Clinical trial NCT05227222: PEP-device for Treatment of Swimming-induced Pulmonary Edema (SIPE)
Official title: Evaluation of Positive Expiratory Pressure Device (PEP-device) for Treatment of Swimming Induced Pulmonary Edema (SIPE) - a Randomized Single-blinded Controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Swimming Induced Pulmonary Edema (SIPE)
Pulmonary Edema
Lung Diseases
Keywords: positive expiratory pressure
therapeutics
ultrasonography
oximetry
Lead sponsor: Dalarna County Council, Sweden
Sponsor class: OTHER
First posted: 2022-02-07
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Absolute peripheral oxygen saturation (%) after treatment
timeFrame: after 20 min treatment followed by 10 min rest
Secondary outcomes:
measure: Change in absolute peripheral oxygen saturation (%) before and after treatment
timeFrame: change before versus after 20 min treatment followed by 10 min rest
measure: Recovery (yes/no) after treatment
timeFrame: after 20 min treatment followed by 10 min rest
measure: Interstitial syndrome assessed by lung ultrasound (yes/no) after treatment
timeFrame: after 20 min treatment followed by 10 min rest
measure: Absolute number of regions presenting B-lines on lung ultrasound after treatment
timeFrame: after 20 min treatment followed by 10 min rest
measure: Change in absolute number of regions presenting B-lines on lung ultrasound before and after treatment
timeFrame: change before versus after 20 min treatment followed by 10 min rest
measure: Change in patient reported outcome measures before and after treatment
timeFrame: change before versus after 20 min treatment followed by 10 min rest
measure: Admission to hospital (yes/no)
timeFrame: 1 hour
measure: Total treatment time
timeFrame: 1 hour
Other outcomes:
Locations:
city: Falun
country: Sweden
facility: Center of Clinical Research Dalarna
Study officials:
References: