Evaluation of Continous Positive Airway Pressure (CPAP) in Swimming Induced Pulmonary Edema (SIPE) -a Randomized Single-blinded Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Absolute peripheral oxygen saturation (%) after treatment
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •clinical diagnosis of swimming induced pulmonary edema (SIPE) with need of acute treatment (oxygen saturation ≤91%)
- •18 years and older
- •informed consent
排除标准
- •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
研究组 & 干预措施
Oxygen + CPAP-treatment
干预措施: Oxygen + continuous positive airway pressure (CPAP) (Combination Product)
Oxygen-treatment
干预措施: Oxygen (Drug)
结局指标
主要结局
Absolute peripheral oxygen saturation (%) after treatment
时间窗: after 20 min treatment followed by 10 min rest
Peripheral oxygen saturation % (continuous variable) measured by peripheral pulse oximetry
次要结局
- Absolute number of regions presenting B-lines on lung ultrasound after treatment(after 20 min treatment followed by 10 min rest)
- Change in patient reported outcome measures before and after treatment(change before versus after 20 min treatment followed by 10 min rest)
- Admission to hospital (yes/no)(2 hours)
- Change in absolute peripheral oxygen saturation (%) before and after treatment(change before versus after 20 min treatment followed by 10 min rest)
- Recovery (yes/no) after treatment(after 20 min treatment followed by 10 min rest)
- Interstitial syndrome assessed by lung ultrasound (yes/no) after treatment(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(change before versus after 20 min treatment followed by 10 min rest)
- total treatment time(2 hours)
- subgroup analysis(1 hour)
研究者
Maria Hårdstedt
Dr. Maria Hårdstedt, PhD, Specialist Internal Medicine
Dalarna County Council, Sweden