Decompression Sickness in Divers With or Without Patent Foramen Ovale

Completed

• Conditions: Foramen Ovale, Patent; Decompression Sickness

• Registration Number: NCT02432131
• Lead Sponsor: Sejong General Hospital

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 Timeline

• Study First Submitted: 2015-04-28
• Study First Submitted QC: 2015-04-30
• Study Start: 2015-05
• Study First Posted: 2015-05-01
• Primary Completion: 2021-02
• Study Completion: 2021-02
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-18
• Last Update Posted: 2021-08-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
PFO-related decompression sickness	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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Sejong general hospital, 91-121 Sosa 2-Dong, Sosa-Gu; 🇰🇷 Bucheon, Gyeonggi, Korea, Republic of