PEP-device for Treatment of Swimming-induced Pulmonary Edema (SIPE)
Primary Purpose
Swimming Induced Pulmonary Edema (SIPE), Pulmonary Edema, Lung Diseases
Status
Recruiting
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
PEP-device
Sponsored by
About this trial
This is an interventional treatment trial for Swimming Induced Pulmonary Edema (SIPE) focused on measuring positive expiratory pressure, therapeutics, ultrasonography, oximetry
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
Sites / Locations
- Center of Clinical Research DalarnaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
PEP-device
spontaneous recovery
Arm Description
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.
Control group: Resting and breathing air for 20 + 10 minutes.
Outcomes
Primary Outcome Measures
Absolute peripheral oxygen saturation (%) after treatment
Peripheral oxygen saturation % (continuous variable) measured by peripheral pulse oximetry
Secondary Outcome Measures
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
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"
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
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.
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 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
Admission to hospital (yes/no)
Admission to hospital within or after a maximal treatment time of 1 hour
Total treatment time
Total treatment time until oxygen saturation ≥96% is reached
Full Information
NCT ID
NCT05227222
First Posted
January 26, 2022
Last Updated
July 2, 2022
Sponsor
Dalarna County Council, Sweden
1. Study Identification
Unique Protocol Identification Number
NCT05227222
Brief Title
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
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 2, 2022 (Actual)
Primary Completion Date
July 15, 2025 (Anticipated)
Study Completion Date
July 15, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dalarna County Council, Sweden
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Swimming Induced Pulmonary Edema (SIPE), Pulmonary Edema, Lung Diseases
Keywords
positive expiratory pressure, therapeutics, ultrasonography, oximetry
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
PEP-device
Arm Type
Experimental
Arm Description
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.
Arm Title
spontaneous recovery
Arm Type
No Intervention
Arm Description
Control group: Resting and breathing air for 20 + 10 minutes.
Intervention Type
Device
Intervention Name(s)
PEP-device
Intervention Description
PEP-device
Primary Outcome Measure Information:
Title
Absolute peripheral oxygen saturation (%) after treatment
Description
Peripheral oxygen saturation % (continuous variable) measured by peripheral pulse oximetry
Time Frame
after 20 min treatment followed by 10 min rest
Secondary Outcome Measure Information:
Title
Change in absolute peripheral oxygen saturation (%) before and after treatment
Description
Change in peripheral oxygen saturation % (continuous variable) measured by pulse oximetry before and after treatment
Time Frame
change before versus after 20 min treatment followed by 10 min rest
Title
Recovery (yes/no) after treatment
Description
Recovery, defined by "peripheral oxygen saturation >95% after treatment" or no recovery, defined by "peripheral oxygen saturation ≤95% after treatment"
Time Frame
after 20 min treatment followed by 10 min rest
Title
Interstitial syndrome assessed by lung ultrasound (yes/no) after treatment
Description
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
Time Frame
after 20 min treatment followed by 10 min rest
Title
Absolute number of regions presenting B-lines on lung ultrasound after treatment
Description
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.
Time Frame
after 20 min treatment followed by 10 min rest
Title
Change in absolute number of regions presenting B-lines on lung ultrasound before and after treatment
Description
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
Time Frame
change before versus after 20 min treatment followed by 10 min rest
Title
Change in patient reported outcome measures before and after treatment
Description
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
Time Frame
change before versus after 20 min treatment followed by 10 min rest
Title
Admission to hospital (yes/no)
Description
Admission to hospital within or after a maximal treatment time of 1 hour
Time Frame
1 hour
Title
Total treatment time
Description
Total treatment time until oxygen saturation ≥96% is reached
Time Frame
1 hour
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maria Hårdstedt, MD/PhD
Phone
46-738089464
Email
maria.hardstedt@regiondalarna.se
Facility Information:
Facility Name
Center of Clinical Research Dalarna
City
Falun
ZIP/Postal Code
79182
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Hårdstedt, MD/PhD
12. IPD Sharing Statement
Plan to Share IPD
No
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PEP-device for Treatment of Swimming-induced Pulmonary Edema (SIPE)
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