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

Last updated: February 25, 2025
Sponsor: Dalarna County Council, Sweden
Overall Status: Active - Recruiting

Phase

N/A

Condition

Lung Disease

Lung Injury

Treatment

Oxygen + continuous positive airway pressure (CPAP)

Oxygen

Clinical Study ID

NCT04307615
OCTOPUS001
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • clinical diagnosis of swimming induced pulmonary edema (SIPE) with need of acutetreatment (oxygen saturation ≤91%)

  • 18 years and older

  • informed consent

Exclusion

Exclusion Criteria:

  • declined consent

  • suspected acute coronary syndrome

  • severe asthma diagnosed together with pulmonary edema where beta-agonist-inhalationis needed prior to treatment of pulmonary edema

  • hemodynamic instability or decreased consciousness

Study Design

Total Participants: 90
Treatment Group(s): 2
Primary Treatment: Oxygen + continuous positive airway pressure (CPAP)
Phase:
Study Start date:
July 02, 2022
Estimated Completion Date:
July 15, 2027

Study 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.

Connect with a study center

  • Center of Clinical Research Dalarna

    Falun, 79182
    Sweden

    Active - Recruiting

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