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OpenTrials
Completed

NCT Number: NCT03835858

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

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

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Key information

Age range

2 month–12 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

J.Nicolas Cuenca Zaldivar

Guadarrama, Madrid, 28440, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Respiratory physiotherapy

Other

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.

Primary outcomes

  1. Wang clinical severity scale

    Time frame: 12 weeks

    The 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 outcomes

  1. Oxygen saturation

    Time frame: 12 weeks

    Measured by a pulse oximeter (Radical 7 Touchscreen by Massimo®, Masimo Corporation, Irvine, CA).

Sponsors and collaborators

Lead sponsor

Guadarrama Hospital

Other

Collaborators

  • Fisiobronquial Clínicas

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Feb 11, 2019
Registry last updated
May 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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