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OpenTrials
Completed

NCT Number: NCT02897960

Wheezing Diagnosis Using a Smartphone

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.

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Key information

Age range

1 month–24 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Robert Debré; service de Physiologie

Paris, 75019, France

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

Treatment and study plan

Primary outcomes

  1. positive and negative predictive values of the algorithm for wheezing diagnosis

    Time frame: 8 months

Secondary outcomes

  1. sensibility and specificity of the algorithm in subgroups

    Time frame: 8 months

    The sensibility and specificity of the algorithm will be assessed for recordings with other respiratory sounds (crackles for instance) The agreement (kappa value) between the emergency room sound diagnosis and both the expert and algorithm diagnosis (diagnostic ability of the physician in the emergency room)

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

Wheezing Diagnosis Using a Smartphone in Infants Referred for Bronchiolitis

Acronym: WheezSmart

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Sep 13, 2016
Registry last updated
Feb 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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