiliation
    Universidad Católica San Antonio de Murcia
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Eduardo E Ramos Elbal, MD
    Organizational Affiliation
    MurciaSalud
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Cristina C Palazón Carpe, MD
    Organizational Affiliation
    MurciaSalud
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Maria Ángeles M Ruiz Pacheco, MD
    Organizational Affiliation
    MurciaSalud
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Jaume J Enjuanes Llovet, MD
    Organizational Affiliation
    MurciaSalud
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Sara S Francés Tarazona, MD
    Organizational Affiliation
    MurciaSalud
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Sebastián S Gil Garcia, PT
    Organizational Affiliation
    MurciaSalud
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Maía de los Ángeles M Martinez-Salazar Arboleas, PT
    Organizational Affiliation
    MurciaSalud
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
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    Clinical Evaluation of the Response to Chest Physiotherapy in Children With Acute Bronchiolitis

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