Swimming Induced Pulmonary Edema (SIPE)NCT05227222
PEP-device for Treatment of Swimming-induced Pulmonary Edema (SIPE)
A study testing PEP-device in people with Swimming Induced Pulmonary Edema (SIPE) and Pulmonary Edema, run by Dalarna County Council, Sweden at 1 site in Sweden.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Swimming Induced Pulmonary Edema (SIPE), Pulmonary Edema, Lung Diseases
- What is being tested?
- PEP-device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSweden
- Study dates
- 2 Jul 2022to 15 Jul 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- clinical diagnosis of swimming induced pulmonary edema (SIPE) with need of acute treatment
- peripheral oxygen saturation ≥92%
- 18 years or older
- informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Center of Clinical Research Dalarna
Falun, 79182
Maria Hårdstedt, MD/PhD
About this study
Official title: Evaluation of Positive Expiratory Pressure Device (PEP-device) for Treatment of Swimming Induced Pulmonary Edema (SIPE) - a Randomized Single-blinded Controlled Study
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.
Read the detailed description
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.
- Being tested
- PEP-device
- Keywords
- positive expiratory pressure, therapeutics, ultrasonography, oximetry
- Medical subject headings
- Pulmonary Edema, Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEP-deviceDevice
PEP-device
| Study group | Role | What they receive |
|---|---|---|
| PEP-device | Experimental | 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. Receives: Device: PEP-device |
| spontaneous recovery | No intervention | Control group: Resting and breathing air for 20 + 10 minutes. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute peripheral oxygen saturation (%) after treatment
Peripheral oxygen saturation % (continuous variable) measured by peripheral pulse oximetry
Measured: after 20 min treatment followed by 10 min rest
Secondary outcomes (8)
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
Measured: 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"
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 1 hour
Total treatment time
Total treatment time until oxygen saturation ≥96% is reached
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2022
- Study start2 Jul 2022
- Primary completion15 Jul 2027 (estimated)
- Study completion15 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Swimming Induced Pulmonary Edema (SIPE)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dalarna County Council, Sweden
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Hårdstedt, Dalarna County Council, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05227222
- Sponsor's protocol ID
- SIPE PEP-device001
- Status last verified
- Sep 2026
- First submitted
- 26 Jan 2022
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No