Mucociliary Clearance Techniques in Moderate Bronchiolitis

Summary

Acute viral bronchiolitis (BE) is an inflammatory disease of the lower respiratory tract, with a viral etiology, where the respiratory syncytial virus is the most prevalent agent. Respiratory physiotherapy (FTR) aims to remove airway obstruction, which decreases airway resistance, improves gas exchange, and reduces respiratory load. It is widely used in the treatment of children with chronic respiratory disease, but has long been debated as a treatment for bronchiolitis.

The objective of this study is to evaluate the effectiveness of two mucociliary clearance techniques in non-hospitalized children \<12 months with a first episode of moderate BE.

This is a clinical trial that aims to recruit patients from 2 to 12 months who attend the Physiobronchial physiotherapy centers in Madrid, A Coruña, and Barcelona with a first-time medical diagnosis of BQ of 48 hours of maximum evolution. Participants will be randomly assigned into 3 groups: Group A: Assisted Autogenous Drainage (DAA), Group B: Prolonged Slow Expiration (ELPr) and Control Group. The main variables are the Acute Bronchiolitis Severity Scale (ESBA), oxygen saturation (SaO2), the modified Wood-Downes scale (WD-S), the Hospital scale Sant Joan de Déu (HSJD) and the ReSVinet Scale (RSV-S), and will be measured by a blinded evaluator at the beginning of the session (T0), 20 minutes after administering short-acting β2 adrenergic agonist (SABA) (T20 ), immediately after nebulization (T40) and at the end of the physiotherapist's intervention (T60). It will be reassessed 48 hours after the session (T48h) and the protocol will be repeated completely if it has not dropped at least two points according to the scales.

Conditions

• Bronchiolitis

Interventions

OTHER

Assisted autogenous drainage group (DAA)

DAA, is used when the patient is not able to perform this technique autonomously and is assisted by the physiotherapist. Its greatest utility is in infants and preschoolers. The technique consists of positioning the patient in a supine position with the head slightly elevated on the supporting plane and then placing both hands around the rib cage and applying bimanual expiratory compression on both hemithoraxes. The physiotherapist must ensure that the child takes 2 to 3 controlled breaths, close to the residual level, with the objective that the expiratory flow displaces the secretions, located distally, towards the central airways.

OTHER

Group prolonged slow expiration (ELPr)

Passive expiratory aid technique applied to the baby by means of a slow thoracic-abdominal pressure that begins at the end of a spontaneous expiration and continues until the residual volume. The physiotherapist through the provoked cough or stimulation of the trachea achieves the expectoration of the sputum.

OTHER

Control group (CG)

Nebulization with 4 ml Muconeb® 3% hypertonic serum, for 8 minutes in a Philips® vibrating mesh nebulizer. Once the nebulization is finished, you will wait 30 minutes in a closed room.

Sponsors & Collaborators

• Fisiobronquial Clínicas

  collaborator OTHER

• Guadarrama Hospital

  lead OTHER

Principal Investigators

• Juan Nicolas Mr Cuenca Zaldívar · Hospital Guadarrama, servicio de fisioterapia

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

2 Months

Max Age

12 Months

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-11-01

Primary Completion

2022-03-06

Completion

2022-04-06

Countries

• Spain

Study Locations