Decompression Sickness in Divers With or Without Patent Foramen Ovale

Foramen Ovale, Patent Clinical Trial

— DIVER-PFO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02432131
• Other study ID #: DIVER-PFO_ver1.1
• Status: Completed
• Start date: May 2015
• Est. completion date: February 2021

Study information

• Verified date: August 2021
• Source: Sejong General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: February 2021
• Est. primary completion date: February 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Decompression Sickness
• Foramen Ovale, Patent

Locations

Country	Name	City	State
Korea, Republic of	Sejong general hospital, 91-121 Sosa 2-Dong, Sosa-Gu	Bucheon	Gyeonggi

Sponsors (2)

Lead Sponsor	Collaborator
Sejong General Hospital	Sejong Research Institute

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Cutaneous or neurological decompression sickness		Three years
Secondary	All symptoms requiring recompression chamber therapy		Three years
Secondary	All symptoms developed during ascending or within 30minute after surfacing		Three years
Secondary	Unexplained death within 2 weeks after diving		Three years