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Nitrogen Bubble Detection After Simulated Dives in Divers With PFO and After PFO Closure

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ClinicalTrials.gov Identifier: NCT01854281
Recruitment Status : Completed
First Posted : May 15, 2013
Results First Posted : December 18, 2013
Last Update Posted : December 18, 2013
Sponsor:
Information provided by (Responsible Party):
Jakub Honek, MD, University Hospital, Motol

Brief Summary:
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.

Condition or disease
Patent Foramen Ovale

Detailed Description:

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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Study Type : Observational
Actual Enrollment : 47 participants
Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Nitrogen Bubble Detection After Simulated Dives in Divers With PFO and After PFO Closure
Study Start Date : May 2013
Actual Primary Completion Date : July 2013
Actual Study Completion Date : July 2013

Group/Cohort
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.



Primary Outcome Measures :
  1. Arterial Nitrogen Bubbles After Surfacing [ Time Frame: assesed within 1 hour after surfacing ]
    Arterial gas bubbles are detected by transcranial doppler ultrasonography. Positive outcome is 1 or more bubbles detected.



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
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.
Criteria

Inclusion Criteria:

  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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01854281


Locations
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Czech Republic
Department of Cardiology, University Hospital Motol
Prague, Czech Republic, 15006
Sponsors and Collaborators
University Hospital, Motol
Investigators
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Study Chair: Josef Veselka, MD, PhD Department of Cardiology, UH Motol
Study Director: Jakub Honek, MD Department of cardiology, UH Motol

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jakub Honek, MD, MD, University Hospital, Motol
ClinicalTrials.gov Identifier: NCT01854281     History of Changes
Other Study ID Numbers: EK-1929/12
First Posted: May 15, 2013    Key Record Dates
Results First Posted: December 18, 2013
Last Update Posted: December 18, 2013
Last Verified: October 2013
Keywords provided by Jakub Honek, MD, University Hospital, Motol:
Patent foramen ovale
Catheter-based closure
Nitrogen bubbles
Decompression sickness
Additional relevant MeSH terms:
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Foramen Ovale, Patent
Heart Septal Defects, Atrial
Heart Septal Defects
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities