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OpenTrials
Completed

NCT Number: NCT02432131

Decompression Sickness in Divers With or Without Patent Foramen Ovale

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.

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Key information

Conditions

Foramen Ovale, Patent Barotrauma Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Decompression Sickness Heart Defects, Congenital Heart Diseases Heart Septal Defects Heart Septal Defects, Atrial Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Sejong general hospital, 91-121 Sosa 2-Dong, Sosa-Gu

Bucheon-si, Gyeonggi-do, 422-711, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. Cutaneous or neurological decompression sickness

    Time frame: Three years

  2. All symptoms requiring recompression chamber therapy

    Time frame: Three years

  3. All symptoms developed during ascending or within 30minute after surfacing

    Time frame: Three years

  4. Unexplained death within 2 weeks after diving

    Time frame: Three years

Sponsors and collaborators

Lead sponsor

Sejong General Hospital

Other

Collaborators

  • Sejong Research Institute

Registry information

Official study title

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

Acronym: DIVER-PFO

Important dates

Study start
2015
Primary completion
2021
Study completion
2021
First posted
May 1, 2015
Registry last updated
Aug 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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