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High Frequency Compression of the Thoracic Wall in Children With Bronchiolitis

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: NCT03835936
Recruitment Status : Completed
First Posted : February 11, 2019
Last Update Posted : May 13, 2019
Sponsor:
Collaborator:
Fisiobronquial Clínicas
Information provided by (Responsible Party):
J. Nicolas Cuenca Zaldivar, Guadarrama Hospital

Brief Summary:
Bronchiolitis (BQ) is the acute viral infection of the tract respiratory syndrome in infants that affects the bronchioles of babies under 24 months of age. Respiratory physiotherapy (RF) appears as a treatment measure complementary in the clinical guidelines and consensus on the management of the BQ.

Condition or disease Intervention/treatment Phase
Bronchiolitis Other: High frequency compression of the chest wall group Other: Manual maneuvers physiotherapy group 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.

The assignment will be made at the time of query according to a table of random numbers previously established and that it will only be known by physiotherapists.

Before starting the treatment protocol, a blind evaluator who does not know the treatment to which the patient is assigned, classifies the child according to the initial score of clinical severity proposed by Wang, in addition to the measurement of SO2 and frequency heart rate through a pulse oximeter. The measurement of the amount of sputum collected in a meter measuring cup, once the respiratory physiotherapy session is finished, it will be done in a calibrated weight in both groups.

The protocol in the manual maneuvers group consists of 20 minutes of FR based on prolonged slow expiration and coughing provoked. Is apassive technique of expiratory help applied to the baby through a slow thoracic-abdominal pressure that begins at the end of spontaneous expiration and continues to the residual volume. The physiotherapist through the cough provoked or stimulation of the trachea gets expectoration of sputum, to be able to assess its weight.

The protocol in the high frequency compression chest wall group consists of the same protocol as the respiratory physiotherapy Group plus high frequency compression chest wall applied with Smart Vest® device, with a fixed frequency of 13 Hz and a time 15 min. The selected mode will be the normal (fixed parameters) and the pressure of 4 units (12 cm H2O). The patient remains seated on his parents, and with a cotton garment between the vest and the skin of the patient to prevent skin lesions.

Attention must be paid during maneuvers to maintain a position of infant in supine decubitus in 30 degrees of slope, to avoid episodes of gastroesophageal reflux and decrease the risk of vomiting.

Criteria for cessation of physiotherapeutic intervention, alterations will be considered 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 manifestations clinics, it is established that if the parent or legal guardian so requires, the the application of the protocol.

After 10 minutes of finishing both groups, the doctor again makes a measurement of mucus volume, SO2, heart and respiratory rate, and classify again according to the criteria of Wang's clinical severity scale.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Single-blind controlled clinical trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Mucociliary Clearance Techniques vs. High Frequency Compression of the Thoracic Wall in Children Not Hospitalized With Mild and Moderate Bronchiolitis: A Randomized Clinical Trial
Actual Study Start Date : March 1, 2019
Actual Primary Completion Date : May 10, 2019
Actual Study Completion Date : May 10, 2019

Arm Intervention/treatment
Active Comparator: Manual maneuvers physiotherapy
The protocol of physiotherapy treatment techniques consists of 20 minutes of FR based on prolonged slow expiration and cough provoked.
Other: Manual maneuvers physiotherapy group
20 minutes of manual maneuvers physiotherapy based on prolonged slow expiration: passive technique of expiratory help applied to the baby through a slow thoracic-abdominal pressure that begins at the end of spontaneous expiration and continues to the residual volume. The physiotherapist through the cough provoked or stimulation of the trachea gets expectoration of sputum, to be able to assess its weight.

Experimental: High frequency compression chest wall
The protocol consists in the application of the Smart Vest® device for high frequency compression of the chest wall, with a fixed frequency of 13 Hz and a time of 15 minutes. Then during 20 minutes will apply the same protocol as in the manual maneuvers group.
Other: High frequency compression of the chest wall group
The protocol in the high frequency compression of the chest wall group device consists of the Smart Vest® application, with a fixed frequency of 13 Hz and a time of 15 minutes. The selected mode will be the normal (fixed parameters) and the pressure of 4 units (12 cm H2O). The patient remains seated on his parents, and with a cotton garment between the vest and the skin of the patient to prevent skin lesions.

Other: Manual maneuvers physiotherapy group
20 minutes of manual maneuvers physiotherapy based on prolonged slow expiration: passive technique of expiratory help applied to the baby through a slow thoracic-abdominal pressure that begins at the end of spontaneous expiration and continues to the residual volume. The physiotherapist through the cough provoked or stimulation of the trachea gets expectoration of sputum, to be able to assess its weight.




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).

  2. Heart rate [ Time Frame: 12 weeks ]
    Measured by a pulse oximeter (Radical 7 Touchscreen by Massimo®, Masimo Corporation, Irvine, CA).

  3. Amount of sputum [ Time Frame: 12 weeks ]
    The measurement of the amount of sputum collected in a metric measuring cup, once the session is finished, will be done in a calibrated weight



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 a medical diagnosis of the first episode of BQ.
  • Have the informed consent signed by the child's legal guardians.

Exclusion Criteria:

The criteria of exclusion are:

  • BQ in acute phase with score> 9 according to Wang clinical scale.
  • Associated cardiac, neurological or traumatic pathology.
  • Previous hospitalization 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): NCT03835936


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: NCT03835936    
Other Study ID Numbers: 5.0
First Posted: February 11, 2019    Key Record Dates
Last Update Posted: May 13, 2019
Last Verified: February 2019

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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