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临床试验/NCT02897960
NCT02897960已完成不适用

Wheezing Diagnosis Using a Smartphone in Infants Referred for Bronchiolitis

Assistance Publique - Hôpitaux de Paris1 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2016年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
600
试验地点
1
主要终点
positive and negative predictive values of the algorithm for wheezing diagnosis

研究概览

简要总结

Abnormal respiratory sounds (wheezing and/or crackles) are diagnosis criteria of acute bronchiolitis. One third of these infants will develop recurrent episodes, leading to the diagnosis of infant asthma. Nowadays, no available treatment shortens the course of bronchiolitis or hastens the resolution of symptoms, thus, therapy is supportive. Our hypothesis is that the diagnosis of wheezing during bronchiolitis (~60% of infants) will help to select infants who will benefit from anti-asthma therapy. In this setting the diagnosis of wheezing is crucial, and an objective tool for recognition of wheezing is of clinical value. The investigators developed a wheezing recognition algorithm from recorded respiratory sounds with a Smartphone placed near the mouth (Bokov P, Comput Biol Med, 2016). The objectives of the present cross sectional, observational study are 1/ to further validate our approach in a larger sample of infants (1 to 24 months) admitted to hospital for a respiratory complaint during the period of viral bronchiolitis, and 2/ to use gold standard diagnosis of wheezing by respiratory sound recording (Littmann) and subsequent analysis by two experienced pediatricians.

详细描述

Infants (1 to 24 months old) are recruited in two emergency departments (Robert Debré; Antoine Béclère hospitals of Assistance publique - Hôpitaux de Paris) based on a respiratory complaint. Six characteristics are recorded (age, sex, SpO2, presence or absence of wheezing, other respiratory sound, initial diagnosis). Two recordings of respiratory sounds are obtained almost simultaneously: one with a Smartphone at the mouth (5 cm) and one with an electronic stetoscope (Littmann). Two expert pediatricians listen the recordings giving thee groups: with wheezing (agreement), without wheezing (agreement) and non agreement diagnosis. The recordings made with the Smartphone are subjected to the wheezing recognition algorithm as previously described. The sensitivity, specificity, PPV, NPP are then evaluated. The algorithm will further be improved if necessary using the true negative and true positive recordings (those with expert agreement).

研究设计

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

入排标准

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

入选标准

  • infant 1 to 24 months old
  • respiratory complaint in the emergency room

排除标准

  • 未提供

结局指标

主要结局

positive and negative predictive values of the algorithm for wheezing diagnosis

时间窗: 8 months

次要结局

  • sensibility and specificity of the algorithm in subgroups(8 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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