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

Study Overview
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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.

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.

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

Conditions
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Swimming Induced Pulmonary Edema (SIPE), Pulmonary Edema, Lung Diseases

Intervention / Treatment
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* Combination Product: Oxygen + continuous positive airway pressure (CPAP)
* Drug: Oxygen


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oxygen + CPAP-treatment<br> | Combination Product: Oxygen + continuous positive airway pressure (CPAP)<br>* Oxygen-driven CPAP (7,5 cmH2O): 20 min treatment followed by 10 min rest and assessment<br>|
| Active Comparator: Oxygen-treatment<br> | Drug: Oxygen<br>* Oxygen: 20 min treatment followed by 10 min rest and assessment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absolute peripheral oxygen saturation (%) after treatment | Peripheral oxygen saturation % (continuous variable) measured by peripheral pulse oximetry | after 20 min treatment followed by 10 min rest | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in absolute peripheral oxygen saturation (%) before and after treatment | Change in peripheral oxygen saturation % (continuous variable) measured by pulse oximetry before and after treatment | change before versus after 20 min treatment followed by 10 min rest | 
| Recovery (yes/no) after treatment | Recovery, defined by peripheral oxygen saturation >95% after treatment or no recovery, defined by peripheral oxygen saturation ≤95% after treatment | after 20 min treatment followed by 10 min rest | 
| Interstitial syndrome assessed by lung ultrasound (yes/no) after treatment | Four chest regions for both lungs are scanned by lung ultrasound; a positive region defined by the presence of three or more B-line artifacts. Bilateral or unilateral presence of two or more positive regions define positive interstitial syndrome. | after 20 min treatment followed by 10 min rest | 
| Absolute number of regions presenting B-lines on lung ultrasound after treatment | Four chest regions for both lungs are scanned by lung ultrasound; a positive region defined by the presence of three or more B-line artifacts. Assessment of the total number of positive regions. | after 20 min treatment followed by 10 min rest | 
| Change in absolute number of regions presenting B-lines on lung ultrasound before and after treatment | Four chest regions for both lungs are scanned by lung ultrasound; a positive region defined by the presence of three or more B-line artifacts. Assessment of the total number of positive regions. Change in absolute number of regions presenting B-lines on lung ultrasound before and after treatment | change before versus after 20 min treatment followed by 10 min rest | 
| Change in patient reported outcome measures before and after treatment | Six different patient reported outcome measures assessed by numeric rating scale (NRS) 0-10: cough, sputum, air hunger, breathing effort, tightness in chest, anxiousness. The patients will assess symptoms prior to and after treatment. | change before versus after 20 min treatment followed by 10 min rest | 
| Admission to hospital (yes/no) | admission to hospital within or after a maximal treatment time of 40 minutes followed by 20 min rest. | 2 hours | 
| total treatment time | total treatment time until oxygen saturation ≥96% is reached. | 2 hours | 
| subgroup analysis | treatment outcome analysis in patients with different baseline oxygen saturation on admission | 1 hour | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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continuous positive airway pressure (CPAP), oxygen, therapeutics, ultrasonography, oximetry