PEP-device for Treatment of Swimming-induced Pulmonary Edema (SIPE)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorDalarna County Council, Sweden
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
clinical diagnosis of swimming induced pulmonary edema (SIPE) with need of acute treatment
peripheral oxygen saturation ≥92%
18 years or older
informed consent
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
PEP-device
DevicePEP-device
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: PEP-deviceExperimental treatment 1 intervention
Group B: spontaneous recoveryNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Absolute peripheral oxygen saturation (%) after treatment
Peripheral oxygen saturation % (continuous variable) measured by peripheral pulse oximetry
Time frame
after 20 min treatment followed by 10 min restSecondary outcomes
1
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
Time frame
change before versus after 20 min treatment followed by 10 min rest2
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"
Time frame
after 20 min treatment followed by 10 min rest3
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
Time frame
after 20 min treatment followed by 10 min rest4
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.
Time frame
after 20 min treatment followed by 10 min restSponsors and contacts
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Source ClinicalTrials.gov