Dispositivo PEP para el tratamiento del edema pulmonar inducido por natación (SIPE)
Evaluación del dispositivo de presión espiratoria positiva (PEP-dispositivo) para el tratamiento del edema pulmonar inducido por la natación (SIPE): un estudio controlado aleatorio simple ciego
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.
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Maria Hårdstedt, MD/PhD
- Número de teléfono: 46-738089464
- Correo electrónico: maria.hardstedt@regiondalarna.se
Ubicaciones de estudio
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Falun, Suecia, 79182
- Reclutamiento
- Center of Clinical Research Dalarna
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Contacto:
- Maria Hårdstedt, MD/PhD
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- clinical diagnosis of swimming induced pulmonary edema (SIPE) with need of acute treatment
- peripheral oxygen saturation ≥92%
- 18 years or older
- informed consent
Exclusion Criteria:
- 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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: PEP-device
Positive expiratory pressure device: continuous treatment with PEP-device breathing air for 20 minutes followed by 10 minutes rest and assessment. Inspiration through nose/mouth, expiration through device. |
PEP-device |
|
Sin intervención: spontaneous recovery
Control group: Resting and breathing air for 20 + 10 minutes. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Absolute peripheral oxygen saturation (%) after treatment
Periodo de tiempo: 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
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in absolute peripheral oxygen saturation (%) before and after treatment
Periodo de tiempo: 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
Periodo de tiempo: 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
|
|
Interstitial syndrome assessed by lung ultrasound (yes/no) after treatment
Periodo de tiempo: 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
|
|
Absolute number of regions presenting B-lines on lung ultrasound after treatment
Periodo de tiempo: 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
Periodo de tiempo: 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
|
|
Change in patient reported outcome measures before and after treatment
Periodo de tiempo: change before versus after 20 min treatment followed by 10 min rest
|
Six different patient reported outcome measures assessed by numerical rating scale (NRS; min-max 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)
Periodo de tiempo: 1 hour
|
Admission to hospital within or after a maximal treatment time of 1 hour |
1 hour
|
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Total treatment time
Periodo de tiempo: 1 hour
|
Total treatment time until oxygen saturation ≥96% is reached |
1 hour
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- SIPE PEP-device001
Plan de datos de participantes individuales (IPD)
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Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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