Clinical trial NCT03835858: Safety of Airway Clearance in Non-hospitalized Infants With Acute Viral Bronchiolitis
Official title: Safety of Airway Clearance Combined With Bronchodilator and Hypertonic Saline in Non-hospitalized Infants With Acute Viral Bronchiolitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bronchiolitis
Keywords: Physical Therapy
Respiratory
Pediatric
Lead sponsor: Guadarrama Hospital
Sponsor class: OTHER
Collaborators: name: Fisiobronquial Clínicas
First posted: 2019-02-11
Enrollment: 265
Sex: ALL
Minimum age (years): 2
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective, quasi-experimental study
Primary purpose: TREATMENT

Brief summary: Bronchiolitis is a disease that can occur in a mild form and moderate, and often does not require hospitalization. The technique of prolonged slow expiration followed by cough caused in children not hospitalized with mild and moderate bronchiolitis can improve clinical severity

Detailed description: 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.

Before starting the treatment protocol, a blind evaluator treats the was assigned the patient classifies the child according to the initial score of clinical severity proposed by Wang, in addition to the measurement of SO2 and heart rate measured through a pulse oximeter.

The protocol consists of 20 minutes of FR based on nasal washes in sitting, prolonged slow expiration: passive technique of expiratory help applied to the baby through a slow thoracic-abdominal pressure that begins at the end of a spontaneous expiration and continuing to the residual volume. The physiotherapist through the provoked cough or stimulation of the trachea achieves the expectoration of the sputum.

Care must be taken during the maneuvers of maintaining a position of the infant in supine decubitus in 30 degrees of slope, to avoid episodes of gastroesophageal reflux and decrease the risk of vomiting.

They are considered as criteria of cessation of the physiotherapeutic intervention, alterations 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 clinical manifestations, it establishes that if the father or legal guardian demands it, the application of the protocol would be terminated.

In order to evaluate the immediate effect of the protocol, which is established as the effect evaluated 10 minutes immediately after the intervention was applied, the doctor again performs a measurement of SO2, heart rate and respiratory rate, and classify again according to the criteria of Wang's clinical severity scale and anotate any adverse event. At 20 minutes the same medical evaluator performs the same assessment.

Eligibility criteria: Inclusion Criteria:

Patients must meet the following inclusion criteria:

* Have an age between 2 months and 12 months.
* Have medical diagnosis of first episode of BQ of maximum 48 hours of evolution.
* Not previously received respiratory physiotherapy since its diagnosis.
* Have the informed consent signed by the child's legal guardians.

Exclusion Criteria:

The exclusion criteria are:

* Acute BQ with score\> 9 according to the Wang clinical scale.
* Pathology associated cardiac, neurological or traumatic.
* Previous hospitalizations for wheezing.
* Medical diagnosis of recurrent sibilant.

Primary outcomes:
measure: Wang clinical severity scale
timeFrame: 12 weeks
Secondary outcomes:
measure: Oxygen saturation
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Guadarrama
country: Spain
facility: J.Nicolas Cuenca Zaldivar
state: Madrid
Study officials:
affiliation: Guadarrama Hospital
name: J. Nicolas Cuenca Zaldivar
role: PRINCIPAL_INVESTIGATOR
References: