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Short-term Effect of Slow Expiratory Techniques for Mucociliary in Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03835858
Recruitment Status : Completed
First Posted : February 11, 2019
Last Update Posted : March 13, 2020
Sponsor:
Collaborator:
Fisiobronquial Clínicas
Information provided by (Responsible Party):
J. Nicolas Cuenca Zaldivar, Guadarrama Hospital

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
Bronchiolitis Other: Respiratory physiotherapy Not Applicable

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. At 48 hours the same medical evaluator performs the same assessment.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 265 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Prospective, quasi-experimental study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Short-term Effect of Slow Expiratory Techniques for Mucociliary Clearance for Clinical Improvement in Children Not Hospitalized With Mild and Moderate Bronchiolitis: Multicentre Study
Actual Study Start Date : March 1, 2019
Actual Primary Completion Date : May 5, 2019
Actual Study Completion Date : May 5, 2019

Arm Intervention/treatment
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.




Primary Outcome Measures :
  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 Outcome Measures :
  1. Oxygen saturation [ Time Frame: 12 weeks ]
    Measured by a pulse oximeter (Radical 7 Touchscreen by Massimo®, Masimo Corporation, Irvine, CA).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   2 Months to 12 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03835858


Locations
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Spain
J.Nicolas Cuenca Zaldivar
Guadarrama, Madrid, Spain, 28440
Sponsors and Collaborators
Guadarrama Hospital
Fisiobronquial Clínicas
Investigators
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Principal Investigator: J. Nicolas Cuenca Zaldivar Guadarrama Hospital

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Responsible Party: J. Nicolas Cuenca Zaldivar, Rehabilitation Service Principal Investigator, Guadarrama Hospital
ClinicalTrials.gov Identifier: NCT03835858    
Other Study ID Numbers: 6.0
First Posted: February 11, 2019    Key Record Dates
Last Update Posted: March 13, 2020
Last Verified: March 2020

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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, Guadarrama Hospital:
Physical Therapy
Respiratory
Pediatric
Additional relevant MeSH terms:
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Bronchiolitis
Bronchitis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections