Acoustic Reflection Method and Work of Breathing (MAVAS)
Acoustic Reflection Method and Work of Breathing : Two New Methods to Measure Children's Upper Airway Obstruction
Upper airway obstruction (UAO) is very common in children. Presently, the importance of the UAO is evaluated by the physician during an endoscopic evaluation under general anaesthesia.
The aim of the study is to evaluate two new techniques to quantify the importance of the UAO in children; the acoustic reflection method and the measurement of the work of breathing.
80 children will be included in this monocentric, prospective, open labelled study.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
The following evaluations will be performed the day prior to the endoscopic evaluation :1) calculation of a clinical score based on the diurnal and nocturnal respiratory and nutritional tolerance of the UAO, 2) evaluation of the importance and the localisation of the UAO assessed by the acoustic reflection method, 3) measurement of the work of breathing, 4) recording of nocturnal gas exchange during at least 6 hours by s single monitor (Sentec™) which measures pulse oximetry (SaO2) and transcutaneous carbon dioxide (PtcCO2), and evaluation of sleep quality by actigraphy (recording of patient's movements by an Actiwatch™).
All the patients will be re-assessed after 3 months. If no treatment is required, a second clinical evaluation with an acoustic reflection examination will be performed. If a surgical treatment or a noninvasive positive pressure ventilation will be necessary, a second complete evaluation will be performed with an endoscopic examination, the calculation of the clinical score, an acoustic reflection examination, the measurement of the work of breathing, and the recording of the nocturnal gas exchange and sleep quality. This second endoscopic examination will be performed only for medical purpose and not for research only.
The study will last 24 months, comprising 21 months for the inclusion of the patients and 3 months for the analysis of the data.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Paris, France, 75020
- Hospital Armand Trousseau, Pediatric Pulmonology department and ENT department
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- children aged 0 to 15 years old,
- in a stable state,
- presenting an UAO which requires an endoscopic evaluation under general anaesthesia
- signed informed consent
- affiliation to french health benefits
Exclusion Criteria:
- UAO due solely to a hypertrophy of the adenoids and/or the tonsils,
- patients with a tracheostomy or a non operated cleft palate
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Diagnostique
- Répartition: Non randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: 1
Children with upper airway obstruction
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Endoscopic evaluation done under general anaesthesia.
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Comparateur actif: 2
Children without upper airway obstruction
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Acoustic reflection gives the longitudinal cross-sectional area profile along airway.Based on planar acoustic wave propagating in a rigid duct connected to airway.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
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To compare the importance and the localisation of the UAO assessed by the acoustic reflection method and by the endoscopic evaluation under general anaesthesia
Délai: At the inclusion visit
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At the inclusion visit
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Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
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To evaluate the feasibility of the acoustic method for the evaluation of UAO in children
Délai: At the inclusion visit
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At the inclusion visit
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To compare the importance and the localisation of the UAO assessed by the acoustic reflection method with the respiratory (during sleep and wakefulness) and nutritional consequences of the UAO
Délai: At the inclusion visit
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At the inclusion visit
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To compare the importance of the UAO assessed by the acoustic reflection method with the measurements of the work of breathing
Délai: At the inclusion visit
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At the inclusion visit
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To compare the importance and the localisation of the UAO assessed by the acoustic reflection method with the results of a high resolution computed tomography scan of the upper airways if done for the medical reasons
Délai: At the inclusion visit
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At the inclusion visit
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To correlate the importance and the localisation of the UAO assessed by the acoustic reflection method with the outcome of surgery if required
Délai: At the inclusion and 3 months visits
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At the inclusion and 3 months visits
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Nicolas LEBOULANGER, MD, Assistance Publique - Hôpitaux de Paris
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- P 080606
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