O2 Versus CPAP Treatment of Patients Undergoing SIPE Therapy (OCTOPUS)
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Oxygen + continuous positive airway pressure (CPAP), Oxygen.
- Кому может быть актуально
- Состояния в реестре: Swimming Induced Pulmonary Edema (SIPE), Pulmonary Edema, Lung Diseases. Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Швеция
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Evaluation of Continous Positive Airway Pressure (CPAP) in Swimming Induced Pulmonary Edema (SIPE) -a Randomized Single-blinded Controlled Study
Обзор
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.
Подробное описание
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.
Вмешательства
- Комбинированный продукт Oxygen + continuous positive airway pressure (CPAP)
Oxygen-driven CPAP (7,5 cmH2O): 20 min treatment followed by 10 min rest and assessment - Препарат Oxygen
Oxygen: 20 min treatment followed by 10 min rest and assessment
Первичные конечные точки
- Absolute peripheral oxygen saturation (%) after treatment [Срок оценки: after 20 min treatment followed by 10 min rest]
Вторичные конечные точки (9)
- Change in absolute peripheral oxygen saturation (%) before and after treatment [Срок оценки: change before versus after 20 min treatment followed by 10 min rest]
- Recovery (yes/no) after treatment [Срок оценки: after 20 min treatment followed by 10 min rest]
- Interstitial syndrome assessed by lung ultrasound (yes/no) after treatment [Срок оценки: after 20 min treatment followed by 10 min rest]
- Absolute number of regions presenting B-lines on lung ultrasound after treatment [Срок оценки: 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 [Срок оценки: change before versus after 20 min treatment followed by 10 min rest]
- Change in patient reported outcome measures before and after treatment [Срок оценки: change before versus after 20 min treatment followed by 10 min rest]
- Admission to hospital (yes/no) [Срок оценки: 2 hours]
- total treatment time [Срок оценки: 2 hours]
- subgroup analysis [Срок оценки: 1 hour]
Критерии участия
Критерии включения
- clinical diagnosis of swimming induced pulmonary edema (SIPE) with need of acute treatment (oxygen saturation ≤91%)
- 18 years and older
- informed consent
Критерии исключения
- 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
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Двойное слепое
- Основная цель
- Лечение
Центры проведения
Швеция · 1 центр
- Center of Clinical Research Dalarna — Falun
Идентификаторы
NCT: NCT04307615 · OCTOPUS001