Ignite Creation Date:
2025-12-25 @ 4:23 AM
Ignite Modification Date:
2025-12-26 @ 3:25 AM
Study NCT ID:
NCT06984120
Status:
RECRUITING
Last Update Posted:
2025-08-22
First Post:
2025-05-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Increased Extravascular Lung Water in Asymptomatic Open-water Swimmers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011654', 'term': 'Pulmonary Edema'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000089382', 'term': 'Oxygen Saturation'}, {'id': 'D001831', 'term': 'Body Temperature'}], 'ancestors': [{'id': 'D008660', 'term': 'Metabolism'}, {'id': 'D055986', 'term': 'Vital Signs'}, {'id': 'D010808', 'term': 'Physical Examination'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 570}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-06-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2028-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-18', 'studyFirstSubmitDate': '2025-05-14', 'studyFirstSubmitQcDate': '2025-05-14', 'lastUpdatePostDateStruct': {'date': '2025-08-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Interstitial syndrome assessed by lung ultrasound (yes/no)', 'timeFrame': 'Within 1 hour after termination of swimming', 'description': '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.'}, {'measure': 'Number of regions presenting B-lines on lung ultrasound', 'timeFrame': 'Within 1 hour after termination of swimming', 'description': '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.'}, {'measure': 'Absolute number of B-lines on lung ultrasound', 'timeFrame': 'Within 1 hour after termination of swimming', 'description': 'Four chest regions for both lungs are scanned by lung ultrasound; the absolute number of B-lines in each region is counted.'}], 'secondaryOutcomes': [{'measure': 'Peripheral oxygen saturation', 'timeFrame': 'Within 1 hour after termination of swimming', 'description': 'Peripheral oxygen saturation measured by non-invasive pulse oxymetry'}, {'measure': 'Presence of crackles on lung auscultation (yes/no)', 'timeFrame': 'Within 1 hour after termination of swimming', 'description': 'Presence of crackles on lung auscultation'}, {'measure': 'Body temperature', 'timeFrame': 'Within 1 hour after termination of swimming', 'description': 'Body temperature measured by ear thermometer'}, {'measure': 'Interstitial syndrome assessed by lung ultrasound (yes/no)', 'timeFrame': 'At follow up within 4 hours after termination of swimming', 'description': '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.'}, {'measure': 'Number of regions presenting B-lines on lung ultrasound', 'timeFrame': 'At follow up within 4 hours after termination of swimming', 'description': '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.'}, {'measure': 'Absolute number of B-lines on lung ultrasound', 'timeFrame': 'At follow up within 4 hours after termination of swimming', 'description': '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.'}, {'measure': 'Absolute number of B-lines on lung ultrasound', 'timeFrame': 'At baseline 2-4 hours before swimming', 'description': 'Four chest regions for both lungs are scanned by lung ultrasound; the absolute number of B-lines in each region is counted.'}, {'measure': 'Peripheral oxygen saturation', 'timeFrame': 'At baseline 2-4 hours before swimming.', 'description': 'Peripheral oxygen saturation measured by non-invasive pulse oxymetry'}, {'measure': 'Body temperature', 'timeFrame': 'At baseline 2-4 hours before swimming.', 'description': 'Body temperature measured by ear thermometer'}, {'measure': 'Perceived exertion during swimming', 'timeFrame': 'Within 1 hour after termination of swimming', 'description': '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).'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pulmonary edema', 'asymptomatic pulmonary edema', 'swimming induced pulmonary edema', 'SIPE', 'pulmonary edema in swimmers', 'extravascular lung water'], 'conditions': ['Pulmonary Edema - Acute', 'Extravascular Lung Water']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nPrevious 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.\n\nThis 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Completion of an open-water swimming race during the "Vansbrosimningen" open-water swimming event\n* No respiratory symptoms (dyspnea and/or cough) during or right after the race\n* Age ≥ 18 years\n\nExclusion Criteria:\n\n* Presence of respiratory symptoms (dyspnea and/or cough) during or right after the swimming race\n* Declines participation'}, 'identificationModule': {'nctId': 'NCT06984120', 'briefTitle': 'Increased Extravascular Lung Water in Asymptomatic Open-water Swimmers', 'organization': {'class': 'OTHER', 'fullName': 'Dalarna County Council, Sweden'}, 'officialTitle': 'Increased Extravascular Lung Water in Asymptomatic Open-water Swimmers', 'orgStudyIdInfo': {'id': 'SIPE - asymptomatic swimmers'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Asymptomatic swimmers', 'description': 'Swimmers (18 years or older) finishing an open-water swimming race during the "Vansbrosimningen" open water swimming event, Sweden, without respiratory symptoms.', 'interventionNames': ['Diagnostic Test: Lung ultrasound', 'Diagnostic Test: Peripheral oxygen saturation', 'Diagnostic Test: Lung auscultation', 'Diagnostic Test: Body temperature']}], 'interventions': [{'name': 'Lung ultrasound', 'type': 'DIAGNOSTIC_TEST', 'description': '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.', 'armGroupLabels': ['Asymptomatic swimmers']}, {'name': 'Peripheral oxygen saturation', 'type': 'DIAGNOSTIC_TEST', 'description': 'Peripheral oxygen saturation measured by non-invasive pulse oxymetry', 'armGroupLabels': ['Asymptomatic swimmers']}, {'name': 'Lung auscultation', 'type': 'DIAGNOSTIC_TEST', 'description': 'Clinical auscultation of lungs', 'armGroupLabels': ['Asymptomatic swimmers']}, {'name': 'Body temperature', 'type': 'DIAGNOSTIC_TEST', 'description': 'Body temperature measured by ear thermometer.', 'armGroupLabels': ['Asymptomatic swimmers']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Falun', 'state': 'Dalarna County', 'status': 'NOT_YET_RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Maria Hårdstedt, MD, PhD', 'role': 'CONTACT', 'email': 'maria.hardstedt@regiondalarna.se', 'phone': '+46738089464', 'phoneExt': '+46'}], 'facility': 'Center of Clinical Research Dalarna', 'geoPoint': {'lat': 60.60357, 'lon': 15.62597}}, {'zip': '79182', 'city': 'Falun', 'status': 'RECRUITING', 'country': 'Sweden', 'facility': 'Center of Clinical Research Dalarna', 'geoPoint': {'lat': 60.60357, 'lon': 15.62597}}], 'centralContacts': [{'name': 'Maria Hårdstedt, MD, PhD', 'role': 'CONTACT', 'email': 'maria.hardstedt@regiondalarna.se', 'phone': '+46738089464'}, {'name': 'Claudia Seiler, MD. PhD-student', 'role': 'CONTACT'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dalarna County Council, Sweden', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr. Maria Hårdstedt, PhD, Specialist Internal Medicine', 'investigatorFullName': 'Maria Hårdstedt', 'investigatorAffiliation': 'Dalarna County Council, Sweden'}}}}