Acute Lung Injury in Children: Epidemiology and Natural History. PEDIATRIC ALIEN. (ALIEN)
Acute Lung Injury in Spanish Children
調査の概要
詳細な説明
Acute lung injury (ALI) is a clinical syndrome of rapid onset of non-cardiogenic pulmonary edema manifested clinically by hypoxemia (PaO2/FiO2≤300 mmHg) and bilateral pulmonary infiltrates. When the hypoxemia is severe (PaO2/FiO2≤200 mmHg) it is termed the acute respiratory distress syndrome (ARDS). It represents a significant public health issue. Patients with ALI or ARDS require admission into critical care units for advanced life support and utilize considerable health care resources.
An immense plethora of translational knowledge has been acquired since the first description of ARDS in 1967. At the present, estimates of the incidence of ARDS and ALI in children are unknown. In adults, the estimates of ALI/ARDS incidence have varied widely, and the true magnitude of this health problem still remains unclear. Current estimates of the incidence of adult ALI/ARDS range from 15 to 80 cases per 100.000 population, or almost 40.000 cases per year in Spain. Combined mortality rates for adult ALI/ARDS range between 30-45% but it is not clear whether this figures can be translated in the pediatric population. ALI and ARDS occur as a complication or as the primary cause of critical illness in patients, usually after severe infection or trauma.
Published epidemiological studies on ALI and ARDS in the last 20 years are difficult to compare. Some reports have used different definitions for ALI and ARDS and others have evaluated the incidence during a short period of time (from days to several weeks) and then extrapolated their data to estimates of a one-year incidence. Very few studies have collected information for an entire year, and none of them have evaluated the degree of hypoxemia under standard ventilatory settings, as it has been proposed recently by the HELP Network (Am J Respir Crit Care Med 2007; 176:795-804).
研究の種類
入学 (予想される)
連絡先と場所
研究連絡先
- 名前:Yolanda M Lopez, Pediatrician
- 電話番号:6312 0034946006000
- メール:yolandamarg.lopezfernandez@osakidetza.net
研究連絡先のバックアップ
- 名前:Amelia Martinez de Azagra, Pediatrician
- 電話番号:0034915035929
- メール:amartinez.hnjs@salud.madrid.org
研究場所
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Vizcaya
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Baracaldo、Vizcaya、スペイン、48903
- 募集
- Cruces Hospital
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コンタクト:
- Yolanda M Lopez, Pediatrician
- 電話番号:6312 0034946006000
- メール:yolandamarg.lopezfernandez@osakidetza.net
-
コンタクト:
- Amelia Martinez de Azagra, Pediatrician
- 電話番号:0034915035929
- メール:amartinez.hnjs@salud.madrid.org
-
副調査官:
- Yolanda M Lopez, Pediatrician
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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:
- All patients, age ranging from 1 month to 15 years old
- Must be able to meet the American European Consensus definition of ALI and ARDS(no indication of heart failure or a pulmonary capillary wedge pressure of greater than 18 mmHg, with pulmonary infiltrates in all four quadrants and a PaO2/FIO2 of > 200 to <300 mmHg (ALI) or ? 200 mmHg (ARDS).
Exclusion criteria:
- Younger than 1 month or older than 15 years old
- Cardiac disease
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
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 |
---|---|
1. Incidence of Pediatric ALI, ARDS and non-ALI/ARDS in Spain based on the AECC and HELP criteria.
時間枠:One year
|
One year
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Risk factors and causes of ALI/ARDS
時間枠:One year
|
|
One year
|
協力者と研究者
スポンサー
捜査官
- 主任研究者:Kacmarec and Villar Robert and Jesus, Physicians、Spanish Intensive Care
研究記録日
主要日程の研究
研究開始
一次修了 (予想される)
研究の完了 (予想される)
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。