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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
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Paris, Frankrike, 75020
- Hospital Armand Trousseau, Pediatric Pulmonology department and ENT department
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Diagnostisk
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Experimentell: 1
Children with upper airway obstruction
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Endoscopic evaluation done under general anaesthesia.
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Aktiv komparator: 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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
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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
Tidsram: At the inclusion visit
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At the inclusion visit
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Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
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To evaluate the feasibility of the acoustic method for the evaluation of UAO in children
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: At the inclusion and 3 months visits
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At the inclusion and 3 months visits
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Samarbetspartners och utredare
Utredare
- Huvudutredare: Nicolas LEBOULANGER, MD, Assistance Publique - Hôpitaux de Paris
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- P 080606
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