O2 Versus CPAP Treatment Of Patients Undergoing SIPE Therapy (OCTOPUS) (OCTOPUS)
水泳誘発性肺水腫 (SIPE) における持続気道陽圧 (CPAP) の評価 - 無作為化単一盲検対照研究
In swimming induced pulmonary edema (SIPE), there is a lack of knowledge regarding optimal treatment. The present study was designed to assess the benefit of continuous positive airway pressure (CPAP) compared to oxygen as a first line treatment of SIPE in the out-of-hospital environment.
調査の概要
状態
詳細な説明
Swimming induced pulmonary edema (SIPE) is an unusual condition affecting otherwise healthy swimmers. SIPE is characterized by acute onset of dyspnea and cough, excessive sputum and occasionally hemoptysis when swimming in open water. The condition usually resolves spontaneously within 48 hours, but may result in serious illness and require emergency care. Case reports describe acute treatment with oxygen alone or in combination with diuretics, beta-agonist-inhalation or continuous positive airway pressure (CPAP). Evidence for optimal treatment strategy is lacking. This study intends to determine whether oxygen alone or applied together with CPAP leads to improvement of oxygen saturation and recovery of patients. The aim is to treat patients on site without involving hospital care. We study a large cohort of approximately 12 000 swimmers during Vansbrosimningen, Sweden's biggest annual open water event with a yearly incidence of SIPE about 0,4%.
Adult patients clinically diagnosed with SIPE are randomly assigned in 2 groups receiving treatment during 20 minutes: (1) oxygen 10l/min or (2) oxygen 10l/min and CPAP 7,5 cm H2O. Assessment with outcome measures is taken 10 minutes after treatment. Primary endpoint: oxygen saturation (%) by pulse oxymetry.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Maria Hårdstedt, MD/PhD
- 電話番号：46-738089464
- メール：maria.hardstedt@regiondalarna.se
研究場所
-
-
-
Falun、スウェーデン、79182
- 募集
- Center of Clinical Research Dalarna
-
-
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:
- clinical diagnosis of swimming induced pulmonary edema (SIPE) with need of acute treatment (oxygen saturation ≤91%)
- 18 years and older
- informed consent
Exclusion Criteria:
- declined consent
- suspected acute coronary syndrome
- severe asthma diagnosed together with pulmonary edema where beta-agonist-inhalation is needed prior to treatment of pulmonary edema
- hemodynamic instability or decreased consciousness
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：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：酸素 + CPAP 治療
|
Oxygen-driven CPAP (7,5 cmH2O): 20 min treatment followed by 10 min rest and assessment |
|
アクティブコンパレータ：酸素処理
|
Oxygen: 20 min treatment followed by 10 min rest and assessment |
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 |
|---|---|---|
|
Absolute peripheral oxygen saturation (%) after treatment
時間枠：after 20 min treatment followed by 10 min rest
|
Peripheral oxygen saturation % (continuous variable) measured by peripheral pulse oximetry |
after 20 min treatment followed by 10 min rest
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in absolute peripheral oxygen saturation (%) before and after treatment
時間枠：change before versus after 20 min treatment followed by 10 min rest
|
Change in peripheral oxygen saturation % (continuous variable) measured by pulse oximetry before and after treatment |
change before versus after 20 min treatment followed by 10 min rest
|
|
Recovery (yes/no) after treatment
時間枠：after 20 min treatment followed by 10 min rest
|
Recovery, defined by "peripheral oxygen saturation >95% after treatment" or no recovery, defined by "peripheral oxygen saturation ≤95% after treatment" |
after 20 min treatment followed by 10 min rest
|
|
Absolute number of regions presenting B-lines on lung ultrasound after treatment
時間枠：after 20 min treatment followed by 10 min rest
|
Four chest regions for both lungs are scanned by lung ultrasound; a positive region defined by the presence of three or more B-line artifacts. Assessment of the total number of positive regions. |
after 20 min treatment followed by 10 min rest
|
|
Change in absolute number of regions presenting B-lines on lung ultrasound before and after treatment
時間枠：change before versus after 20 min treatment followed by 10 min rest
|
Four chest regions for both lungs are scanned by lung ultrasound; a positive region defined by the presence of three or more B-line artifacts. Assessment of the total number of positive regions. Change in absolute number of regions presenting B-lines on lung ultrasound before and after treatment |
change before versus after 20 min treatment followed by 10 min rest
|
|
Interstitial syndrome assessed by lung ultrasound (yes/no) after treatment
時間枠：after 20 min treatment followed by 10 min rest
|
Four chest regions for both lungs are scanned by lung ultrasound; a positive region defined by the presence of three or more B-line artifacts. Bilateral or unilateral presence of two or more positive regions define positive interstitial syndrome. |
after 20 min treatment followed by 10 min rest
|
|
Change in patient reported outcome measures before and after treatment
時間枠：change before versus after 20 min treatment followed by 10 min rest
|
Six different patient reported outcome measures assessed by numeric rating scale (NRS) 0-10: cough, sputum, air hunger, breathing effort, tightness in chest, anxiousness. The patients will assess symptoms prior to and after treatment. |
change before versus after 20 min treatment followed by 10 min rest
|
|
Admission to hospital (yes/no)
時間枠：2 hours
|
admission to hospital within or after a maximal treatment time of 40 minutes followed by 20 min rest. |
2 hours
|
|
total treatment time
時間枠：2 hours
|
total treatment time until oxygen saturation ≥96% is reached. |
2 hours
|
|
subgroup analysis
時間枠：1 hour
|
treatment outcome analysis in patients with different baseline oxygen saturation on admission |
1 hour
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
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 (実際)
学習記録の更新
投稿された最後の更新 (実際)
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
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