Clinical trial NCT06984120: Increased Extravascular Lung Water in Asymptomatic Open-water Swimmers
Official title: Increased Extravascular Lung Water in Asymptomatic Open-water Swimmers
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Pulmonary Edema - Acute
Extravascular Lung Water
Keywords: pulmonary edema
asymptomatic pulmonary edema
swimming induced pulmonary edema
SIPE
pulmonary edema in swimmers
extravascular lung water
Lead sponsor: Dalarna County Council, Sweden
Sponsor class: OTHER
First posted: 2025-05-22
Enrollment: 570
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Swimmers of all swimming skills that participate in the open-water swimming event of Vansbrosimningen - a Swedish open-water swimming event that takes place in Vansbro, Sweden

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Interstitial syndrome assessed by lung ultrasound (yes/no)
timeFrame: Within 1 hour after termination of swimming
measure: Number of regions presenting B-lines on lung ultrasound
timeFrame: Within 1 hour after termination of swimming
measure: Absolute number of B-lines on lung ultrasound
timeFrame: Within 1 hour after termination of swimming
Secondary outcomes:
measure: Peripheral oxygen saturation
timeFrame: Within 1 hour after termination of swimming
measure: Presence of crackles on lung auscultation (yes/no)
timeFrame: Within 1 hour after termination of swimming
measure: Body temperature
timeFrame: Within 1 hour after termination of swimming
measure: Interstitial syndrome assessed by lung ultrasound (yes/no)
timeFrame: At follow up within 4 hours after termination of swimming
measure: Number of regions presenting B-lines on lung ultrasound
timeFrame: At follow up within 4 hours after termination of swimming
measure: Absolute number of B-lines on lung ultrasound
timeFrame: At follow up within 4 hours after termination of swimming
measure: Absolute number of B-lines on lung ultrasound
timeFrame: At baseline 2-4 hours before swimming
measure: Peripheral oxygen saturation
timeFrame: At baseline 2-4 hours before swimming.
measure: Body temperature
timeFrame: At baseline 2-4 hours before swimming.
measure: Perceived exertion during swimming
timeFrame: Within 1 hour after termination of swimming
Other outcomes:
Locations:
city: Falun
country: Sweden
facility: Center of Clinical Research Dalarna
state: Dalarna
Study officials:
References: