Decompression Sickness in Divers With or Without Patent Foramen Ovale

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02432131

Acronym

DIVER-PFO

Enrollment

100

Registered

2015-05-01

Start date

2015-05-31

Completion date

2021-02-28

Last updated

2021-08-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Decompression Sickness, Foramen Ovale, Patent

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame
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

Countries

South Korea

Outcome results