PEP-device for Treatment of Swimming-induced Pulmonary Edema (SIPE)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: PEP-device.
- Who it may be relevant to
- Registry conditions: Swimming Induced Pulmonary Edema (SIPE), Pulmonary Edema, Lung Diseases. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Sweden
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluation of Positive Expiratory Pressure Device (PEP-device) for Treatment of Swimming Induced Pulmonary Edema (SIPE) - a Randomized Single-blinded Controlled Study
Overview
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 treatment with positive expiratory pressure device (PEP-device) compared to spontaneous recovery in patients with SIPE without hypoxia in the out-of-hospital environment.
Detailed 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 or without oxygen in combination with diuretics, beta-agonist-inhalation or continuous positive airway pressure (CPAP). Evidence for optimal treatment strategy is lacking. Oxygen treatment might not be appropriate for patients with SIPE presenting without hypoxia. It is unknown if positive airway pressure accelerates recovery in SIPE.
This study intends to determine whether treatment with positive expiratory pressure (PEP) applied by PEP-device accelerates increase of oxygen saturation compared to spontaneous recovery in patients presenting with SIPE without hypoxia. 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 and oxygen saturation ≥92% are randomly assigned to 2 groups: (1) PEP-device for 20 minutes or (2) control group with spontaneous recovery without active treatment for 20 minutes. Assessment with outcome measures is taken 10 minutes after intervention/control. Primary endpoint: oxygen saturation (%) by pulse oxymetry.
Interventions
- Device PEP-device
PEP-device
Primary outcome measures
- Absolute peripheral oxygen saturation (%) after treatment [Time frame: after 20 min treatment followed by 10 min rest]
Secondary outcome measures (8)
- Change in absolute peripheral oxygen saturation (%) before and after treatment [Time frame: change before versus after 20 min treatment followed by 10 min rest]
- Recovery (yes/no) after treatment [Time frame: after 20 min treatment followed by 10 min rest]
- Interstitial syndrome assessed by lung ultrasound (yes/no) after treatment [Time frame: after 20 min treatment followed by 10 min rest]
- Absolute number of regions presenting B-lines on lung ultrasound after treatment [Time frame: 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 [Time frame: change before versus after 20 min treatment followed by 10 min rest]
- Change in patient reported outcome measures before and after treatment [Time frame: change before versus after 20 min treatment followed by 10 min rest]
- Admission to hospital (yes/no) [Time frame: 1 hour]
- Total treatment time [Time frame: 1 hour]
Eligibility criteria
Inclusion criteria
- clinical diagnosis of swimming induced pulmonary edema (SIPE) with need of acute treatment
- peripheral oxygen saturation ≥92%
- 18 years or older
- informed consent
Exclusion criteria
- declined consent
- suspected acute coronary syndrome
- severe asthma diagnosed together with pulmonary edema with requirement of beta-agonist-inhalation prior to treatment of pulmonary edema
- hemodynamic instability or decreased consciousness
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Sweden · 1 center
- Center of Clinical Research Dalarna — Falun
Identifiers
NCT: NCT05227222 · SIPE PEP-device001