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NCT Number: NCT05227222

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

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.

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Key information

Conditions

Swimming Induced Pulmonary Edema (SIPE) Lung Diseases Pulmonary Edema Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Center of Clinical Research Dalarna

Falun, 79182, Sweden

Location status: Recruiting

Location contact

Maria Hårdstedt, MD/PhD

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PEP-device

Device

PEP-device

Primary outcomes

  1. Absolute peripheral oxygen saturation (%) after treatment

    Time frame: after 20 min treatment followed by 10 min rest

    Peripheral oxygen saturation % (continuous variable) measured by peripheral pulse oximetry

Secondary outcomes

  1. Change in absolute peripheral oxygen saturation (%) before and after treatment

    Time frame: 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

  2. Recovery (yes/no) after treatment

    Time frame: 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"

  3. Interstitial syndrome assessed by lung ultrasound (yes/no) after treatment

    Time frame: 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

  4. Absolute number of regions presenting B-lines on lung ultrasound after treatment

    Time frame: 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.

  5. 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

    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

  6. Change in patient reported outcome measures before and after treatment

    Time frame: 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

  7. Admission to hospital (yes/no)

    Time frame: 1 hour

    Admission to hospital within or after a maximal treatment time of 1 hour

  8. Total treatment time

    Time frame: 1 hour

    Total treatment time until oxygen saturation ≥96% is reached

Study contacts

Contact information is provided by the study sponsor or research team.

Maria Hårdstedt, MD/PhD

CONTACT

[email protected]

46-738089464

Sponsors and collaborators

Lead sponsor

Dalarna County Council, Sweden

Other

Registry information

Official study title

Evaluation of Positive Expiratory Pressure Device (PEP-device) for Treatment of Swimming Induced Pulmonary Edema (SIPE) - a Randomized Single-blinded Controlled Study

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Feb 7, 2022
Registry last updated
Feb 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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