Effect of Hyperoxia and Hypergravity on Lung Ventilation and Perfusion
Influence of Hyperoxia and Hypergravity on Pulmonary Ventilation and Perfusion
調査の概要
詳細な説明
Experiments were conducted in a human centrifuge. The protocol aimed at mimicking a routine peacetime flight in combat aircraft, and included 10-min exposure to +1.4 - +3.5 Gz. Subjects were exposed three times to this sequence, breathing air, 44.5% O2 or 100% O2.
Ten volunteers wearing anti-G trousers participated in the study. The Ethics Committee Ile-de-France III and the French National Agency for Drug Safety (ANSM) approved the protocol (number 2009-A01092-55).
Three different imaging techniques, electrical impedance tomography (EIT), pulmonary ultrasound and chest SPECT/CT were used and compared. EIT enabled ventilation monitoring in the human centrifuge, whereas pulmonary ultrasound and SPECT/CT gave functional and topographical information before and after exposure to +Gz accelerations. EIT analysis focused on regional ventilation, SPECT on global lung ventilation and perfusion, CT on the presence of atelectasis, and pulmonary ultrasound analysis looked for comet tails in 64 chest areas. Arterial blood pressure was recorded continuously by finger photoplethysmography. Cardiac output and stroke volume were computed from these recordings, using three different algorithms. Echocardiography was used as reference non-invasive technique for stroke volume determination and performed before and after exposure to +Gz accelerations.
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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-
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Brétigny-sur-Orge、フランス、91 223
- Armed Forces Biomedical Research Institute
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Paris、フランス、75005
- Department of Nuclear Medicine, Val-de-Grâce 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
説明
Inclusion Criteria:
- normal lung function checked by pulmonary function tests
Part 1 exclusion Criteria:
- past medical history of heart or lung disease
- current medical treatment for heart or lung disease
- smoking
- bad tolerance to +Gz accelerations (G-induced loss of consciousness, motion sickness)
Part 2 exclusion criteria:
- past medical history of heart or lung disease
- current medical treatment for heart or lung disease
- smoking
- The use of medication for hypertension
- asymmetric values of left/right humeral arterial blood pressure
- significant echocardiographic abnormalities or bad echogenicity
- bad tolerance to +Gz accelerations (G-induced loss of consciousness, motion sickness)
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：基礎科学
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：ventilation
hypergravity gas mixture
|
1hr sitting rest followed by 10 min of hypergravity (2 centrifuge runs)
breathing air, 44.5%O2 or 100%O2
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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 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
change in regional ventilation distribution
時間枠：baseline, 2hrs 30min
|
"per lobe and per quadrant at 5th intercostal space level"
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baseline, 2hrs 30min
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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 |
|---|---|---|
|
change in regional pulmonary perfusion
時間枠：baseline, 2hrs 30min
|
"per lobe and per quadrant at 5th intercostal space level"
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baseline, 2hrs 30min
|
|
cardiac output (L/min)
時間枠：2hrs
|
"echocardiography (sub-aortic diameter), photoplethysmography (Liljestrand, systolic area and Windkessel algorithms)"
|
2hrs
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
tidal volume
時間枠：2hrs 30min
|
global (mL, area under the flow versus time curve) and regional (% change per quadrant at 5th intercostal space level)
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2hrs 30min
|
協力者と研究者
捜査官
- スタディチェア：Daniel Garin, MD, PhD、Armed Forces Biomedical Research Institute
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。