NCT06984120

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
609

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2025

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 14, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 22, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

June 29, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2025

Completed
Last Updated

February 18, 2026

Status Verified

February 1, 2026

Enrollment Period

1 month

First QC Date

May 14, 2025

Last Update Submit

February 16, 2026

Conditions

Pulmonary Edema - AcuteExtravascular Lung Water

Keywords

pulmonary edemaasymptomatic pulmonary edemaswimming induced pulmonary edemaSIPEpulmonary edema in swimmersextravascular lung water

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    Within 1 hour after termination of swimming

Secondary Outcomes (10)

  • Peripheral oxygen saturation

    Within 1 hour after termination of swimming

  • Presence of crackles on lung auscultation (yes/no)

    Within 1 hour after termination of swimming

  • Body temperature

    Within 1 hour after termination of swimming

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

    At follow up within 4 hours after termination of swimming

  • Number of regions presenting B-lines on lung ultrasound

    At follow up within 4 hours after termination of swimming

  • +5 more secondary outcomes

Study Arms (1)

Asymptomatic swimmers

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

Diagnostic Test: Lung ultrasoundDiagnostic Test: Peripheral oxygen saturationDiagnostic Test: Lung auscultationDiagnostic Test: Body temperature

Interventions

Body temperatureDIAGNOSTIC_TEST

Body temperature measured by ear thermometer.

Asymptomatic swimmers
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.

Asymptomatic swimmers
Peripheral oxygen saturationDIAGNOSTIC_TEST

Peripheral oxygen saturation measured by non-invasive pulse oxymetry

Asymptomatic swimmers
Lung auscultationDIAGNOSTIC_TEST

Clinical auscultation of lungs

Asymptomatic swimmers

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

  • Presence of respiratory symptoms (dyspnea and/or cough) during or right after the swimming race
  • Declines participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Center of Clinical Research Dalarna

Falun, Dalarna County, Sweden

Location

Center of Clinical Research Dalarna

Falun, 79182, Sweden

Location

MeSH Terms

Conditions

Pulmonary Edema

Interventions

Oxygen SaturationBody Temperature

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

MetabolismVital SignsPhysical ExaminationDiagnostic Techniques and ProceduresDiagnosisPhysiological Phenomena

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Maria Hårdstedt, PhD, Specialist Internal Medicine

Study Record Dates

First Submitted

May 14, 2025

First Posted

May 22, 2025

Study Start

June 29, 2025

Primary Completion

July 30, 2025

Study Completion

July 30, 2025

Last Updated

February 18, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

SE(2)