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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-02

Study Completion Date

2027-07-15

Brief Summary

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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.

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Detailed Description

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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

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Swimming Induced Pulmonary Edema (SIPE) Pulmonary Edema Lung Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Oxygen + CPAP-treatment

Group Type EXPERIMENTAL

Oxygen + continuous positive airway pressure (CPAP)

Intervention Type COMBINATION_PRODUCT

Oxygen-driven CPAP (7,5 cmH2O): 20 min treatment followed by 10 min rest and assessment

Oxygen-treatment

Group Type ACTIVE_COMPARATOR

Oxygen

Intervention Type DRUG

Oxygen: 20 min treatment followed by 10 min rest and assessment

Interventions

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Oxygen + continuous positive airway pressure (CPAP)

Oxygen-driven CPAP (7,5 cmH2O): 20 min treatment followed by 10 min rest and assessment

Intervention Type COMBINATION_PRODUCT

Oxygen

Oxygen: 20 min treatment followed by 10 min rest and assessment

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No