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临床试验/NCT04036591
NCT04036591Unknown不适用

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

FisioRespiración1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2019年2月26日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
32
试验地点
1
主要终点
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.

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

年龄范围
1 Day 至 24 Months(Child)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

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.

时间窗: 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.

时间窗: 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).

次要结局

未报告次要终点

研究者

发起方
FisioRespiración
申办方类型
Other
责任方
Principal Investigator
主要研究者

Beatriz Simón Rodríguez

FisioRespiración CEO and physiotherapist

FisioRespiración

研究点 (1)

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