Using a PEP-device to treat swimming-induced pulmonary edema
Official title: Evaluation of Positive Expiratory Pressure Device (PEP-device) for Treatment of Swimming Induced Pulmonary Edema (SIPE) - a Randomized Single-blinded Controlled Study
Run by Dalarna County Council, Sweden · NCT05227222 · Data updated 2026-11-12
This study is testing if using a special breathing device for 20 minutes can help swimmers recover faster from swimming-induced pulmonary edema compared to not using the device.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | Dalarna County Council, Sweden Academic / other |
| Locations | 1 site (Falun) |
| Status | Recruiting |
| Started | July 2, 2022 |
| Main results expected | July 15, 2027 |
| Study ends | July 15, 2027 |
| Registry record updated | October 5, 2026 |
| Trial ID | NCT05227222 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older who have a clinical diagnosis of SIPE and an oxygen saturation of 92% or higher.
✕Probably not a fit
Patients with severe asthma requiring beta-agonist treatment, suspected acute coronary syndrome, or those who are hemodynamically unstable will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates the effectiveness of a positive expiratory pressure (PEP) device in treating swimming-induced pulmonary edema (SIPE) in patients who are not hypoxic. It aims to determine if using the PEP-device for 20 minutes can accelerate recovery compared to spontaneous recovery in a large cohort of swimmers during a major open water event in Sweden. Participants will be randomly assigned to either receive treatment with the PEP-device or to a control group with no active treatment, with outcomes assessed shortly after. The goal is to provide an effective treatment option for SIPE that can be administered outside of a hospital setting.
Why it matters
Potential benefit: If successful, this treatment could provide a rapid and effective way to manage SIPE, reducing the need for emergency care.
How similar studies have gone: While there is limited evidence on the optimal treatment for SIPE, this approach using a PEP-device is novel and has not been extensively tested in similar studies.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Center of Clinical Research Dalarna
Falun, Sweden Recruiting
Study contacts
- Study coordinator: Maria Hårdstedt, MD/PhD
- Email: maria.hardstedt@regiondalarna.se
- Phone: 46-738089464
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.