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

NCT05227222 | Recruiting

• 1 other identifier: SIPE PEP-device001
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Swimming Induced Pulmonary Edema (SIPE); Pulmonary Edema; Lung Diseases

Keywords

positive expiratory pressure; therapeutics; ultrasonography; oximetry

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

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

  change before versus after 20 min treatment followed by 10 min rest

• Recovery (yes/no) after treatment

  after 20 min treatment followed by 10 min rest

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

  after 20 min treatment followed by 10 min rest

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

  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

  change before versus after 20 min treatment followed by 10 min rest

Study Arms (2)

PEP-device

EXPERIMENTAL

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

spontaneous recovery

NO INTERVENTION

Control group: Resting and breathing air for 20 + 10 minutes.

Interventions

PEP-device DEVICE

PEP-device

PEP-device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• clinical diagnosis of swimming induced pulmonary edema (SIPE) with need of acute treatment
• peripheral oxygen saturation ≥92%
• years or older
• informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Dalarna County Council, Sweden: lead

Study Sites (1)

Center of Clinical Research Dalarna

Falun, 79182, Sweden

RECRUITING

MeSH Terms

Conditions

Pulmonary Edema; Lung Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Central Study Contacts

Maria Hårdstedt, MD/PhD

CONTACT

46-738089464; maria.hardstedt@regiondalarna.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Maria Hårdstedt, PhD, Specialist Internal Medicine

Study Record Dates

• First Submitted: January 26, 2022
• First Posted: February 7, 2022
• Study Start: July 2, 2022
• Primary Completion (Estimated): July 15, 2027
• Study Completion (Estimated): July 15, 2027
• Last Updated: February 27, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)