Skip to content

Safety of Airway Clearance in Non-hospitalized Infants With Acute Viral Bronchiolitis

Safety of Airway Clearance Combined With Bronchodilator and Hypertonic Saline in Non-hospitalized Infants With Acute Viral Bronchiolitis

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03835858
Enrollment
265
Registered
2019-02-11
Start date
2019-03-01
Completion date
2019-05-05
Last updated
2020-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bronchiolitis

Keywords

Physical Therapy, Respiratory, Pediatric

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.

Interventions

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 the provoked cough or stimulation of the trachea achieves the expectoration of the sputum.

Sponsors

Fisiobronquial Clínicas
CollaboratorOTHER
Guadarrama Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Prospective, quasi-experimental study

Eligibility

Sex/Gender
ALL
Age
2 Months to 12 Months
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Wang clinical severity scale12 weeksThe clinical severity scale of Wang evaluates the respiratory rate, the presence of wheezing and intercostal retraction, and the patient's general condition, puncturing each dimension from 0 (the possible state) to 3 (values within normal), in addition to offer different cut points for children with more or less than 6 months.

Secondary

MeasureTime frameDescription
Oxygen saturation12 weeksMeasured by a pulse oximeter (Radical 7 Touchscreen by Massimo®, Masimo Corporation, Irvine, CA).

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026