CClinicalTrials.gg
Status unknownNCT04036591Updated Jul 30, 2019

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

An observational study in Acute Disease Respiratory, sponsored by FisioRespiración. Status unknown at 1 site in Spain. Open to participants aged 1 Day to 24 Months. Per ClinicalTrials.gov, last updated 2019-07-30.

Sponsored by FisioRespiración · Observational

The sponsor has not verified this record recently (last verified Jul 2019), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
32
Ages
1 Day to 24 Months
Sex
All
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Study 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.

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Conditions studied

  • Acute Disease Respiratory

Keywords

  • Clinical scale
  • infant
  • respiratory therapy
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In context

Respiratory Tract Diseases

617 studies on the registry are indexed under Respiratory Tract Diseases; 111 are open to participants now.

This study's planned enrollment of 32 is below the median of 294 across 216 observational studies indexed under Respiratory Tract Diseases.

Browse Respiratory Tract Diseases studies →

Lead sponsor

This is the only study on the registry with FisioRespiración as lead sponsor.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
1 Day to 24 Months
Sexes eligible
All
Accepts healthy volunteers
No
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.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Observational model
Other
Time perspective
Cross-sectional
Enrollment
32 participants (estimated)
Target follow-up
1 Day
Patient registry
Yes

Groups and cohorts

  • Children under 24 months with ARIS

    Diagnostic Test: Acute Bronchiolitis Severity Scale (ABSS)

Interventions

  • Diagnostic testAcute 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.

    Also known as: Chest Physiotherapy

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What researchers measure

Primary outcomes

  1. 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...)

    Time frame: Through study completion, an average of 2 years.

  2. 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).

    Time frame: 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.

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Study locations

1 of 1 sites recruiting
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 30, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04036591
Lead sponsor
FisioRespiración
Collaborators
Neumomadrid, Universidad Complutense de Madrid
Responsible party
Beatriz Simón Rodríguez (FisioRespiración CEO and physiotherapist, FisioRespiración) — Principal investigator
First posted
Jul 30, 2019
Start date
Feb 26, 2019
Primary completion
Apr 2021 (estimated)
Completion
May 2021 (estimated)
Last update
Jul 30, 2019

Study contacts

Beatriz Simón Rodríguez
Contact
beatriz_simon@fisiorespiracion.es
0034629441102

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.

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