O2 Versus CPAP Treatment Of Patients Undergoing SIPE Therapy (OCTOPUS) (OCTOPUS)
持续气道正压通气 (CPAP) 在游泳引起的肺水肿 (SIPE) 中的评估 - 一项随机单盲对照研究
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.
研究概览
地位
详细说明
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.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Maria Hårdstedt, MD/PhD
- 电话号码：46-738089464
- 邮箱：maria.hardstedt@regiondalarna.se
学习地点
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-
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Falun、瑞典、79182
- 招聘中
- Center of Clinical Research Dalarna
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
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
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：氧气 + CPAP 治疗
|
Oxygen-driven CPAP (7,5 cmH2O): 20 min treatment followed by 10 min rest and assessment |
|
有源比较器：氧疗
|
Oxygen: 20 min treatment followed by 10 min rest and assessment |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Absolute peripheral oxygen saturation (%) after treatment
大体时间：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
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in absolute peripheral oxygen saturation (%) before and after treatment
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
|
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Change in patient reported outcome measures before and after treatment
大体时间：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)
大体时间：2 hours
|
admission to hospital within or after a maximal treatment time of 40 minutes followed by 20 min rest. |
2 hours
|
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total treatment time
大体时间：2 hours
|
total treatment time until oxygen saturation ≥96% is reached. |
2 hours
|
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subgroup analysis
大体时间：1 hour
|
treatment outcome analysis in patients with different baseline oxygen saturation on admission |
1 hour
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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