Treatment of Pediatric Bronchiolitis

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

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.

Study Overview

• Status: Completed
• Conditions: Bronchiolitis
• Intervention / Treatment: Other: Manual maneuvers physiotherapy group; Other: High frequency compression of the chest wall group

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 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.

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid
    • Guadarrama, Madrid, Spain, 28440
      • J.Nicolas Cuenca Zaldivar

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 months to 1 year (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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: 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.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oxygen saturation	Measured by a pulse oximeter (Radical 7 Touchscreen by Massimo®, Masimo Corporation, Irvine, CA).	12 weeks
Heart rate	Measured by a pulse oximeter (Radical 7 Touchscreen by Massimo®, Masimo Corporation, Irvine, CA).	12 weeks
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

Collaborators and Investigators

• Sponsor: Guadarrama Hospital
• Collaborators: Fisiobronquial Clínicas

Publications and helpful links

General Publications

• Gonzalez-Bellido V, Velaz-Baza V, Blanco-Moncada E, Del Carmen Jimeno Esteo M, Cuenca-Zaldivar JN, Colombo-Marro A, Donadio MVF, Torres-Castro R. Immediate Effects and Safety of High-Frequency Chest Wall Compression Compared to Airway Clearance Techniques in Non-Hospitalized Infants With Acute Viral Bronchiolitis. Respir Care. 2021 Mar;66(3):425-433. doi: 10.4187/respcare.08177. Epub 2020 Nov 3.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2019
• Primary Completion (Actual): May 10, 2019
• Study Completion (Actual): May 10, 2019

Study Registration Dates

• First Submitted: February 7, 2019
• First Submitted That Met QC Criteria: February 8, 2019
• First Posted (Actual): February 11, 2019

Study Record Updates

• Last Update Posted (Actual): June 11, 2020
• Last Update Submitted That Met QC Criteria: June 9, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: Pediatric; Physical Therapy; Respiratory
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Bronchitis; Bronchiolitis
• Other Study ID Numbers: 5.0

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No