Pulmonary Edema - AcuteNCT06984120
Increased Extravascular Lung Water in Asymptomatic Open-water Swimmers
An observational study of Pulmonary Edema - Acute and Extravascular Lung Water, run by Dalarna County Council, Sweden at 2 sites in Sweden.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Edema - Acute, Extravascular Lung Water
- What is being tested?
- Lung ultrasound, Peripheral oxygen saturation and Lung auscultation
- How many people
- 609 participants
- Where
- 2 sitesSweden
- Study dates
- 29 Jun 2025to 30 Jul 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- Presence of respiratory symptoms (dyspnea and/or cough) during or right after the swimming race
- Declines participation
Trial locations and contacts
2 sites in 1 country.
Sweden2 sites
Center of Clinical Research Dalarna
Falun, Dalarna County
Center of Clinical Research Dalarna
Falun, 79182
About this study
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.
Read the 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.
- Conditions
- Pulmonary Edema - Acute, Extravascular Lung Water
- Being tested
- Lung ultrasound, Peripheral oxygen saturation, Lung auscultation, Body temperature
- Keywords
- pulmonary edema, asymptomatic pulmonary edema, swimming induced pulmonary edema, SIPE, pulmonary edema in swimmers, extravascular lung water
- Medical subject headings
- Pulmonary Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lung ultrasoundDiagnostic 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 saturationDiagnostic test
Peripheral oxygen saturation measured by non-invasive pulse oxymetry
Lung auscultationDiagnostic test
Clinical auscultation of lungs
Body temperatureDiagnostic test
Body temperature measured by ear thermometer.
| Study group | Role | What they receive |
|---|---|---|
| Asymptomatic swimmers | Swimmers (18 years or older) finishing an open-water swimming race during the "Vansbrosimningen" open water swimming event, Sweden, without respiratory symptoms. Receives: Diagnostic Test: Lung ultrasound; Diagnostic Test: Peripheral oxygen saturation; Diagnostic Test: Lung auscultation; Diagnostic Test: Body temperature |
What is being measured
The primary outcome is the main question the study is designed to answer.
Interstitial syndrome assessed by lung ultrasound (yes/no)
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.
Measured: Within 1 hour after termination of swimming
Number of regions presenting B-lines on 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. Assessment of the total number of positive regions.
Measured: Within 1 hour after termination of swimming
Absolute number of B-lines on lung ultrasound
Four chest regions for both lungs are scanned by lung ultrasound; the absolute number of B-lines in each region is counted.
Measured: Within 1 hour after termination of swimming
Secondary outcomes (10)
Peripheral oxygen saturation
Peripheral oxygen saturation measured by non-invasive pulse oxymetry
Measured: Within 1 hour after termination of swimming
Presence of crackles on lung auscultation (yes/no)
Presence of crackles on lung auscultation
Measured: Within 1 hour after termination of swimming
Body temperature
Body temperature measured by ear thermometer
Measured: Within 1 hour after termination of swimming
Interstitial syndrome assessed by lung ultrasound (yes/no)
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. Performed in individuals with signs of increased extravascular lung water after swimming.
Measured: At follow up within 4 hours after termination of swimming
Number of regions presenting B-lines on 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. Assessment of the total number of positive regions. Performed in individuals with signs of increased extravascular lung water after swimming.
Measured: At follow up within 4 hours after termination of swimming
Absolute number of B-lines on lung ultrasound
Four chest regions for both lungs are scanned by lung ultrasound; the absolute number of B-lines in each region is counted in individuals with sign of increased extravascular lung water after swimming. Performed in individuals with signs of increased extravascular lung water after swimming.
Measured: At follow up within 4 hours after termination of swimming
Absolute number of B-lines on lung ultrasound
Four chest regions for both lungs are scanned by lung ultrasound; the absolute number of B-lines in each region is counted.
Measured: At baseline 2-4 hours before swimming
Peripheral oxygen saturation
Peripheral oxygen saturation measured by non-invasive pulse oxymetry
Measured: At baseline 2-4 hours before swimming.
