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

Universidad Católica San Antonio de Murcia

Status: Completed

Conditions: Bronchiolitis

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

Study type: Interventional

Funder types: Other

Identifiers

NCT02458300

FIBARRIX

Details and patient eligibility

About

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.

Full 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%).

Enrollment: 77 patients

Sex: All

Ages: 1 month to 2 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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77 participants in 2 patient groups, including a placebo group

Control Arm

Placebo Comparator group

Description:

Nebulized hypertonic saline. Aspiration of secretions

Treatment:

Other: Nebulization of hypertonic saline

Other: Aspiration of secretions

Intervention Arm.

Active Comparator group

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

Treatment:

Other: inspiratory maneuver to rhinopharyngeal cleaning DRR

Other: Nebulization of hypertonic saline

Other: Patient coughing Provocation (TP)

Other: Aspiration of secretions

Other: Prolonged slow expiration technique (PSE)