An observational study in Foramen Ovale, Patent and Decompression Sickness, sponsored by Sejong General Hospital. Completed at 1 site in Korea, Republic of. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-08-24.
Sponsored by Sejong General Hospital · Observational
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.
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.
Recreational or occupational SCUBA (self-contained underwater breathing apparatus) divers
Exclusion Criteria:
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
Time frame: Three years
Cutaneous or neurological decompression sickness
Time frame: Three years
All symptoms requiring recompression chamber therapy
Time frame: Three years
All symptoms developed during ascending or within 30minute after surfacing
Time frame: Three years
Unexplained death within 2 weeks after diving
Time frame: Three years
This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.
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Sejong General Hospital