Clinical Trial: Decompression Sickness in Divers With or Without Patent Foramen Ovale

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational [Patient Registry]

Official Title: Incidences of Decompression Sickness in SCUBA DIVERs With or Without Patent Foramen Ovale (DIVER-PFO); A Double-blinded, Prospective Cohort Study

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 Summary: 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.
Sponsor: Sejong General Hospital

Current Primary Outcome: 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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome: Same as current

Information By: Sejong General Hospital

Dates:
Date Received: April 28, 2015
Date Started: May 2015
Date Completion: February 2022
Last Updated: November 22, 2016
Last Verified: November 2016