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Clinical trial

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

ID
Name
OCTOPUS001
Description
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.
Trial arms
Trial start
2022-07-02
Estimated PCD
2025-07-15
Trial end
2025-07-15
Status
Recruiting
Treatment
Oxygen + continuous positive airway pressure (CPAP)
Oxygen-driven CPAP (7,5 cmH2O): 20 min treatment followed by 10 min rest and assessment
Arms:
Oxygen + CPAP-treatment
Oxygen
Oxygen: 20 min treatment followed by 10 min rest and assessment
Arms:
Oxygen-treatment
Size
90
Primary endpoint
Absolute peripheral oxygen saturation (%) after treatment
after 20 min treatment followed by 10 min rest
Eligibility criteria
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 90, 'type': 'ESTIMATED'}}
Updated at
2024-01-10

1 organization

2 products

3 indications

Organization
Dalarna County Council
Product
Oxygen + CPAP
Indication
Swimming Induced Pulmonary Edema
Indication
Pulmonary Edema
Indication
Lung Diseases
Product
Oxygen