Acute Disease Respiratory Clinical Trial
Official title:
Use Of The "Acute Bronchiolitis Severity Scale" In Infants With Acute Respiratory Infection Susceptible To Outpatient Respiratory PhysiotherapyTreatment
| NCT number | NCT04036591 |
| Other study ID # | 19/058-E_TFM |
| Secondary ID | |
| Status | Recruiting |
| Phase | |
| First received | |
| Last updated | |
| Start date | February 26, 2019 |
| Est. completion date | May 2021 |
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.
| Status | Recruiting |
| Enrollment | 32 |
| Est. completion date | May 2021 |
| Est. primary completion date | April 2021 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A to 24 Months |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Spain | FisioRespiración | Madrid |
| Lead Sponsor | Collaborator |
|---|---|
| FisioRespiración | Neumomadrid, Universidad Complutense de Madrid |
Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | |
| Primary | 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. |