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

NCT ID: NCT01854281

Last Updated: 2013-12-18

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

47 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-05-31

Study Completion Date

2013-07-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Patent Foramen Ovale

Keywords

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Patent foramen ovale Catheter-based closure Nitrogen bubbles Decompression sickness

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Patent foramen ovale dive A group

Divers with a previously diagnosed patent foramen ovale observed after Dive A.

No interventions assigned to this group

Closure dive A group

Divers with a patent foramen ovale previously closed by a catheter-based procedure observed after Dive A.

No interventions assigned to this group

patent foramen ovale dive B group

Divers with a previously diagnosed patent foramen ovale observed after Dive B.

No interventions assigned to this group

closure dive B group

Divers with a patent foramen ovale previously closed by a catheter-based procedure observed after Dive B.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Motol

OTHER

Sponsor Role lead

Responsible Party

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Jakub Honek, MD

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Josef Veselka, MD, PhD

Role: STUDY_CHAIR

Department of Cardiology, UH Motol

Jakub Honek, MD

Role: STUDY_DIRECTOR

Department of cardiology, UH Motol

Locations

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Department of Cardiology, University Hospital Motol

Prague, , Czechia

Site Status

Countries

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Czechia

References

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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.

Reference Type DERIVED
PMID: 24630875 (View on PubMed)

Other Identifiers

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EK-1929/12

Identifier Type: -

Identifier Source: org_study_id