Foramen Ovale, PatentDIVER-PFONCT02432131
Decompression Sickness in Divers With or Without Patent Foramen Ovale
An observational study of Foramen Ovale, Patent and Decompression Sickness, run by Sejong General Hospital at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Foramen Ovale, Patent, Decompression Sickness
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2015to Feb 2021
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Recreational or occupational SCUBA (self-contained underwater breathing apparatus) divers
Who may be able to join
- Divers who experienced fifty dives per year
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Sejong general hospital, 91-121 Sosa 2-Dong, Sosa-Gu
Bucheon-si, Gyeonggi-do, 422-711
About this study
Official title: Incidences of Decompression Sickness in SCUBA DIVERs With or Without Patent Foramen Ovale (DIVER-PFO); A Double-blinded, Prospective Cohort Study
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.
Read the 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.
- Conditions
- Foramen Ovale, Patent, Decompression Sickness
- Medical subject headings
- Foramen Ovale, Patent, Decompression Sickness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Divers with PFO | Not described | |
| Divers without PFO | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Three years
Secondary outcomes (4)
Cutaneous or neurological decompression sickness
Measured: Three years
All symptoms requiring recompression chamber therapy
Measured: Three years
All symptoms developed during ascending or within 30minute after surfacing
Measured: Three years
Unexplained death within 2 weeks after diving
Measured: Three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2015 (estimated)
- Study startMay 2015
- Primary completionFeb 2021
- Study completionFeb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Foramen Ovale, PatentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Sejong General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Sejong Research Institute
- Responsible party
- Principal investigator, Hyun Jong Lee, Sejong General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02432131
- Sponsor's protocol ID
- DIVER-PFO_ver1.1
- Acronym
- DIVER-PFO
- Status last verified
- Aug 2021
- First submitted
- 28 Apr 2015
- Last updated
- 24 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidences of Decompression Sickness in SCUBA DIVERs With or Without Patent Foramen Ovale (DIVER-PFO); A Double-blinded, Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT02432131
- Acronym / sponsor ID
- DIVER-PFO / DIVER-PFO_ver1.1
- Conditions
- Foramen Ovale, Patent, Decompression Sickness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Sejong General HospitalUniversity, hospital or other
- Collaborators
- Sejong Research Institute
- Study start
- May 2015
- Primary completion
- Feb 2021 (actual)
- Study completion
- Feb 2021 (actual)
- First posted
- 1 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Divers with PFO | – | – |
| Divers without PFO | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Recreational or occupational SCUBA (self-contained underwater breathing apparatus) divers
Key inclusion criteria (1 listed)
- Divers who experienced fifty dives per year
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
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
4 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Foramen Ovale, Patent and Decompression Sickness, run by Sejong General Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFO-related decompression sickness (time frame: Three years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2021.