Bronchiolitis Clinical Trial
Official title:
Immediate Effects and Safety of High-frequency Chest Wall Oscillation Compared to Airway Clearance Techniques in Non-hospitalized Infants With Acute Viral Bronchiolitis
Bronchiolitis (BQ) is the acute viral infection of the tract respiratory syndrome in infants that affects the bronchioles of babies under 24 months of age. Respiratory physiotherapy (RF) appears as a treatment measure complementary in the clinical guidelines and consensus on the management of the BQ.
Once each patient legal guardians has signed the informed consent document and it has been
verified that the inclusion criteria are met, it will be assigned the same identification
number (ID) that is related to its Clinical History (CH) by simple coding; custody of the
file with the relationship of each ID with its CH will be the responsibility of the principal
investigator.
The assignment will be made at the time of query according to a table of random numbers
previously established and that it will only be known by physiotherapists.
Before starting the treatment protocol, a blind evaluator who does not know the treatment to
which the patient is assigned, classifies the child according to the initial score of
clinical severity proposed by Wang, in addition to the measurement of SO2 and frequency heart
rate through a pulse oximeter. The measurement of the amount of sputum collected in a meter
measuring cup, once the respiratory physiotherapy session is finished, it will be done in a
calibrated weight in both groups.
The protocol in the manual maneuvers group consists of 20 minutes of FR based on prolonged
slow expiration and coughing provoked. Is apassive technique of expiratory help applied to
the baby through a slow thoracic-abdominal pressure that begins at the end of spontaneous
expiration and continues to the residual volume. The physiotherapist through the cough
provoked or stimulation of the trachea gets expectoration of sputum, to be able to assess its
weight.
The protocol in the high frequency compression chest wall group consists of the same protocol
as the respiratory physiotherapy Group plus high frequency compression chest wall applied
with Smart Vest® device, with a fixed frequency of 13 Hz and a time 15 min. The selected mode
will be the normal (fixed parameters) and the pressure of 4 units (12 cm H2O). The patient
remains seated on his parents, and with a cotton garment between the vest and the skin of the
patient to prevent skin lesions.
Attention must be paid during maneuvers to maintain a position of infant in supine decubitus
in 30 degrees of slope, to avoid episodes of gastroesophageal reflux and decrease the risk of
vomiting.
Criteria for cessation of physiotherapeutic intervention, alterations will be considered
abrupt of the respiratory rhythm (brady or tachypnea), stare, ocular revulsion, hiccups or
hypertonia and changes in skin color (pallor or cyanosis). In addition to these
manifestations clinics, it is established that if the parent or legal guardian so requires,
the the application of the protocol.
After 10 and 20 minutes of finishing both groups, the doctor again makes a measurement of
mucus volume, SO2, heart and respiratory rate, and classify again according to the criteria
of Wang's clinical severity scale.
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