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

March 1, 2016 updated by: Enrique Conesa Segura, Universidad Católica San Antonio de Murcia

FIBARRIX "Clinical Evaluation of the Response to Chest Physiotherapy in Infants With Acute Bronchiolitis"

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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%).

Study Type

Interventional

Enrollment (Actual)

77

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 2 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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: Aspiration of secretions
Suctioning with a probe by a vacuum system installed on the wall.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Participants will be followed for the duration of hospital stay, an expected average of 7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
Participants will be followed for the duration of hospital stay, an expected average of 7 days
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
Participants will be followed for the duration of hospital stay, an expected average of 7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Actual)

March 1, 2015

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

May 20, 2015

First Submitted That Met QC Criteria

May 27, 2015

First Posted (Estimate)

June 1, 2015

Study Record Updates

Last Update Posted (Estimate)

March 2, 2016

Last Update Submitted That Met QC Criteria

March 1, 2016

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FIBARRIX

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Bronchiolitis

Clinical Trials on Nebulization of hypertonic saline

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Taiwan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe