RecruitingNot Applicable

PEP-device for Treatment of Swimming-induced Pulmonary Edema (SIPE)

Sweden40 participantsStarted 2022-07-02

Plain-language summary

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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Absolute peripheral oxygen saturation (%) after treatment

Timeframe: after 20 min treatment followed by 10 min rest

Trial details

NCT IDNCT05227222

SponsorDalarna County Council, Sweden

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-07-15

Contact for this trial

Maria Hårdstedt, MD/PhD

46-738089464 maria.hardstedt@regiondalarna.se

View on ClinicalTrials.gov More Swimming Induced Pulmonary Edema (SIPE) trials