Treatment of Pediatric Bronchiolitis

Bronchiolitis Clinical Trial

Official title:

Immediate Effects and Safety of High-frequency Chest Wall Oscillation Compared to Airway Clearance Techniques in Non-hospitalized Infants With Acute Viral Bronchiolitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03835936
• Other study ID #: 5.0
• Status: Completed
• Phase: N/A
• Start date: March 1, 2019
• Est. completion date: May 10, 2019

Study information

• Verified date: June 2020
• Source: Guadarrama Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 and 20 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: May 10, 2019
• Est. primary completion date: May 10, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Months to 12 Months

Eligibility

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.

Related Conditions & MeSH terms

• Bronchiolitis

Intervention

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.
• 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.

Locations

Country	Name	City	State
Spain	J.Nicolas Cuenca Zaldivar	Guadarrama	Madrid

Sponsors (2)

Lead Sponsor	Collaborator
Guadarrama Hospital	Fisiobronquial Clínicas

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 weeks
Secondary	Oxygen saturation	Measured by a pulse oximeter (Radical 7 Touchscreen by Massimo®, Masimo Corporation, Irvine, CA).	12 weeks
Secondary	Heart rate	Measured by a pulse oximeter (Radical 7 Touchscreen by Massimo®, Masimo Corporation, Irvine, CA).	12 weeks
Secondary	Amount of sputum	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	12 weeks