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Wheezing Diagnosis Using a Smartphone (WheezSmart)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified August 2016 by Assistance Publique - Hôpitaux de Paris
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT02897960
First received: September 1, 2016
Last updated: September 7, 2016
Last verified: August 2016
  Purpose
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.

Condition
Bronchiolitis

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Wheezing Diagnosis Using a Smartphone in Infants Referred for Bronchiolitis

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • positive and negative predictive values of the algorithm for wheezing diagnosis [ Time Frame: 8 months ]

Secondary Outcome Measures:
  • 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)


Estimated Enrollment: 600
Study Start Date: October 2016
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: April 2017 (Final data collection date for primary outcome measure)
Detailed Description:
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).
  Eligibility

Ages Eligible for Study:   1 Month to 24 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Infant selected in the emergency department: respiratory complaint
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02897960

Contacts
Contact: Plamen Bokov, MD, PhD 33 1 40 01 41 90 plamen.bokov@aphp.fr
Contact: Christophe Delclaux, MD, PhD 33 1 40 01 41 90 christophe.delclaux@aphp.fr

Locations
France
Hôpital Robert Debré; service de Physiologie Not yet recruiting
Paris, France, 75019
Contact: Plamen Bokov, MD, PhD    33 1 40 01 41 90    plamen.bokov@aphp.fr   
Contact: Christophe Delclaux    33 1 40 01 41 90    christophe.delclaux@aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
  More Information

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02897960     History of Changes
Other Study ID Numbers: ID RCB : 2015-A01499-40
Study First Received: September 1, 2016
Last Updated: September 7, 2016
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Assistance Publique - Hôpitaux de Paris:
wheezing
bronchiolitis
respiratory sound algorithm

Additional relevant MeSH terms:
Bronchiolitis
Respiratory Sounds
Bronchitis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections
Signs and Symptoms, Respiratory
Signs and Symptoms

ClinicalTrials.gov processed this record on April 27, 2017