O2 Versus CPAP Treatment Of Patients Undergoing SIPE Therapy (OCTOPUS)
关键词
抽象
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 0,3%.
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.
日期
| 最后验证: | 02/29/2020 |
| 首次提交: | 02/03/2020 |
| 提交的预估入学人数: | 03/10/2020 |
| 首次发布: | 03/12/2020 |
| 上次提交的更新: | 03/10/2020 |
| 最近更新发布: | 03/12/2020 |
| 实际学习开始日期: | 07/02/2020 |
| 预计主要完成日期: | 07/14/2022 |
| 预计完成日期: | 07/14/2022 |
状况或疾病
干预/治疗
Combination Product: Oxygen + CPAP-treatment
Drug: Oxygen-treatment
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| Experimental: Oxygen + CPAP-treatment | Combination Product: Oxygen + CPAP-treatment Oxygen-driven CPAP (7,5 cmH2O): 20 min treatment followed by 10 min rest and assessment |
| Active Comparator: Oxygen-treatment | Drug: Oxygen-treatment Oxygen: 20 min treatment followed by 10 min rest and assessment |
资格标准
| 有资格学习的年龄 | 18 Years 至 18 Years |
| 有资格学习的性别 | All |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion Criteria: - clinical diagnosis of swimming induced pulmonary edema (SIPE) with need of acute treatment (oxygen saturation ≤95%) - 18 years and older - informed consent Exclusion Criteria: - declined consent - SIPE without need of acute treatment (oxygen saturation >95%) - 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 |
结果
主要结果指标
1. Absolute peripheral oxygen saturation (%) after treatment [after 20 min treatment followed by 10 min rest]
次要成果指标
1. Change in absolute peripheral oxygen saturation (%) before and after treatment [change before versus after 20 min treatment followed by 10 min rest]
2. Recovery (yes/no) after treatment [after 20 min treatment followed by 10 min rest]
3. Interstitial syndrome assessed by lung ultrasound (yes/no) after treatment [after 20 min treatment followed by 10 min rest]
4. Absolute number of regions presenting B-lines on lung ultrasound after treatment [after 20 min treatment followed by 10 min rest]
5. 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]
6. Auscultation findings of crackles (yes/no) after treatment [after 20 min treatment followed by 10 min rest]
7. Change in individual assessment of symptoms before and after treatment [change before versus after 20 min treatment followed by 10 min rest]
