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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Lung Diseases; Pulmonary Edema; Swimming Induced Pulmonary Edema (SIPE)
• Intervention / Treatment: Device: PEP-device

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 Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Maria Hårdstedt, MD/PhD; Phone Number: 46-738089464; Email: maria.hardstedt@regiondalarna.se

Study Locations

• Sweden
  • Falun, Sweden, 79182
    • Recruiting
    • Center of Clinical Research Dalarna
    • Contact: Maria Hårdstedt, MD/PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: PEP-device; PEP-device
No Intervention: spontaneous recovery; Control group: Resting and breathing air for 20 + 10 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Absolute peripheral oxygen saturation (%) after treatment	Peripheral oxygen saturation % (continuous variable) measured by peripheral pulse oximetry	after 20 min treatment followed by 10 min rest

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in absolute peripheral oxygen saturation (%) before and after treatment	Change in peripheral oxygen saturation % (continuous variable) measured by pulse oximetry before and after treatment	change before versus after 20 min treatment followed by 10 min rest
Recovery (yes/no) after treatment	Recovery, defined by "peripheral oxygen saturation >95% after treatment" or no recovery, defined by "peripheral oxygen saturation ≤95% after treatment"	after 20 min treatment followed by 10 min rest
Absolute number of regions presenting B-lines on lung ultrasound after treatment	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.	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	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 before versus after 20 min treatment followed by 10 min rest
Interstitial syndrome assessed by lung ultrasound (yes/no) after treatment	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	after 20 min treatment followed by 10 min rest
Change in patient reported outcome measures before and after treatment	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	change before versus after 20 min treatment followed by 10 min rest
Admission to hospital (yes/no)	Admission to hospital within or after a maximal treatment time of 1 hour	1 hour
Total treatment time	Total treatment time until oxygen saturation ≥96% is reached	1 hour

Collaborators and Investigators

• Sponsor: Dalarna County Council, Sweden

Study record dates

Study Major Dates

• Study Start (Actual): July 2, 2022
• Primary Completion (Estimated): July 15, 2025
• Study Completion (Estimated): July 15, 2025

Study Registration Dates

• First Submitted: January 26, 2022
• First Submitted That Met QC Criteria: January 26, 2022
• First Posted (Actual): February 7, 2022

Study Record Updates

• Last Update Posted (Actual): January 10, 2024
• Last Update Submitted That Met QC Criteria: January 9, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: positive expiratory pressure; ultrasonography; oximetry; therapeutics
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Edema; Pulmonary Edema
• Other Study ID Numbers: SIPE PEP-device001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No