An interventional study of PEP-device in Swimming Induced Pulmonary Edema (SIPE), Pulmonary Edema and Lung Diseases, sponsored by Dalarna County Council, Sweden. Recruiting at 1 site in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-05.
Sponsored by Dalarna County Council, Sweden · Not applicable, Interventional, and Treatment
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.
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.
126 studies on the registry are indexed under Pulmonary Edema; 27 are open to participants now.
This study's planned enrollment of 40 is below the median of 65 across 62 interventional studies indexed under Pulmonary Edema.
Browse Pulmonary Edema studies →Dalarna County Council, Sweden is the lead sponsor of 28 studies on the registry; 10 are open to participants now.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: PEP-device
Control group: Resting and breathing air for 20 + 10 minutes.
PEP-device
Absolute peripheral oxygen saturation (%) after treatment
Peripheral oxygen saturation % (continuous variable) measured by peripheral pulse oximetry
Time frame: after 20 min treatment followed by 10 min rest
Change in absolute peripheral oxygen saturation (%) before and after treatment
Change in peripheral oxygen saturation % (continuous variable) measured by pulse oximetry before and after treatment
Time frame: change before versus after 20 min treatment followed by 10 min rest
Recovery (yes/no) after treatment
Recovery, defined by "peripheral oxygen saturation \>95% after treatment" or no recovery, defined by "peripheral oxygen saturation ≤95% after treatment"
Time frame: after 20 min treatment followed by 10 min rest
Interstitial syndrome assessed by lung ultrasound (yes/no) after treatment
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
Time frame: after 20 min treatment followed by 10 min rest
Absolute number of regions presenting B-lines on lung ultrasound after treatment
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.
Time frame: 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
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
Time frame: change before versus after 20 min treatment followed by 10 min rest
Change in patient reported outcome measures before and after treatment
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
Time frame: change before versus after 20 min treatment followed by 10 min rest
Admission to hospital (yes/no)
Admission to hospital within or after a maximal treatment time of 1 hour
Time frame: 1 hour
Total treatment time
Total treatment time until oxygen saturation ≥96% is reached
Time frame: 1 hour
Plan to share: No
No publications or documents are linked to this record.
Started Jul 2022 (actual). Primary completion is estimated for Jul 2027, 60 months after the start.
Of 22 interventional studies with no phase under Pulmonary Edema, half reached primary completion within 39 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 69. This study's planned 60 months is above that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Dalarna County Council, Sweden