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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Paris, Francia, 75020
- Hospital Armand Trousseau, Pediatric Pulmonology department and ENT department
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Diagnostico
- Assegnazione: Non randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: 1
Children with upper airway obstruction
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Endoscopic evaluation done under general anaesthesia.
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Comparatore attivo: 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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
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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
Lasso di tempo: At the inclusion visit
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At the inclusion visit
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Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
|---|---|
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To evaluate the feasibility of the acoustic method for the evaluation of UAO in children
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: At the inclusion and 3 months visits
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At the inclusion and 3 months visits
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Collaboratori e investigatori
Investigatori
- Investigatore principale: Nicolas LEBOULANGER, MD, Assistance Publique - Hopitaux de Paris
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- P 080606
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