Body temperature
Body temperature measured by ear thermometer
Measured: At baseline 2-4 hours before swimming.
Perceived exertion during swimming
Perceived exertion during the swimming race measured by "Borg rating of perceived exertion scale". Values on the scale range from a minimum value of 6 (no exertion) to a maximum value of 20 (maximal exertion).
Measured: Within 1 hour after termination of swimming
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2025
- Study start29 Jun 2025
- Primary completion30 Jul 2025
- Study completion30 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Edema - AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 609 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dalarna County Council, Sweden
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Hårdstedt, Dalarna County Council, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06984120
- Sponsor's protocol ID
- SIPE - asymptomatic swimmers
- Status last verified
- Feb 2026
- First submitted
- 14 May 2025
- Last updated
- 18 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increased Extravascular Lung Water in Asymptomatic Open-water Swimmers
- ClinicalTrials.gov ID
- NCT06984120
- Acronym / sponsor ID
- SIPE - asymptomatic swimmers
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 609 participants (actual)
- Lead sponsor
- Dalarna County Council, SwedenUniversity, hospital or other
- Study start
- 29 Jun 2025 (actual)
- Primary completion
- 30 Jul 2025 (actual)
- Study completion
- 30 Jul 2025 (actual)
- First posted
- 22 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Asymptomatic swimmers | – | Diagnostic Test: Lung ultrasound, Diagnostic Test: Peripheral oxygen saturation, Diagnostic Test: Lung auscultation, Diagnostic Test: Body temperatureSwimmers (18 years or older) finishing an open-water swimming race during the "Vansbrosimningen" open water swimming event, Sweden, without respiratory symptoms. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Presence of respiratory symptoms (dyspnea and/or cough) during or right after the swimming race
- Declines participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lung ultrasoundFour 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. | Diagnostic test | Asymptomatic swimmers |
| Peripheral oxygen saturationPeripheral oxygen saturation measured by non-invasive pulse oxymetry | Diagnostic test | Asymptomatic swimmers |
| Lung auscultationClinical auscultation of lungs | Diagnostic test | Asymptomatic swimmers |
| Body temperatureBody temperature measured by ear thermometer. | Diagnostic test | Asymptomatic swimmers |
Primary outcome
Interstitial syndrome assessed by lung ultrasound (yes/no)
Time frame: Within 1 hour after termination of swimming
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.
Number of regions presenting B-lines on lung ultrasound
Time frame: Within 1 hour after termination of swimming
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.
Absolute number of B-lines on lung ultrasound
Time frame: Within 1 hour after termination of swimming
Four chest regions for both lungs are scanned by lung ultrasound; the absolute number of B-lines in each region is counted.
10 secondary outcomes
Peripheral oxygen saturation
Time frame: Within 1 hour after termination of swimming
Presence of crackles on lung auscultation (yes/no)
Time frame: Within 1 hour after termination of swimming
Body temperature
Time frame: Within 1 hour after termination of swimming
Interstitial syndrome assessed by lung ultrasound (yes/no)
Time frame: At follow up within 4 hours after termination of swimming
Number of regions presenting B-lines on lung ultrasound
Time frame: At follow up within 4 hours after termination of swimming
Absolute number of B-lines on lung ultrasound
Time frame: At follow up within 4 hours after termination of swimming
Absolute number of B-lines on lung ultrasound
Time frame: At baseline 2-4 hours before swimming
Peripheral oxygen saturation
Time frame: At baseline 2-4 hours before swimming.
Body temperature
Time frame: At baseline 2-4 hours before swimming.
Perceived exertion during swimming
Time frame: Within 1 hour after termination of swimming
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Edema - Acute and Extravascular Lung Water, run by Dalarna County Council, Sweden at 2 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Interstitial syndrome assessed by lung ultrasound (yes/no) (time frame: Within 1 hour after termination of swimming). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2026.