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
1 other identifier
interventional
70
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2019
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 7, 2019
CompletedFirst Posted
Study publicly available on registry
February 11, 2019
CompletedStudy Start
First participant enrolled
March 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 10, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
May 10, 2019
CompletedJune 11, 2020
June 1, 2020
2 months
February 7, 2019
June 9, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Oxygen saturation
12 weeks
Heart rate
12 weeks
Amount of sputum
12 weeks
Study Arms (2)
Manual maneuvers physiotherapy
ACTIVE COMPARATORThe protocol of physiotherapy treatment techniques consists of 20 minutes of FR based on prolonged slow expiration and cough provoked.
High frequency compression chest wall
EXPERIMENTALThe 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Guadarrama Hospitallead
- Fisiobronquial Clínicascollaborator
Study Sites (1)
J.Nicolas Cuenca Zaldivar
Guadarrama, Madrid, 28440, Spain
Related Publications (2)
Roque-Figuls M, Gine-Garriga M, Granados Rugeles C, Perrotta C, Vilaro J. Chest physiotherapy for acute bronchiolitis in paediatric patients between 0 and 24 months old. Cochrane Database Syst Rev. 2023 Apr 3;4(4):CD004873. doi: 10.1002/14651858.CD004873.pub6.
PMID: 37010196DERIVEDGonzalez-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.
PMID: 33144386DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
J. Nicolas Cuenca Zaldivar
Guadarrama Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Rehabilitation Service Principal Investigator
Study Record Dates
First Submitted
February 7, 2019
First Posted
February 11, 2019
Study Start
March 1, 2019
Primary Completion
May 10, 2019
Study Completion
May 10, 2019
Last Updated
June 11, 2020
Record last verified: 2020-06