Decompression Sickness in Divers With or Without Patent Foramen Ovale
DIVER-PFO
Incidences of Decompression Sickness in SCUBA DIVERs With or Without Patent Foramen Ovale (DIVER-PFO); A Double-blinded, Prospective Cohort Study
1 other identifier
observational
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started May 2015
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 28, 2015
CompletedFirst Posted
Study publicly available on registry
May 1, 2015
CompletedStudy Start
First participant enrolled
May 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2021
CompletedAugust 24, 2021
August 1, 2021
5.8 years
April 28, 2015
August 18, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
PFO-related decompression sickness
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
Three years
Secondary Outcomes (4)
Cutaneous or neurological decompression sickness
Three years
All symptoms requiring recompression chamber therapy
Three years
All symptoms developed during ascending or within 30minute after surfacing
Three years
Unexplained death within 2 weeks after diving
Three years
Study Arms (2)
Divers with PFO
Divers without PFO
Eligibility Criteria
Recreational or occupational SCUBA (self-contained underwater breathing apparatus) divers
You may qualify if:
- Divers who experienced fifty dives per year
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sejong General Hospitallead
- Sejong Research Institutecollaborator
Study Sites (1)
Sejong general hospital, 91-121 Sosa 2-Dong, Sosa-Gu
Bucheon-si, Gyeonggi-do, 422-711, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 3 Years
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD
Study Record Dates
First Submitted
April 28, 2015
First Posted
May 1, 2015
Study Start
May 1, 2015
Primary Completion
February 1, 2021
Study Completion
February 1, 2021
Last Updated
August 24, 2021
Record last verified: 2021-08