Use Of The ABSS In Infants With ARIS Treated With Outpatient Respiratory Physiotherapy

• Conditions: Acute Disease Respiratory
• Interventions: Diagnostic Test: Acute Bronchiolitis Severity Scale (ABSS)

• Registration Number: NCT04036591
• Lead Sponsor: FisioRespiración

Brief Summary

Background. Acute respiratory infections in childhood have high incidence and morbimortality rates, generating significant sanitary and social costs. Due to its diversity of manifestations and clinical forms, the degree of severity varies widely.

Published acute respiratory infections assessment severity scales are mainly focused on acute bronchiolitis, but there is no validated scale to evaluate the effects of respiratory physiotherapy in acute respiratory infections in children.

Objective. To study the usefulness of the Acute Bronchiolitis Severity Scale to assess children under 24 months suffering from acute respiratory infections susceptible to receive outpatient respiratory physiotherapy treatment.

Methods. Pre-post assessment descriptive study using the Acute Bronchiolitis Severity Scale. Children under 24 months suffering from acute respiratory infection will be evaluated during the first outpatient respiratory physiotherapy treatment.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-02-26
• Status Verified: 2019-07
• Study First Submitted: 2019-07-23
• Study First Submitted QC: 2019-07-25
• Last Update Submitted: 2019-07-25
• Study First Posted: 2019-07-30
• Last Update Posted: 2019-07-30
• Primary Completion: 2021-04
• Study Completion: 2021-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

• Under 24 months
• ARIS diagnosed
• Medical indication of respiratory physiotherapy
• Evaluated during the first outpatient respiratory physiotherapy treatment

Exclusion Criteria

• Chronic desease
• ABSS ≥ 7
• Temperature≥ 38ºC
• Stridor
• Expiratory groan
• Sternal sinking
• Any sign or symptom indicative of need for urgent medical evaluation

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Children under 24 months with ARIS	Acute Bronchiolitis Severity Scale (ABSS)	-

Primary Outcome Measures

Name	Time	Method
Usefulness of Acute Bronchiolitis Severity Score (ABSS) to asses children under 24 months suffering from acute respiratory infection susceptible to receive outpatient respiratory physiotherapy treatment.	Through study completion, an average of 2 years.	Physiotherapists will use the Acute Bronchiolitis Severity Score (ABSS) to assess severity of infection pre and post treatment. After several assessments each one of them will inform about the usefulness and aplicability of the scale in outpatient respiratory physiotherapy treatment by filling in a likert scale (usefulness, aplicability, simplicity, time required...)
Immediate effectiveness of outpatient respiratory physiotherapy treatment.	Measurements will be taken during the outpatient respiratory physiotherapy treatment, 1 hour approximately. Pre treatment data will be collected before starting the treatment and post data 5 minutes after finishing the last manouver.	Change from baseline in the Acute Bronchiolitis Severity Score (ABSS) punctuation at the end of outpatient respiratory physiotherapy treatment (pre-post treatment measurement of the scale).; The ABSS is a validated scale in a Spanish population that combines the evaluation of heart and respiratory rate, wheezings, crackles, respiratory effort and inspiration/exhalation ratio. It has three levels of severity: mild (0 to 4 points), moderate (5 to 9) and severe (10 to 13).

Trial Locations

Locations (1)

FisioRespiración; 🇪🇸 Madrid, Spain