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

Primary Purpose

Bronchiolitis

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Respiratory physiotherapy
Sponsored by
Guadarrama Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bronchiolitis focused on measuring Physical Therapy, Respiratory, Pediatric

Eligibility Criteria

2 Months - 12 Months (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • J.Nicolas Cuenca Zaldivar

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Respiratory physiotherapy

Arm Description

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.

Outcomes

Primary Outcome Measures

Wang clinical severity scale
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

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

Full Information

First Posted
February 7, 2019
Last Updated
May 11, 2020
Sponsor
Guadarrama Hospital
Collaborators
Fisiobronquial Clínicas
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1. Study Identification

Unique Protocol Identification Number
NCT03835858
Brief Title
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

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
March 1, 2019 (Actual)
Primary Completion Date
May 5, 2019 (Actual)
Study Completion Date
May 5, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Guadarrama Hospital
Collaborators
Fisiobronquial Clínicas

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchiolitis
Keywords
Physical Therapy, Respiratory, Pediatric

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Prospective, quasi-experimental study
Masking
None (Open Label)
Allocation
N/A
Enrollment
265 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Respiratory physiotherapy
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Respiratory physiotherapy
Intervention Description
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 Outcome Measure Information:
Title
Wang clinical severity scale
Description
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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Oxygen saturation
Description
Measured by a pulse oximeter (Radical 7 Touchscreen by Massimo®, Masimo Corporation, Irvine, CA).
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Months
Maximum Age & Unit of Time
12 Months
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
J. Nicolas Cuenca Zaldivar
Organizational Affiliation
Guadarrama Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
J.Nicolas Cuenca Zaldivar
City
Guadarrama
State/Province
Madrid
ZIP/Postal Code
28440
Country
Spain

12. IPD Sharing Statement

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

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