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.
調査の概要
状態
条件
詳細な説明
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.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Paris、フランス、75020
- Hospital Armand Trousseau, Pediatric Pulmonology department and ENT department
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：診断
- 割り当て：非ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：1
Children with upper airway obstruction
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Endoscopic evaluation done under general anaesthesia.
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アクティブコンパレータ：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
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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
時間枠：At the inclusion visit
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At the inclusion visit
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二次結果の測定
結果測定 |
時間枠 |
|---|---|
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To evaluate the feasibility of the acoustic method for the evaluation of UAO in children
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：At the inclusion and 3 months visits
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At the inclusion and 3 months visits
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協力者と研究者
捜査官
- 主任研究者：Nicolas LEBOULANGER, MD、Assistance Publique - Hôpitaux de Paris
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。