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

Dalarna County Council, Sweden

Status: Enrolling

Conditions: Lung Diseases; Swimming Induced Pulmonary Edema (SIPE); Pulmonary Edema

Treatments: Drug: Oxygen; Combination Product: Oxygen + continuous positive airway pressure (CPAP)

Study type: Interventional

Funder types: Other

Identifiers

NCT04307615

OCTOPUS001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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90 participants in 2 patient groups

Oxygen + CPAP-treatment

Experimental group

Treatment:

Combination Product: Oxygen + continuous positive airway pressure (CPAP)

Oxygen-treatment

Active Comparator group

Treatment:

Drug: Oxygen