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The aim of this study is to determine whether catheter-based closure of patent foramen ovale is effective in preventing paradoxical embolization of nitrogen bubbles after simulated dives.
The aim of this study is to determine whether catheter-based closure of patent foramen ovale (PFO) is effective in preventing paradoxical embolization of nitrogen bubbles after simulated dives.
Ultrasonographic detection of venous and arterial nitrogen bubbles will be performed in divers after surfacing from simulated dives in hyperbaric chambers. Divers will be observed after two different dive profiles - Dive A (dive to 18 m for 80 min bottom time) and dive B (dive to 50 m for 20 min bottom time), both performed according to US Navy Air decompression procedure 1996. For both dives two groups will be compared: Divers with PFO and divers after previous catheter-based closure of PFO.
The study will be observational. Sonographic detection of bubbles will be performed after simulated dives that are part of a training program of the divers. Two different dives, previously documented to generate significant amount of venous nitrogen bubbles, were chosen.
The primary end-point will be a positive transcranial doppler test (defined as one or more bubbles detected either during native breathing or after Valsalva maneuver).
Inclusion criteria are: 1) previously diagnosed PFO or a PFO that has been occluded by a catheter-based procedure, 2) signed informed consent
Exclusion criteria: 1) another dive performed in the preceding 24 hours, 2) another previously diagnosed right-to-left shunt, 3) disagreement to be included in the study
This study will be single-center.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patent foramen ovale dive A group | Divers with a previously diagnosed patent foramen ovale observed after Dive A. | ||
| Closure dive A group | Divers with a patent foramen ovale previously closed by a catheter-based procedure observed after Dive A. | ||
| patent foramen ovale dive B group | Divers with a previously diagnosed patent foramen ovale observed after Dive B. | ||
| closure dive B group | Divers with a patent foramen ovale previously closed by a catheter-based procedure observed after Dive B. |
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| Measure | Description | Time Frame |
|---|---|---|
| Arterial Nitrogen Bubbles After Surfacing | Arterial gas bubbles are detected by transcranial doppler ultrasonography. Positive outcome is 1 or more bubbles detected. | assesed within 1 hour after surfacing |
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Inclusion Criteria:
Exclusion criteria:
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Adult scuba divers with either a previously diagnosed patent foramen ovale (PFO) or after a catheter-based PFO closure. Consecutive divers that undergo a simulated dive in hyperbaric chamber will be recruited.
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| Name | Affiliation | Role |
|---|---|---|
| Josef Veselka, MD, PhD | Department of Cardiology, UH Motol | Study Chair |
| Jakub Honek, MD | Department of cardiology, UH Motol | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Cardiology, University Hospital Motol | Prague | 15006 | Czechia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24630875 | Derived | Honek J, Sramek M, Sefc L, Januska J, Fiedler J, Horvath M, Tomek A, Novotny S, Honek T, Veselka J. Effect of catheter-based patent foramen ovale closure on the occurrence of arterial bubbles in scuba divers. JACC Cardiovasc Interv. 2014 Apr;7(4):403-8. doi: 10.1016/j.jcin.2013.12.199. Epub 2014 Mar 14. |
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No participants were excluded from the study, all enrolled participants completed the study, no transition between groups occured.
All participants were included consecutively in the Hyperbaric chamber of the Regional hospital Kladno, Kladno, Czech Republic and at Hyperbaric chamber Vyškov, Vyškov, Czech Republic, where they performed a training dive. Two dive profiles were performed (dive A and Dive B). The recruitment took part between 15/May/2013 and 15/June/2013.
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| ID | Title | Description |
|---|---|---|
| FG000 | Closure Dive A Group | Divers with a patent foramen ovale previously closed by a catheter-based procedure observed after Dive A. |
| FG001 | Patent Foramen Ovale Dive A Group | Divers with a previously diagnosed patent foramen ovale observed after Dive A. |
| FG002 | Closure Dive B Group | Divers with a patent foramen ovale previously closed by a catheter-based procedure observed after Dive B. |
| FG003 | Patent Foramen Ovale Dive B Group | Divers with a previously diagnosed patent foramen ovale observed after Dive B. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Closure Dive A Group | Divers with a patent foramen ovale previously closed by a catheter-based procedure observed after Dive A. |
| BG001 | Patent Foramen Ovale Dive A Group | Divers with a previously diagnosed patent foramen ovale observed after dive A. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Arterial Nitrogen Bubbles After Surfacing | Arterial gas bubbles are detected by transcranial doppler ultrasonography. Positive outcome is 1 or more bubbles detected. | Posted | Number | participants | assesed within 1 hour after surfacing |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Closure Dive A Group | Divers with a patent foramen ovale previously closed by a catheter-based procedure observed after Dive A. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Mild neurological symptoms of decompression sickness | Nervous system disorders | Systematic Assessment | All patients were questioned and examined by physician after the dive. Headache, fatigue, visual problems, paresthesia were considered mild neurological symptoms of decompression sickness. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jakub Honek, MD | University Hospital Motol | +42022443 | 4901 | jakub.honek@gmail.com |
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| ID | Term |
|---|---|
| D054092 | Foramen Ovale, Patent |
| D003665 | Decompression Sickness |
| ID | Term |
|---|---|
| D006344 | Heart Septal Defects, Atrial |
| D006343 | Heart Septal Defects |
| D006330 | Heart Defects, Congenital |
| D018376 | Cardiovascular Abnormalities |
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| BG002 | Closure Dive B Group | Divers with a patent foramen ovale previously closed by a catheter-based procedure observed after Dive B. |
| BG003 | Patent Foramen Ovale Dive B Group | Divers with a previously diagnosed patent foramen ovale observed after dive B. |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body mass index | Mean | Standard Deviation | kg/m2 |
|
| Number of dives | Total number of dives in history reported by the diver. | Mean | Standard Deviation | Dives |
|
| Number of decompression dives | Total number of decompression dives in history reported by the diver. | Mean | Standard Deviation | Dives |
|
| history of decompression sickness | number of divers with history of decompression sickness as reported by the divers. | Number | participants |
|
Divers with a patent foramen ovale previously closed by a catheter-based procedure observed after Dive B. |
| OG003 | Patent Foramen Ovale Dive B Group | Divers with a previously diagnosed patent foramen ovale observed after dive B. |
|
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| EG001 | Patent Foramen Ovale Dive A Group | Divers with a previously diagnosed patent foramen ovale observed after dive A. | 0 | 19 | 4 | 19 |
| EG002 | Closure Dive B Group | Divers with a patent foramen ovale previously closed by a catheter-based procedure observed after Dive B. | 0 | 5 | 0 | 5 |
| EG003 | Patent Foramen Ovale Dive B Group | Divers with a previously diagnosed patent foramen ovale observed after dive B. | 0 | 8 | 2 | 8 |
|
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| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D001469 | Barotrauma |
| D014947 | Wounds and Injuries |