Increased Extravascular Lung Water in Asymptomatic Open-water Swimmers

NCT ID: NCT06984120

Last Updated: 2025-08-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

570 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-06-29

Study Completion Date

2028-12-30

Brief Summary

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Previous studies suggest that increased extravascular lung water might be found in open water swimmers without respiratory symptoms. This study aims to investigate a large number of asymptomatic individuals after an open-water swimming race to assess the prevalence of increased extravascular lung water in asymptomatic open-water swimmers.

Detailed Description

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Swimming-induced pulmonary edema (SIPE) can occur during open-water swimming. The pathophysiological mechanisms are still partly unknown, but central pooling of blood volume and peripheral vasoconstriction have been suggested as important factors. SIPE is characterized by acute onset of dyspnea and cough, sometimes with excessive sputum and hemoptysis. The condition usually resolves spontaneously, but medical attention can be required in more severe cases.

Previous studies suggest that SIPE is diagnosed by clinical symptoms, decreased peripheral oxygen saturation and signs of pulmonary edema on lung ultrasound. Interestingly, signs of increased extravascular lung water have been found in divers without respiratory symptoms. There are no similar studies regarding open-water swimmers.

This study aims to investigate a large number of swimmers without respiratory symptoms after finishing an open-water swimming race. Prevalence and amount of increased extravascular lung water after swimming will be assessed by lung ultrasound. In addition, individual baseline factors and information about the race associated with increased extravascular lung water will be evaluated. This study will provide better understanding of the pathophysiological mechanism of SIPE.

Conditions

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Pulmonary Edema - Acute Extravascular Lung Water

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Asymptomatic swimmers

Swimmers (18 years or older) finishing an open-water swimming race during the "Vansbrosimningen" open water swimming event, Sweden, without respiratory symptoms.

Lung ultrasound

Intervention Type DIAGNOSTIC_TEST

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.

Peripheral oxygen saturation

Intervention Type DIAGNOSTIC_TEST

Peripheral oxygen saturation measured by non-invasive pulse oxymetry

Lung auscultation

Intervention Type DIAGNOSTIC_TEST

Clinical auscultation of lungs

Body temperature

Intervention Type DIAGNOSTIC_TEST

Body temperature measured by ear thermometer.

Interventions

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Lung ultrasound

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.

Intervention Type DIAGNOSTIC_TEST

Peripheral oxygen saturation

Peripheral oxygen saturation measured by non-invasive pulse oxymetry

Intervention Type DIAGNOSTIC_TEST

Lung auscultation

Clinical auscultation of lungs

Intervention Type DIAGNOSTIC_TEST

Body temperature

Body temperature measured by ear thermometer.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Completion of an open-water swimming race during the "Vansbrosimningen" open-water swimming event
* No respiratory symptoms (dyspnea and/or cough) during or right after the race
* Age ≥ 18 years

Exclusion Criteria

* Presence of respiratory symptoms (dyspnea and/or cough) during or right after the swimming race
* Declines participation
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Dalarna County Council, Sweden

OTHER

Sponsor Role lead

Responsible Party

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Maria Hårdstedt

Dr. Maria Hårdstedt, PhD, Specialist Internal Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Center of Clinical Research Dalarna

Falun, Dalarna County, Sweden

Site Status NOT_YET_RECRUITING

Center of Clinical Research Dalarna

Falun, , Sweden

Site Status RECRUITING

Countries

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Sweden

Central Contacts

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Maria Hårdstedt, MD, PhD

Role: CONTACT

+46738089464

Claudia Seiler, MD. PhD-student

Role: CONTACT

Facility Contacts

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Maria Hårdstedt, MD, PhD

Role: primary

+46738089464 ext. +46

Other Identifiers

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SIPE - asymptomatic swimmers

Identifier Type: -

Identifier Source: org_study_id

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