Comparing oxygen and CPAP for treating swimming induced pulmonary edema
Evaluation of Continous Positive Airway Pressure (CPAP) in Swimming Induced Pulmonary Edema (SIPE) -a Randomized Single-blinded Controlled Study
This study tests whether using CPAP along with oxygen helps swimmers with swimming induced pulmonary edema feel better than just using oxygen alone.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Dalarna County Council, Sweden Academic / other |
| Locations | 1 site (Falun) |
| Trial ID | NCT04307615 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of continuous positive airway pressure (CPAP) compared to oxygen alone as a first-line treatment for swimming induced pulmonary edema (SIPE) in an out-of-hospital setting. It involves a large cohort of approximately 12,000 swimmers during Sweden's Vansbrosimningen event, where participants diagnosed with SIPE will receive either oxygen or oxygen with CPAP for 20 minutes. The primary outcome measure is the improvement in oxygen saturation assessed 10 minutes post-treatment. The goal is to provide effective treatment on-site, potentially reducing the need for emergency care.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are clinically diagnosed with SIPE and require acute treatment.
Not a fit: Patients with suspected acute coronary syndrome, severe asthma requiring beta-agonist treatment, or those who are hemodynamically unstable or have decreased consciousness may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective treatment option for swimmers experiencing SIPE, improving patient outcomes and reducing emergency interventions.
How similar studies have performed: While there is limited evidence on optimal treatment strategies for SIPE, this approach of comparing oxygen and CPAP is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * clinical diagnosis of swimming induced pulmonary edema (SIPE) with need of acute treatment (oxygen saturation ≤91%) * 18 years and older * informed consent Exclusion Criteria: * declined consent * suspected acute coronary syndrome * severe asthma diagnosed together with pulmonary edema where beta-agonist-inhalation is needed prior to treatment of pulmonary edema * hemodynamic instability or decreased consciousness
Where this trial is running
Falun
- Center of Clinical Research Dalarna — Falun, Sweden (Recruiting)
Study contacts
- Study coordinator: Maria Hårdstedt, MD/PhD
- Email: maria.hardstedt@regiondalarna.se
- Phone: 46-738089464
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.