NCT04307615

O2 Versus CPAP Treatment of Patients Undergoing SIPE Therapy (OCTOPUS)

Evaluation of Continous Positive Airway Pressure (CPAP) in Swimming Induced Pulmonary Edema (SIPE) -a Randomized Single-blinded Controlled Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Dalarna County Council, Sweden · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 continuous positive airway pressure (CPAP) compared to oxygen as a first line treatment of SIPE in the out-of-hospital environment.

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 oxygen alone or in combination with diuretics, beta-agonist-inhalation or continuous positive airway pressure (CPAP). Evidence for optimal treatment strategy is lacking. This study intends to determine whether oxygen alone or applied together with CPAP leads to improvement of oxygen saturation and recovery of patients. 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 are randomly assigned in 2 groups receiving treatment during 20 minutes: (1) oxygen 10l/min or (2) oxygen 10l/min and CPAP 7,5 cm H2O. Assessment with outcome measures is taken 10 minutes after treatment. Primary endpoint: oxygen saturation (%) by pulse oxymetry.

Conditions

• Swimming Induced Pulmonary Edema (SIPE)
• Pulmonary Edema
• Lung Diseases

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Oxygen + continuous positive airway pressure (CPAP)	Oxygen-driven CPAP (7,5 cmH2O): 20 min treatment followed by 10 min rest and assessment
DRUG	Oxygen	Oxygen: 20 min treatment followed by 10 min rest and assessment

Timeline

• Start date: 2022-07-02
• Primary completion: 2027-07-15
• Completion: 2027-07-15
• First posted: 2020-03-13
• Last updated: 2025-02-27

Locations

1 site across 1 country: Sweden