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

NCT ID: NCT03835858

Last Updated: 2020-05-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 265 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-01
• Study Completion Date: 2019-05-05

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.

Conditions

Bronchiolitis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

Respiratory physiotherapy

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

• 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.

• Minimum Eligible Age: 2 Months
• Maximum Eligible Age: 12 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fisiobronquial Clínicas

OTHER

Sponsor Role: collaborator

Guadarrama Hospital

OTHER

Sponsor Role: lead

Responsible Party

J. Nicolas Cuenca Zaldivar

Rehabilitation Service Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

J. Nicolas Cuenca Zaldivar

Role: PRINCIPAL_INVESTIGATOR

Guadarrama Hospital

Locations

J.Nicolas Cuenca Zaldivar

Guadarrama, Madrid, Spain

Countries

Spain

Other Identifiers

6.0

Identifier Type: -

Identifier Source: org_study_id