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

Sponsor
Guadarrama Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03835858
Collaborator
Fisiobronquial Clínicas (Other)
265
1
1
2.1
124.1

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Other: Respiratory physiotherapy
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
265 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Prospective, quasi-experimental studyProspective, quasi-experimental study
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Safety of Airway Clearance Combined With Bronchodilator and Hypertonic Saline in Non-hospitalized Infants With Acute Viral Bronchiolitis
Actual Study Start Date :
Mar 1, 2019
Actual Primary Completion Date :
May 5, 2019
Actual Study Completion Date :
May 5, 2019

Arms and Interventions

Arm Intervention/Treatment
Other: Respiratory physiotherapy

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.

Other: Respiratory physiotherapy
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.

Outcome Measures

Primary Outcome Measures

  1. Wang clinical severity scale [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 Outcome Measures

  1. Oxygen saturation [12 weeks]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
2 Months to 12 Months
Sexes Eligible for Study:
All
Accepts 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 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 J.Nicolas Cuenca Zaldivar Guadarrama Madrid Spain 28440

Sponsors and Collaborators

  • Guadarrama Hospital
  • Fisiobronquial Clínicas

Investigators

  • Principal Investigator: J. Nicolas Cuenca Zaldivar, Guadarrama Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
J. Nicolas Cuenca Zaldivar, Rehabilitation Service Principal Investigator, Guadarrama Hospital
ClinicalTrials.gov Identifier:
NCT03835858
Other Study ID Numbers:
  • 6.0
First Posted:
Feb 11, 2019
Last Update Posted:
May 13, 2020
Last Verified:
May 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by J. Nicolas Cuenca Zaldivar, Rehabilitation Service Principal Investigator, Guadarrama Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 13, 2020