Incidences of Decompression Sickness in SCUBA DIVERs With or Without Patent Foramen Ovale (DIVER-PFO); A Double-blinded, Prospective Cohort Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- PFO-related decompression sickness
Study Overview
Brief Summary
The investigators will prospectively estimate incidences of decompression sickness in SCUBA divers with or without patent foramen ovale (PFO). All participants will receive transesophageal echocardiogram and transcranial doppler to ascertain whether they get a PFO. Clinical follow up will be undertaken 3 month after transesophageal echocardiographic evaluation, and every 6 month up to 3 years by E-mailing or telephone interview with self-questionnaire report. All decompression sickness (DC) events or DC-like symptoms will be reviewed by a professional diver, who is a medical doctor and member of DAN-AP, and a neurologist.
Detailed Description
PFO was defined as transesophageal echocardiographic (TEE) evidence of infused microbubbles in the left atrium within three cardiac cycles after their appearance in the right atrium, at rest or during Valsalva release. If TEE finding will not be conclusive, we will decide the presence or absence of PFO with supplementary transcranial doppler. It will be blinded to participants, physicians and research persons to perform clinical follow-up. It will be not officially recorded, and will be preserved by another research person, who will not contact study participants.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Divers who experienced fifty dives per year
Exclusion Criteria
- •Decompression sickness within recent 20 dives
- •Previous procedure or surgery for closure of PFO or ASD
- •Previous cerebral infarction or hemorrhage
- •Previous epilepsy
- •Previous angina or myocardial infarction
Outcomes
Primary Outcomes
PFO-related decompression sickness
Time Frame: Three years
Three-year cumulative incidences of cutaneous or neurological decompression sickness, all symptoms requiring recompression chamber therapy, all symptoms developed during ascending or within 30minute after surfacing, or unexplained death within 2 weeks after diving
Secondary Outcomes
- All symptoms developed during ascending or within 30minute after surfacing(Three years)
- All symptoms requiring recompression chamber therapy(Three years)
- Cutaneous or neurological decompression sickness(Three years)
- Unexplained death within 2 weeks after diving(Three years)
Investigators
Hyun Jong Lee
MD, PhD
Sejong General Hospital