Evaluation of Positive Expiratory Pressure Device (PEP-device) for Treatment of 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
- 40
- 试验地点
- 2
- 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 treatment with positive expiratory pressure device (PEP-device) compared to spontaneous recovery in patients with SIPE without hypoxia 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 or without oxygen in combination with diuretics, beta-agonist-inhalation or continuous positive airway pressure (CPAP). Evidence for optimal treatment strategy is lacking. Oxygen treatment might not be appropriate for patients with SIPE presenting without hypoxia. It is unknown if positive airway pressure accelerates recovery in SIPE.
This study intends to determine whether treatment with positive expiratory pressure (PEP) applied by PEP-device accelerates increase of oxygen saturation compared to spontaneous recovery in patients presenting with SIPE without hypoxia. 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 and oxygen saturation ≥92% are randomly assigned to 2 groups: (1) PEP-device for 20 minutes or (2) control group with spontaneous recovery without active treatment for 20 minutes. Assessment with outcome measures is taken 10 minutes after intervention/control. 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
- •peripheral oxygen saturation ≥92%
- •18 years or older
- •informed consent
排除标准
- •declined consent
- •suspected acute coronary syndrome
- •severe asthma diagnosed together with pulmonary edema with requirement of beta-agonist-inhalation prior to treatment of pulmonary edema
- •hemodynamic instability or decreased consciousness
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
- Interstitial syndrome assessed by lung ultrasound (yes/no) after treatment(after 20 min treatment followed by 10 min rest)
- 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)
- Absolute number of regions presenting B-lines on lung ultrasound after treatment(after 20 min treatment followed by 10 min rest)
- Total treatment time(1 hour)
- 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)
- 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)(1 hour)
研究者
Maria Hårdstedt
Dr. Maria Hårdstedt, PhD, Specialist Internal Medicine
Dalarna County Council, Sweden