Evaluation of Positive Expiratory Pressure Device (PEP-device) for Treatment of Swimming Induced Pulmonary Edema (SIPE) - a Randomized Single-blinded Controlled Study
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• clinical diagnosis of swimming induced pulmonary edema (SIPE) with need of acute treatment
• peripheral oxygen saturation ≥92%
• 18 years or older
• informed consent
Locations
Other Locations
Sweden
Center of Clinical Research Dalarna
RECRUITING
Falun
Contact Information
Primary
Maria Hårdstedt, MD/PhD
maria.hardstedt@regiondalarna.se
46-738089464
Time Frame
Start Date: 2022-07-02
Estimated Completion Date: 2027-07-15
Participants
Target number of participants: 40
Treatments
Experimental: PEP-device
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.
No_intervention: spontaneous recovery
Control group: Resting and breathing air for 20 + 10 minutes.
Related Therapeutic Areas
Sponsors
Leads: Dalarna County Council, Sweden