Ultrasound Investigation Into Swimming Induced Pulmonary Edema in Open Water Swimming Athletes

NCT06384885 | Recruiting

• 1 other identifier: 2024-079
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

Swimming-induced pulmonary edema (SIPE) is a potentially life-threatening condition that can affect swimmers of all abilities. The pathophysiology is not well understood and early identification strategies are not established. Handheld ultrasound is a validated tool for the identification of pulmonary edema and is not well-studied in this population. Understanding the incidence of signs of pulmonary edema and its usefulness as a sign of early pulmonary edema would be beneficial This study evaluates triathletes and open water swimmers at endurance events. A validated protocol for lung ultrasound is used to identify the signs of pulmonary edema. The findings will be analyzed for differences in experience level, type of athlete, gender, age, and environmental factors. The findings may then be used in the future to aid in the early identification and treatment of athletes and military personnel in similar situations to decrease morbidity and mortality.

Conditions

Swimming Induced Pulmonary Edema

Outcome Measures

Primary Outcomes (1)

• Lung ultrasound

  Evaluate for significant amount of B lines

  at triathlon- immediately after race

Study Arms (1)

Triathletes/Open water swimmers

Triathletes and open water swimmers in events at Boulder Ironman, St George Ironman and Without limits swim events

Diagnostic Test: Ultrasound

Interventions

Ultrasound DIAGNOSTIC_TEST

Lung ultrasound

Triathletes/Open water swimmers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Triathletes and open water swimmers at participating races.

You may qualify if:

• Participants must be Athletes competing in the event
• Must have engaged in a portion of the swimming leg of the race

You may not qualify if:

• \- Any acutely decompensating patient who requires focused medical care and evacuation as determined by race physicians
• Patients who are pregnant
• Patients less than 18 years of age
• Athletes who did not participate in the swim portion

Sponsors & Collaborators

• Rocky Vista University, LLC: lead

Study Sites (1)

Rocky Vista University

Parker, Colorado, 80012, United States

RECRUITING

Related Publications (6)

• Morgan WJ, Taussig LM. The chronic bronchitis complex in children. Pediatr Clin North Am. 1984 Aug;31(4):851-64. doi: 10.1016/s0031-3955(16)34649-1.

  PMID: 6146959 BACKGROUND

• Toker C. Observations on the ultrastructure of a mammary ductule. J Ultrastruct Res. 1967 Nov;21(1):9-25. doi: 10.1016/s0022-5320(67)80003-0. No abstract available.

  PMID: 5583207 BACKGROUND

• Peirce EC 2nd. A comparison of the Lande-Edwards, the Peirce, and the General Electric-Peirce membrane lungs. Trans Am Soc Artif Intern Organs. 1970;16:358-64. No abstract available.

  PMID: 5454185 BACKGROUND

• Hardstedt M, Seiler C, Kristiansson L, Lundeqvist D, Klingberg C, Braman Eriksson A. Swimming-Induced Pulmonary Edema: Diagnostic Criteria Validated by Lung Ultrasound. Chest. 2020 Oct;158(4):1586-1595. doi: 10.1016/j.chest.2020.04.028. Epub 2020 Apr 28.

  PMID: 32360726 BACKGROUND

• Woollard KV. The Quality in Australian Health Care Study. Med J Aust. 1996 Mar 4;164(5):315. doi: 10.5694/j.1326-5377.1996.tb94205.x. No abstract available.

  PMID: 8628172 BACKGROUND

• Wester TE, Cherry AD, Pollock NW, Freiberger JJ, Natoli MJ, Schinazi EA, Doar PO, Boso AE, Alford EL, Walker AJ, Uguccioni DM, Kernagis D, Moon RE. Effects of head and body cooling on hemodynamics during immersed prone exercise at 1 ATA. J Appl Physiol (1985). 2009 Feb;106(2):691-700. doi: 10.1152/japplphysiol.91237.2008. Epub 2008 Nov 20.

  PMID: 19023017 BACKGROUND

MeSH Terms

Interventions

Ultrasonography

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2024
• First Posted: April 25, 2024
• Study Start: April 15, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: July 31, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: starting 2025 and ongoing
• Access Criteria: They will need to contact us to share data

Locations

US (1)