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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02458300
First Posted: June 1, 2015
Last Update Posted: March 2, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Enrique Conesa Segura, Universidad Católica San Antonio de Murcia
  Purpose
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.

Condition Intervention
Bronchiolitis Other: Nebulization of hypertonic saline Other: Prolonged slow expiration technique (PSE) Other: Patient coughing Provocation (TP) Other: inspiratory maneuver to rhinopharyngeal cleaning DRR Other: Aspiration of secretions

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: FIBARRIX "Clinical Evaluation of the Response to Chest Physiotherapy in Infants With Acute Bronchiolitis"

Further study details as provided by Enrique Conesa Segura, Universidad Católica San Antonio de Murcia:

Primary Outcome Measures:
  • 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 Measures:
  • 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 ]
  • Analyze a inquiry of subjective opinion, completed by parents or tutors at the end of treatment [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 7 days ]
    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. [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 7 days ]

Enrollment: 77
Study Start Date: January 2015
Study Completion Date: March 2015
Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Control Arm
Nebulized hypertonic saline. Aspiration of secretions
Other: Nebulization of hypertonic saline
application of hypertonic saline serum through a mask fogging or a box fogging
Other: Aspiration of secretions
Suctioning with a probe by a vacuum system installed on the wall.
Active Comparator: Intervention Arm.
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
Other: Nebulization of hypertonic saline
application of hypertonic saline serum through a mask fogging or a box fogging
Other: Prolonged slow expiration technique (PSE)
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.
Other: Patient coughing Provocation (TP)
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.
Other: inspiratory maneuver to rhinopharyngeal cleaning DRR
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
Other: Aspiration of secretions
Suctioning with a probe by a vacuum system installed on the wall.

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%).

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Month to 2 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02458300


Sponsors and Collaborators
Universidad Católica San Antonio de Murcia
Investigators
Principal Investigator: Enrique E Conesa Segura, PT MurciaSalud
Principal Investigator: Susana Beatriz S Reyes Dominguez, PhD,MD MurciaSalud
Study Chair: José J Rios Diaz, PhD, BiolSc, PT Universidad Católica San Antonio de Murcia
Study Chair: Eduardo E Ramos Elbal, MD MurciaSalud
Study Chair: Cristina C Palazón Carpe, MD MurciaSalud
Study Chair: Maria Ángeles M Ruiz Pacheco, MD MurciaSalud
Study Chair: Jaume J Enjuanes Llovet, MD MurciaSalud
Study Chair: Sara S Francés Tarazona, MD MurciaSalud
Study Chair: Sebastián S Gil Garcia, PT MurciaSalud
Study Chair: Maía de los Ángeles M Martinez-Salazar Arboleas, PT MurciaSalud
  More Information

Publications:

Responsible Party: Enrique Conesa Segura, PT, Universidad Católica San Antonio de Murcia
ClinicalTrials.gov Identifier: NCT02458300     History of Changes
Other Study ID Numbers: FIBARRIX
First Submitted: May 20, 2015
First Posted: June 1, 2015
Last Update Posted: March 2, 2016
Last Verified: May 2015
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Enrique Conesa Segura, Universidad Católica San Antonio de Murcia:
Bronchiolitis
Chest
Physical therapy

Additional relevant MeSH terms:
Bronchiolitis
Bronchitis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections