Dispositivo PEP per il trattamento dell'edema polmonare indotto dal nuoto (SIPE)
Valutazione del dispositivo a pressione espiratoria positiva (dispositivo PEP) per il trattamento dell'edema polmonare indotto dal nuoto (SIPE) - uno studio controllato randomizzato in singolo cieco
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.
Panoramica dello studio
Stato
Intervento / Trattamento
Descrizione dettagliata
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 di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Maria Hårdstedt, MD/PhD
- Numero di telefono: 46-738089464
- Email: maria.hardstedt@regiondalarna.se
Luoghi di studio
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Falun, Svezia, 79182
- Reclutamento
- Center of Clinical Research Dalarna
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Contatto:
- Maria Hårdstedt, MD/PhD
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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 |
|
Nessun intervento: spontaneous recovery
Control group: Resting and breathing air for 20 + 10 minutes. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Absolute peripheral oxygen saturation (%) after treatment
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change in absolute peripheral oxygen saturation (%) before and after treatment
Lasso di tempo: 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
|
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Recovery (yes/no) after treatment
Lasso di tempo: 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
Lasso di tempo: 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
|
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Absolute number of regions presenting B-lines on lung ultrasound after treatment
Lasso di tempo: 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
Lasso di tempo: 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
|
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Change in patient reported outcome measures before and after treatment
Lasso di tempo: 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
|
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Admission to hospital (yes/no)
Lasso di tempo: 1 hour
|
Admission to hospital within or after a maximal treatment time of 1 hour |
1 hour
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Total treatment time
Lasso di tempo: 1 hour
|
Total treatment time until oxygen saturation ≥96% is reached |
1 hour
|
Collaboratori e investigatori
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Inizio studio (Effettivo)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- SIPE PEP-device001
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