PEP-device for Treatment of Swimming-induced Pulmonary Edema (SIPE)

Not Applicable

Recruiting

• Conditions: Pulmonary Edema; Swimming Induced Pulmonary Edema (SIPE); Lung Diseases
• Interventions: Device: PEP-device

• Registration Number: NCT05227222
• Lead Sponsor: Dalarna County Council, Sweden

Brief 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 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.

Study Timeline

• Study First Submitted: 2022-01-26
• Study First Submitted QC: 2022-01-26
• Study First Posted: 2022-02-07
• Study Start: 2022-07-02
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-25
• Last Update Posted: 2025-02-27
• Primary Completion: 2027-07-15
• Study Completion: 2027-07-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PEP-device	PEP-device	Positive expiratory pressure device: continuous treatment with PEP-device breathing air for 20 minutes followed by 10 minutes rest and assessment. Inspiration through nose/mouth, expiration through device.

Primary Outcome Measures

Name	Time	Method
Absolute peripheral oxygen saturation (%) after treatment	after 20 min treatment followed by 10 min rest	Peripheral oxygen saturation % (continuous variable) measured by peripheral pulse oximetry

Secondary Outcome Measures

Name	Time	Method
Interstitial syndrome assessed by lung ultrasound (yes/no) after treatment	after 20 min treatment followed by 10 min rest	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
Change in absolute peripheral oxygen saturation (%) before and after treatment	change before versus after 20 min treatment followed by 10 min rest	Change in peripheral oxygen saturation % (continuous variable) measured by pulse oximetry before and after treatment
Recovery (yes/no) after treatment	after 20 min treatment followed by 10 min rest	Recovery, defined by "peripheral oxygen saturation \>95% after treatment" or no recovery, defined by "peripheral oxygen saturation ≤95% after treatment"
Absolute number of regions presenting B-lines on lung ultrasound after treatment	after 20 min treatment followed by 10 min rest	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.
Total treatment time	1 hour	Total treatment time until oxygen saturation ≥96% is reached
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	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 in patient reported outcome measures before and after treatment	change before versus after 20 min treatment followed by 10 min rest	Six different patient reported outcome measures assessed by numerical rating scale (NRS; min-max 0-10): cough, sputum, air hunger, breathing effort, tightness in chest, anxiousness. The patients will assess symptoms prior to and after treatment
Admission to hospital (yes/no)	1 hour	Admission to hospital within or after a maximal treatment time of 1 hour

Trial Locations

Locations (1)

Center of Clinical Research Dalarna; 🇸🇪 Falun, Sweden