Upper Airways in Pregnancy: Evaluation by the Acoustic Reflection Method (MAVAG)
It is well known that airway management can be difficult during pregnancy. Increased risks for difficult intubation in pregnant women have been often reported. Thus, pregnancy is regarded as a period of high anesthesiologic risk.
Generalized weight gain is a well known factor influencing the upper airway in pregnant women. However, the modifications of the airway itself are less well documented.
The acoustic reflection method is based on the analysis of the reflection of a single transient planar wave allowing the analysis of the longitudinal cross-sectional area profile of the examined cavity. It is a noninvasive and harmless method.
The aim of the study is to evaluate by acoustic reflection method the physiological modifications of the upper airways during pregnancy.
Women enrolled in the study will undergo an acoustic recording during the first, second, and third trimester of pregnancy, as well as two days and one month after delivery. Forty pregnant women will be included in this monocentric, prospective, open labelled study.
Moreover, a single acoustic recording will be performed in 10 other pregnant women undergoing an MRI for obstetrical purpose. The estimated caliber of the upper airways by MRI and acoustic method will be compared.
調査の概要
研究の種類
入学 (実際)
連絡先と場所
研究場所
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Paris、フランス、75012
- Hôpital d'Enfants Armand Trousseau
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Paris、フランス、75012
- Armand Trousseau University Hospital
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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
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- Pregnant women who attend the routine ultrasound control in our institution before 14 weeks of pregnancy will be invited to participate in the study.
Women are eligible for the study if they are:
- healthy (no previous disease, hypertension, nor obesity),
- 18 years or more
- with a singleton live fetus at the routine ultrasound scan
- with a normal pregnancy.
Exclusion Criteria:
- Pregnancy complications
- Multiple pregnancy
- High risk for preterm labor
- Underlying diseases that could interfere with the results (such as pre-existing upper airway problems) and participation.
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
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
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Physiological modifications
Pregnant women who attend the routine ultrasound control in our institution before 14 weeks of pregnancy
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An acoustic reflection device gives the longitudinal cross-sectional area profile along airways.
It is based on the analysis of a planar acoustic wave propagating in a rigid duct connected to airway.
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MRI and acoustic
Women undergoing an MRI for obstetrical purpose
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An acoustic reflection device gives the longitudinal cross-sectional area profile along airways.
It is based on the analysis of a planar acoustic wave propagating in a rigid duct connected to airway.
|
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 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Physiological modifications during pregnancy and acoustic reflection method
時間枠：6 months
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Main aim: to evaluate by acoustic reflection method the physiological modifications of the upper airways during pregnancy. Women enrolled in the study will undergo an acoustic recording during:
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6 months
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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MRI and acoustic reflection method
時間枠：6 months
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Secondary aim: a single acoustic recording will be proposed to 10 pregnant women undergoing an MRI for obstetrical purpose. The estimated caliber of the upper airways by MRI and acoustic method will be compared. |
6 months
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協力者と研究者
捜査官
- スタディディレクター：Brigitte Fauroux, MD, PhD、Assistance Publique - Hôpitaux de Paris
- 主任研究者：Nicolas LEBOULANGER, MD、Assistance Publique - Hôpitaux de Paris
出版物と役立つリンク
一般刊行物
- Kodali BS, Chandrasekhar S, Bulich LN, Topulos GP, Datta S. Airway changes during labor and delivery. Anesthesiology. 2008 Mar;108(3):357-62. doi: 10.1097/ALN.0b013e31816452d3.
- Louis B, Fodil R, Jaber S, Pigeot J, Jarreau PH, Lofaso F, Isabey D. Dual assessment of airway area profile and respiratory input impedance from a single transient wave. J Appl Physiol (1985). 2001 Feb;90(2):630-7. doi: 10.1152/jappl.2001.90.2.630.
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
本研究に関する用語
キーワード
その他の研究ID番号
- MAVAG
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。
Acoustic reflection methodの臨床試験
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Zuyderland Medisch Centrum積極的、募集していない上肢骨折 | 橈骨遠位端骨折 | 上腕骨の近位端の骨折 | 上肢骨折オランダ
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Mississippi State UniversityAssociation for contextual behavioral scienceまだ募集していません
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Avacen, Inc.University of California, San Diego; San Diego Veterans Healthcare System完了
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SolitonUnited States Naval Medical Center, San Diegoまだ募集していません
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University of North Carolina, Chapel HillMed-El Corporation積極的、募集していない
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Assistance Publique - Hôpitaux de Paris募集再発した急性リンパ芽球性白血病 | B 急性リンパ芽球性白血病フランス