Immersion Clinical Trial
Official title:
Sildenafil for Prevention of Swimming-Induced Pulmonary Edema (SIPE)
Verified date | October 2022 |
Source | Duke University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This trial is testing the effectiveness of a single oral dose of sildenafil (50 mg) taken 1 hour before a provocative event on the subsequent development of swimming-induced pulmonary edema.
Status | Completed |
Enrollment | 18 |
Est. completion date | October 29, 2021 |
Est. primary completion date | October 29, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 45 Years |
Eligibility | Inclusion Criteria: - Healthy volunteers between 18 and 45 years - History of swimming-induced pulmonary edema Exclusion Criteria: - Pregnant women - Significant heart valve disease - Cardiomyopathy - Uncontrolled hypertension - Coronary artery disease - Obstructive lung disease - VO2max <25 mL/kg as estimated by the University of Houston Non-Exercise Test - Previous adverse reaction to sildenafil - Use of antihypertensives or other drugs that are known to interact adversely with sildenafil (e.g. nitrates, alpha adrenergic blockers) |
Country | Name | City | State |
---|---|---|---|
United States | Duke University Medical Center | Durham | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Duke University | United States Department of Defense |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Participants With Pulmonary Edema | One or more of: hypoxemia, productive cough, pulmonary edema on chest radiograph, wheezing on chest auscultation. | During or immediately after exercise in cold water, approximately one hour and 40 minutes | |
Secondary | Number of Participants With Dyspnea Leading to Voluntary Premature Cessation of Exercise | Voluntary premature cessation of exercise due to shortness of breath. | During or immediately after exercise in cold water, approximately one hour and 40 minutes | |
Secondary | Number of Participants With Post-exercise 10% Decrease in Forced Vital Capacity (FVC) or Forced Expiratory Volume in One Second (FEV1) as Measured by Spirometry | Post-exercise 10% decrease in forced vital capacity (FVC) or forced expiratory volume in one second (FEV1). | Immediately after exercise in cold water, approximately one hour and 40 minutes | |
Secondary | Number of Participants With "Comet Tails" Seen on Ultrasound of the Lungs | A "comet tail" artefact is a short path reverberation artefact that weakens with each reverberation, resulting in a vertical echogenic artefact that rapidly fades as it continues in to the ultrasound image. | Immediately after exercise in cold water, approximately one hour and 40 minutes | |
Secondary | Number of Participants Who Found the Exercise Easiest When Given Sildenafil Citrate Versus When Given Placebo | Immediately after exercise in cold water, approximately one hour and 40 minutes |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03057392 -
Head Out Water Immersion for Hemodynamic Stability During Dialysis
|
N/A | |
Completed |
NCT01782625 -
Hypercapnia: Cognitive Effects and Monitoring
|
N/A | |
Completed |
NCT01799343 -
Water Immersion and Changes in the Fetoplacental Circulation
|
N/A | |
Recruiting |
NCT05510141 -
Virtual Reality Games in Pediatric Surgery
|
N/A |