Prevention and Treatment of Immersion Pulmonary Edema

Swimming Induced Pulmonary Edema (SIPE) Clinical Trial

Official title:

Effects of the Dive Reflex on Pulmonary Arterial and Pulmonary Artery Wedge Pressures in Subjects Who Have Experienced Immersion Pulmonary Edema

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00815646
• Other study ID #: Pro00003158
• Status: Completed
• Phase: Phase 0
• First received: December 26, 2008
• Last updated: January 25, 2016
• Start date: January 2008
• Est. completion date: December 2015

Study information

• Verified date: January 2016
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Immersion pulmonary edema (IPE) is a condition in which fluid fills the lungs during diving or swimming, particularly in cold water. Some individuals appear to be predisposed to developing IPE. DNA samples will be collected and stored, in order to compare the genetic profiles of individuals who have experienced IPE with those who have not. In a few individuals who have experienced IPE, we plan to measure the effects of cold water immersion on the blood pressure, cardiac output and the pressures in the pulmonary artery. These will be compared with similar measurements already obtained from normal individuals.

Description:

Immersion pulmonary edema (IPE) is a condition that has sudden onset in swimmers and divers, and is characterized by cough, shortness of breath, decreased blood oxygen levels, and hemoptysis. The purpose of this study is to examine the effects of cold water immersion and the dive reflex on pulmonary arterial pressure and pulmonary capillary wedge pressure in those who have already experienced IPE, as well as explore the possibility of a genetic predisposition. Healthy nonsmoking subjects who have experienced IPE will be recruited for several cold-water immersion experiments and DNA analysis. Their pulmonary arterial and pulmonary arterial wedge pressures will be measured as they undergo immersed rest and exercise trials in thermoneutral and cold water. If the pressures increase with these trials as hypothesized, the effects of sildenafil administration (a pulmonary vasodilator) will be tested during a second trial. Blood will also be drawn for DNA analysis of certain genes with possible relation to IPE. Results of these tests will be compared with those of the general population.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• History of immersion pulmonary edema

Exclusion Criteria:

• Coronary artery disease, cardiomyopathy, heart valve disease

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Edema
• Immersion Pulmonary Edema (IPE)
• Pulmonary Edema
• Swimming Induced Pulmonary Edema (SIPE)

Intervention

Drug:
• Sildenafil
After measurement of the effect of cold water on cardiac output and pulmonary artery and wedge pressures, a single dose of sildenafil (50 mg) will be given orally, followed by similar hemodynamic measurements.

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	Divers Alert Network

Country where clinical trial is conducted

United States, 

References & Publications (3)

Fraser JA, Peacher DF, Freiberger JJ, Natoli MJ, Schinazi EA, Beck IV, Walker JR, Doar PO, Boso AE, Walker AJ, Kernagis DN, Moon RE. Risk factors for immersion pulmonary edema: hyperoxia does not attenuate pulmonary hypertension associated with cold water-immersed prone exercise at 4.7 ATA. J Appl Physiol (1985). 2011 Mar;110(3):610-8. doi: 10.1152/japplphysiol.01088.2010. Epub 2010 Dec 9. Erratum in: J Appl Physiol. 2011 Dec;111(6):1888. — View Citation

Peacher DF, Martina SD, Otteni CE, Wester TE, Potter JF, Moon RE. Immersion pulmonary edema and comorbidities: case series and updated review. Med Sci Sports Exerc. 2015 Jun;47(6):1128-34. doi: 10.1249/MSS.0000000000000524. Review. — View Citation

Peacher DF, Pecorella SR, Freiberger JJ, Natoli MJ, Schinazi EA, Doar PO, Boso AE, Walker AJ, Gill M, Kernagis D, Uguccioni D, Moon RE. Effects of hyperoxia on ventilation and pulmonary hemodynamics during immersed prone exercise at 4.7 ATA: possible implications for immersion pulmonary edema. J Appl Physiol (1985). 2010 Jul;109(1):68-78. doi: 10.1152/japplphysiol.01431.2009. Epub 2010 Apr 29. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pulmonary artery pressure during cold water immersion		1 day	No

External Links

•   Duke Center for Hyperbaric Medicine and Environmental Physiology