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

Use Of The "Acute Bronchiolitis Severity Scale" In Infants With Acute Respiratory Infection Susceptible To Outpatient Respiratory PhysiotherapyTreatment

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.

Study Overview

• Status: Unknown
• Conditions: Acute Disease Respiratory
• Intervention / Treatment: Diagnostic test: Acute Bronchiolitis Severity Scale (ABSS)

• Study Type: Observational
• Enrollment (Anticipated): 32

Contacts and Locations

• Study Contact: Name: Beatriz Simón Rodríguez; Phone Number: 0034629441102; Email: beatriz_simon@fisiorespiracion.es

Study Locations

• Spain
  • Madrid, Spain, 28049
    • Recruiting
    • FisioRespiración
    • Contact: Beatriz Simón Rodríguez; Phone Number: 0034629441102; Email: beatriz_simon@fisiorespiracion.es

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

All children who attend to FisioRespiración (Private respiratory physiotherapy unit in Madrid) to receive outpatient respiratory physiotherapy treatment and meet the inclusion/exclusion criteria will be selected until reaching the sample.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Children under 24 months with ARIS

Diagnostic test: Acute Bronchiolitis Severity Scale (ABSS); All infants will be assessed using the Acute Bronchiolitis Severity Scale (ABSS) before and after being treated by experienced physiotherapists using the prolonged slow expiration technique and provoqued cough. Before the application of these techniques a retrograde rhinopharyngeal unclogging will be performed in order to clean the nasopharynx.; Other Names: Chest Physiotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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...)	Through study completion, an average of 2 years.
Immediate effectiveness of outpatient respiratory physiotherapy treatment.	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).	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.

Collaborators and Investigators

• Sponsor: FisioRespiración
• Collaborators: Universidad Complutense de Madrid; Neumomadrid

Study record dates

Study Major Dates

• Study Start (Actual): February 26, 2019
• Primary Completion (Anticipated): April 1, 2021
• Study Completion (Anticipated): May 1, 2021

Study Registration Dates

• First Submitted: July 23, 2019
• First Submitted That Met QC Criteria: July 25, 2019
• First Posted (Actual): July 30, 2019

Study Record Updates

• Last Update Posted (Actual): July 30, 2019
• Last Update Submitted That Met QC Criteria: July 25, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: infant; Clinical scale; respiratory therapy
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Acute Disease; Respiratory Tract Diseases
• Other Study ID Numbers: 19/058-E_TFM

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No