Clinical trial NCT02458300: Clinical Evaluation of the Response to Chest Physiotherapy in Children With Acute Bronchiolitis
Official title: FIBARRIX "Clinical Evaluation of the Response to Chest Physiotherapy in Infants With Acute Bronchiolitis"
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bronchiolitis
Keywords: Bronchiolitis
Chest
Physical therapy
Lead sponsor: Universidad Católica San Antonio de Murcia
Sponsor class: OTHER
First posted: 2015-06-01
Enrollment: 77
Sex: ALL
Minimum age (years): 1
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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%).

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

Primary outcomes:
measure: Evaluate the effectiveness of a physiotherapy treatment with clinical severity scale of a patient diagnosed with acute viral bronchiolitis
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 7 days
Secondary outcomes:
measure: Assess the variation of score, a scale of severity of acute viral bronchiolitis, after intervention protocols
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 7 days
measure: Analyze a inquiry of subjective opinion, completed by parents or tutors at the end of treatment
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 7 days
measure: To quantify the changes in clinical score severity scale.
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 7 days
Other outcomes:
Locations:
Study officials:
affiliation: MurciaSalud
name: Enrique E Conesa Segura, PT
role: PRINCIPAL_INVESTIGATOR
affiliation: MurciaSalud
name: Susana Beatriz S Reyes Dominguez, PhD,MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidad Católica San Antonio de Murcia
name: José J Rios Diaz, PhD, BiolSc, PT
role: STUDY_CHAIR
affiliation: MurciaSalud
name: Eduardo E Ramos Elbal, MD
role: STUDY_CHAIR
affiliation: MurciaSalud
name: Cristina C Palazón Carpe, MD
role: STUDY_CHAIR
affiliation: MurciaSalud
name: Maria Ángeles M Ruiz Pacheco, MD
role: STUDY_CHAIR
affiliation: MurciaSalud
name: Jaume J Enjuanes Llovet, MD
role: STUDY_CHAIR
affiliation: MurciaSalud
name: Sara S Francés Tarazona, MD
role: STUDY_CHAIR
affiliation: MurciaSalud
name: Sebastián S Gil Garcia, PT
role: STUDY_CHAIR
affiliation: MurciaSalud
name: Maía de los Ángeles M Martinez-Salazar Arboleas, PT
role: STUDY_CHAIR
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